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Meta-Analysis
. 2024 Apr 10;4(4):CD003451.
doi: 10.1002/14651858.CD003451.pub3.

Orthodontic treatment for prominent lower front teeth (Class III malocclusion) in children

Darren Owens  1 , Simon Watkinson  2 , Jayne E Harrison  1 , Sarah Turner  1 , Helen V Worthington  3
Affiliations
Meta-Analysis

Orthodontic treatment for prominent lower front teeth (Class III malocclusion) in children

Darren Owens et al. Cochrane Database Syst Rev. .

Abstract

Background: Prominent lower front teeth (Class III malocclusion) may be due to jaw or tooth position or both. The upper jaw (maxilla) can be too far back or the lower jaw (mandible) too far forward; the upper front teeth (incisors) may be tipped back or the lower front teeth tipped forwards. Orthodontic treatment uses different types of braces (appliances) fitted inside or outside the mouth (or both) and fixed to the teeth. A facemask is the most commonly reported non-surgical intervention used to correct Class III malocclusion. The facemask rests on the forehead and chin, and is connected to the upper teeth via an expansion appliance (known as 'rapid maxillary expansion' (RME)). Using elastic bands placed by the wearer, a force is applied to the top teeth and jaw to pull them forwards and downward. Some orthodontic interventions involve a surgical component; these go through the gum into the bone (e.g. miniplates). In severe cases, or if orthodontic treatment is unsuccessful, people may need jaw (orthognathic) surgery as adults. This review updates one published in 2013.

Objectives: To assess the effects of orthodontic treatment for prominent lower front teeth in children and adolescents.

Search methods: An information specialist searched four bibliographic databases and two trial registries up to 16 January 2023. Review authors screened reference lists.

Selection criteria: We looked for randomised controlled trials (RCTs) involving children and adolescents (16 years of age or under) randomised to receive orthodontic treatment to correct prominent lower front teeth (Class III malocclusion), or no (or delayed) treatment.

Data collection and analysis: We used standard methodological procedures expected by Cochrane. Our primary outcome was overjet (i.e. prominence of the lower front teeth); our secondary outcomes included ANB (A point, nasion, B point) angle (which measures the relative position of the maxilla to the mandible).

Main results: We identified 29 RCTs that randomised 1169 children (1102 analysed). The children were five to 13 years old at the start of treatment. Most studies measured outcomes directly after treatment; only one study provided long-term follow-up. All studies were at high risk of bias as participant and personnel blinding was not possible. Non-surgical orthodontic treatment versus untreated control We found moderate-certainty evidence that non-surgical orthodontic treatments provided a substantial improvement in overjet (mean difference (MD) 5.03 mm, 95% confidence interval (CI) 3.81 to 6.25; 4 studies, 184 participants) and ANB (MD 3.05°, 95% CI 2.40 to 3.71; 8 studies, 345 participants), compared to an untreated control group, when measured immediately after treatment. There was high heterogeneity in the analyses, but the effects were consistently in favour of the orthodontic treatment groups rather than the untreated control groups (studies tested facemask (with or without RME), chin cup, orthodontic removable traction appliance, tandem traction bow appliance, reverse Twin Block with lip pads and RME, Reverse Forsus and mandibular headgear). Longer-term outcomes were measured in only one study, which evaluated facemask. It presented low-certainty evidence that improvements in overjet and ANB were smaller at 3-year follow-up than just after treatment (overjet MD 2.5 mm, 95% CI 1.21 to 3.79; ANB MD 1.4°, 95% CI 0.43 to 2.37; 63 participants), and were not found at 6-year follow-up (overjet MD 1.30 mm, 95% CI -0.16 to 2.76; ANB MD 0.7°, 95% CI -0.74 to 2.14; 65 participants). In the same study, at the 6-year follow-up, clinicians made an assessment of whether surgical correction of participants' jaw position was likely to be needed in the future. A perceived need for surgical correction was observed more often in participants who had not received facemask treatment (odds ratio (OR) 3.34, 95% CI 1.21 to 9.24; 65 participants; low-certainty evidence). Surgical orthodontic treatment versus untreated control One study of 30 participants evaluated surgical miniplates, with facemask or Class III elastics, against no treatment, and found a substantial improvement in overjet (MD 7.96 mm, 95% CI 6.99 to 8.40) and ANB (MD 5.20°, 95% CI 4.48 to 5.92; 30 participants). However, the evidence was of low certainty, and there was no follow-up beyond the end of treatment. Facemask versus another non-surgical orthodontic treatment Eight studies compared facemask or modified facemask (with or without RME) to another non-surgical orthodontic treatment. Meta-analysis did not suggest that other treatments were superior; however, there was high heterogeneity, with mixed, uncertain findings (very low-certainty evidence). Facemask versus surgically-anchored appliance There may be no advantage of adding surgical anchorage to facemasks for ANB (MD -0.35, 95% CI -0.78 to 0.07; 4 studies, 143 participants; low-certainty evidence). The evidence for overjet was of very low certainty (MD -0.40 mm, 95% CI -1.30 to 0.50; 1 study, 43 participants). Facemask variations Adding RME to facemask treatment may have no additional benefit for ANB (MD -0.15°, 95% CI -0.94 to 0.64; 2 studies, 60 participants; low-certainty evidence). The evidence for overjet was of low certainty (MD 1.86 mm, 95% CI 0.39 to 3.33; 1 study, 31 participants). There may be no benefit in terms of effect on ANB of alternating rapid maxillary expansion and constriction compared to using expansion alone (MD -0.46°, 95% CI -1.03 to 0.10; 4 studies, 131 participants; low-certainty evidence).

Authors' conclusions: Moderate-certainty evidence showed that non-surgical orthodontic treatments (which included facemask, reverse Twin Block, orthodontic removable traction appliance, chin cup, tandem traction bow appliance and mandibular headgear) improved the bite and jaw relationship immediately post-treatment. Low-certainty evidence showed surgical orthodontic treatments were also effective. One study measured longer-term outcomes and found that the benefit from facemask was reduced three years after treatment, and appeared to be lost by six years. However, participants receiving facemask treatment were judged by clinicians to be less likely to need jaw surgery in adulthood. We have low confidence in these findings and more studies are required to reach reliable conclusions. Orthodontic treatment for Class III malocclusion can be invasive, expensive and time-consuming, so future trials should include measurement of adverse effects and patient satisfaction, and should last long enough to evaluate whether orthodontic treatment in childhood avoids the need for jaw surgery in adulthood.

Trial registration: ClinicalTrials.gov NCT02144324 clinicaltrials.gov/show/NCT03354442 clinicaltrials.gov/show/NCT04310267 clinicaltrials.gov/show/NCT04387175 clinicaltrials.gov/ct2/show/NCT04825951 clinicaltrials.gov/ct2/show/NCT04863404 NCT04911400 https://clinicaltrials.gov/ct2/show/NCT05089396.

PubMed Disclaimer

Conflict of interest statement

Darren J Owens: no interests to declare. Simon Watkinson: no interests to declare. Jayne E Harrison: I am an Editor with Cochrane Oral Health, but I was not involved in the editorial processing of this review update. No interests to declare. Sarah Turner: no interests to declare. Helen V Worthington: I am an Editor with Cochrane Oral Health and was formerly a Co‐ordinating Editor running the group, but I was not involved in the editorial processing of this review update. No interests to declare.

Figures

1
1
Study flow diagram
2
2
Risk of bias summary: review authors' judgements about each risk of bias item for each included study
3
3
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies
4
4
Non‐surgical orthodontic treatment versus no treatment for prominent lower front teeth in children ‐ analysis 1.1: overjet
5
5
Non‐surgical orthodontic treatment versus no treatment for prominent lower front teeth in children ‐ analysis 1.1: ANB
1.1
1.1. Analysis
Comparison 1: Non‐surgical orthodontic treatment versus untreated control (short term, 9 to 15 months), Outcome 1: Overjet
1.2
1.2. Analysis
Comparison 1: Non‐surgical orthodontic treatment versus untreated control (short term, 9 to 15 months), Outcome 2: ANB
1.3
1.3. Analysis
Comparison 1: Non‐surgical orthodontic treatment versus untreated control (short term, 9 to 15 months), Outcome 3: Wits
1.4
1.4. Analysis
Comparison 1: Non‐surgical orthodontic treatment versus untreated control (short term, 9 to 15 months), Outcome 4: Piers‐Harris self‐concept scale
2.1
2.1. Analysis
Comparison 2: Non‐surgical orthodontic treatment versus untreated control (long term, 3 to 6 years), Outcome 1: Overjet
2.2
2.2. Analysis
Comparison 2: Non‐surgical orthodontic treatment versus untreated control (long term, 3 to 6 years), Outcome 2: ANB
2.3
2.3. Analysis
Comparison 2: Non‐surgical orthodontic treatment versus untreated control (long term, 3 to 6 years), Outcome 3: Piers‐Harris self‐concept scale
2.4
2.4. Analysis
Comparison 2: Non‐surgical orthodontic treatment versus untreated control (long term, 3 to 6 years), Outcome 4: Oral Aesthetic Subjective Impact Score (OASIS)
2.5
2.5. Analysis
Comparison 2: Non‐surgical orthodontic treatment versus untreated control (long term, 3 to 6 years), Outcome 5: Need for surgery in adulthood (6‐year follow‐up)
3.1
3.1. Analysis
Comparison 3: Surgical orthodontic treatment versus untreated control, Outcome 1: Overjet
3.2
3.2. Analysis
Comparison 3: Surgical orthodontic treatment versus untreated control, Outcome 2: ANB
4.1
4.1. Analysis
Comparison 4: Facemask (RME) or modified facemask versus other non‐surgical appliance, Outcome 1: Overjet
4.2
4.2. Analysis
Comparison 4: Facemask (RME) or modified facemask versus other non‐surgical appliance, Outcome 2: ANB
4.3
4.3. Analysis
Comparison 4: Facemask (RME) or modified facemask versus other non‐surgical appliance, Outcome 3: Wits appraisal
5.1
5.1. Analysis
Comparison 5: Facemask (RME) or modified facemask versus surgically‐anchored appliance, Outcome 1: Overjet
5.2
5.2. Analysis
Comparison 5: Facemask (RME) or modified facemask versus surgically‐anchored appliance, Outcome 2: ANB
5.3
5.3. Analysis
Comparison 5: Facemask (RME) or modified facemask versus surgically‐anchored appliance, Outcome 3: Wits
6.1
6.1. Analysis
Comparison 6: Bone‐anchored intermaxillary traction (BAIMT) versus removable mandibular retractor (RMR), Outcome 1: Overjet
6.2
6.2. Analysis
Comparison 6: Bone‐anchored intermaxillary traction (BAIMT) versus removable mandibular retractor (RMR), Outcome 2: ANB
7.1
7.1. Analysis
Comparison 7: Facemask (RME) versus facemask only, Outcome 1: Overjet
7.2
7.2. Analysis
Comparison 7: Facemask (RME) versus facemask only, Outcome 2: ANB
7.3
7.3. Analysis
Comparison 7: Facemask (RME) versus facemask only, Outcome 3: Wits
8.1
8.1. Analysis
Comparison 8: Facemask (RME) versus facemask (Alt‐RAMEC), Outcome 1: ANB
8.2
8.2. Analysis
Comparison 8: Facemask (RME) versus facemask (Alt‐RAMEC), Outcome 2: Wits
8.3
8.3. Analysis
Comparison 8: Facemask (RME) versus facemask (Alt‐RAMEC), Outcome 3: A‐NPerp
9.1
9.1. Analysis
Comparison 9: Facemask (after Alt‐RAMEC) versus facemask (before Alt‐RAMEC), Outcome 1: Overjet
9.2
9.2. Analysis
Comparison 9: Facemask (after Alt‐RAMEC) versus facemask (before Alt‐RAMEC), Outcome 2: ANB
9.3
9.3. Analysis
Comparison 9: Facemask (after Alt‐RAMEC) versus facemask (before Alt‐RAMEC), Outcome 3: Wits
10.1
10.1. Analysis
Comparison 10: Facemask (RME) versus facemask (Nanda), Outcome 1: ANB
11.1
11.1. Analysis
Comparison 11: Chin cup (600 g) versus chin cup (300 g), Outcome 1: ANB
11.2
11.2. Analysis
Comparison 11: Chin cup (600 g) versus chin cup (300 g), Outcome 2: Wits
12.1
12.1. Analysis
Comparison 12: Hybrid Hyrax (RME) with miniscrews and Class III elastics versus conventional Hyrax (RME) with miniscrews and Class III elastics, Outcome 1: Overjet
12.2
12.2. Analysis
Comparison 12: Hybrid Hyrax (RME) with miniscrews and Class III elastics versus conventional Hyrax (RME) with miniscrews and Class III elastics, Outcome 2: ANB
12.3
12.3. Analysis
Comparison 12: Hybrid Hyrax (RME) with miniscrews and Class III elastics versus conventional Hyrax (RME) with miniscrews and Class III elastics, Outcome 3: Wits
13.1
13.1. Analysis
Comparison 13: Surgical miniplates (facemask) versus surgical miniplates (Class III elastics), Outcome 1: Overjet
13.2
13.2. Analysis
Comparison 13: Surgical miniplates (facemask) versus surgical miniplates (Class III elastics), Outcome 2: ANB
See this image and copyright information in PMC

Update of

References

References to studies included in this review

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Liu 2013 {published data only}
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Liu 2015 {published data only}
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Ma 2009 {published data only}
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Majanni 2016 {published data only}
    1. Hajeer MY. Re: "Evaluation of pain, discomfort and acceptance during the orthodontic treatment of Class III malocclusion" [personal correspondence]. Email to: D Owens 17 September 2020.
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Mandall 2010 {published data only}
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Minase 2019 {published data only}
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Miranda 2021 {published and unpublished data}
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Seiryu 2020 {published and unpublished data}
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Showkatbakhsh 2012 {published data only}
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Showkatbakhsh 2013 {published data only}
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Vaughn 2005 {published data only}
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Xu 2001 {published data only}
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Yao 2015 {published data only}
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References to studies excluded from this review

Akhoundi 2009 {published data only}
    1. Akhoundi MS, Khorshidian A, Kharrazi-Fard MJ. Comparison of face mask treatment with or without expansion screw in dentoskeletal changes of Class III patients. Journal of Islamic Dental Association of Iran 2009;21(3):186-93.
Altug 1989 {published data only}
    1. Altuğ Z, Erdem D, Rübendüz M. Investigation of the effect of functional treatment in skeletal Class III cases on the profile facial esthetics. Turkish Journal of Orthodontics 1989;3(1):39-44. - PubMed
Arman 2004 {published data only}
    1. Arman AA, Toygar TU, Abuhijleh E. Profile changes associated with different orthopedic treatment approaches in Class III malocclusions. Angle Orthodontist 2004;74(6):733-40. - PubMed
Arman 2006 {published data only}
    1. Arman A, Toygar TU, Abuhijleh E. Evaluation of maxillary protraction and fixed appliance therapy in Class III patients. European Journal of Orthodontics 2006;28(4):383-92. - PubMed
Baik 1995 {published data only}
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Barrett 2010 {published data only}
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Bavbek 2014 {published data only}
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Biren 1993 {published data only}
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Bozkaya 2017 {published data only}
    1. Bozkaya E, Yuksel AS, Bozkaya S. Zygomatic miniplates for skeletal anchorage in orthopedic correction of Class III malocclusion: a controlled clinical trial. Korean Journal of Orthodontics 2017;47(2):118-29. [DOI: 10.4041/kjod.2017.47.2.118] - DOI - PMC - PubMed
Celebi 2020 {published data only}
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Celikoglu 2014 {published data only}
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Celikoglu 2017 {published data only}
    1. Celikoglu M, Buyukcavus MH. Changes in pharyngeal airway dimensions and hyoid bone position after maxillary protraction with different alternate rapid maxillary expansion and construction protocols: a prospective clinical study. Angle Orthodontist 2017;87(4):519-25. [DOI: 10.2319/082316-632.1] - DOI - PMC - PubMed
Cha 2011 {published data only}
    1. Cha BK, Ngan PW. Skeletal anchorage for orthopedic correction of growing Class III patients. Seminars in Orthodontics 2011;17(2):124-37. [DOI: ]
Chen 2011 {published data only}
    1. Chen L, Chen R, Yang Y, Ji G, Shen G. The effects of maxillary protraction and its long-term stability—a clinical trial in Chinese adolescents. European Journal of Orthodontics 2012;34(1):88-95. [DOI: 10.1093/ejo/cjq185] - DOI - PubMed
Cozza 2004 {published data only}
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El 2010 {published data only}
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Erdur 2020 {published data only}
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Goyenc 2004 {published data only}
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Halicioglu 2014 {published data only}
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He 2013 {published data only}
    1. He S, Gao J, Wamalwa P, Wang Y, Zou S, Chen S. Camouflage treatment of skeletal Class III malocclusion with multiloop edgewise arch wire and modified Class III elastics by maxillary mini-implant anchorage. Angle Orthodontist 2013;83(4):630-40. - PMC - PubMed
Hino 2014 {published data only}
    1. Hino CT, Cevidanes LHS, Nguyen TT, Clerck HJ, Franchi L, McNamara Jr JA. Three-dimensional analysis of maxillary changes associated with facemask and rapid maxillary expansion compared with bone anchored maxillary protraction. American Journal of Orthodontics and Dentofacial Orthopedics 2014;144(5):705-14. - PMC - PubMed
Ierardo 2018 {published data only}
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Isci 2010 {published data only}
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Kaygisiz 2022 {published data only}
    1. Kaygisiz E, Ocakoglu G, Kurnaz M, Yuksel S, Tortop T. Geometric morphometric analysis of the pharyngeal airway during treatment of Class III malocclusion. American Journal of Orthodontics and Dentofacial Orthopedics 2022;162(3):374-85. [DOI: 10.1016/j.ajodo.2021.04.028] [PMID: ] - DOI - PubMed
Kilicoglu 1998 {published data only}
    1. Kilicoglu H, Kirlic Y. Profile changes in patients with class III malocclusions after Delaire mask therapy. American Journal of Orthodontics and Dentofacial Orthopedics 1998;113(4):453-62. [DOI: 10.1016/S0889-5406(98)80018-8] - DOI - PubMed
Kurt 2011 {published data only}
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Lee 2012 {published data only}
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Loca‐Apichai 2022 {published data only}
    1. Loca-Apichai P, Jein-Wein Liou E. Redirecting mandibular growth through orthodontic dentoalveolar height development in growing patients with Class III malocclusion undergoing maxillary orthopedic protraction. American Journal of Orthodontics and Dentofacial Orthopedics 2022;162(4):510-9. [DOI: 10.1016/j.ajodo.2021.05.013] [PMID: ] - DOI - PubMed
Lucchi 2022 {published data only}
    1. Lucchi P, Rosa M, Bruno G, De Stefani A, Zalunardo F, Gracco A. Difference in using protrusion face mask before or after rapid palatal expansion in skeletal Class III children: a preliminary study. Children (Basel) 2022;9(10):1535. [DOI: 10.3390/children9101535] [PMID: ] - DOI - PMC - PubMed
Miamoto 2017 {published data only}
    1. Miamoto CB, Marques LS, Abreu LG, Paiva SM. Comparison of two early treatment protocols for anterior dental crossbite in the mixed dentition: a randomized trial. Angle Orthodontist 2017;88(2):144-50. [DOI: 10.2319/052117-344.1] - DOI - PMC - PubMed
Mucedero 2007 {published data only}
    1. Mucedero M, Baccetti T, Franchi L, Cozza P. Effects of maxillary protraction with or without expansion on the sagittal pharyngeal dimensions in Class III subjects. American Journal of Orthodontics and Dentofacial Orthopedics 2007;135(6):777-81. - PubMed
Papageorgiou 2016 {published data only}
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Pavoni 2009 {published data only}
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Pilehvar 2021 {published data only}en.irct.ir/trial/38226
    1. Bozorgnia Y, Mafinezhad S, Pilehvar P, Salari S. Introducing a removable orthodontic appliance and Its effects on dental arch dimensions. International Journal of Clinical Pediatric Dentistry 2021;14(Suppl 1):S39-43. [PMID: ] - PMC - PubMed
    1. IRCT20190311043006N1. Introducing a new removable orthodontic appliance and its effect on dental arch dimentions in patient who need proclination in anterior teeth. www.irct.ir/trial/38226 (first received 24 April 2019).
Saleh 2013 {published data only}
    1. Saleh M, Hajeer MY, Al-Jundi A. Assessment of pain and discomfort during early orthodontic treatment of skeletal Class III malocclusion using the removable mandibular retractor appliance. European Journal of Paediatric Dentistry 2013;14:119-24. - PubMed
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Sar 2011 {published data only}
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Zaidao 2017 {published data only}
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Zere 2018 {published data only}
    1. Zere E, Chaudhari PK, Sharan J, Dhingra K, Tiwari N. Developing Class III malocclusions: challenges and solutions. Clinical, Cosmetic and Investigational Dentistry 2018;10:99-116. [DOI: 10.2147/CCIDE.S134303] - DOI - PMC - PubMed
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References to studies awaiting assessment

Liu 2022 {published data only}
    1. ChiCTR2000034909. Effect of maxillary protraction with alternate rapid maxillary expansions and constrictions in maxillary retrusive patients: a randomized controlled trial. www.chictr.org.cn/showprojEN.html?proj=56648 (first received 24 July 2020). [PMID: ]
    1. Liu WT, Wang YR, Wang XD, Zhou YH. [A cone-beam computed tomography evaluation of three-dimensional changes of circummaxillary sutures following maxillary protraction with alternate rapid palatal expansions and constrictions]. Journal of Peking University (Health Sciences) 2022;54(2):346-55. [DOI: 10.19723/j.issn.1671-167X.2022.02.024] [PMID: ] - DOI - PMC - PubMed

References to ongoing studies

ACTRN12622000310763 {published data only}44620
    1. ACTRN12622000310763. Evaluation of two types of treatment for adolescent patients with protrusion of lower jaw and constriction of upper jaw. anzctr.org.au/ACTRN12622000310763.aspx (first received 18 March 2021).
ISRCTN12197405 {published data only}www.who.int/trialsearch/Trial2.aspx?TrialID=ISRCTN12197405
    1. ISRCTN12197405. An investigation of treating patients with conventional and skeletal anchored protraction headgear. www.isrctn.com/ISRCTN12197405 (first received 2 April 2020).
ISRCTN93900866 {published data only}16053293900866
    1. ISRCTN93900866. A clinical trial to assess the effectiveness of miniplate surgical treatment to bring the upper jaw forwards in 11-14 years old children. www.isrctn.com/ISRCTN93900866 (first received 19 September 2014).
NCT02711111 {published data only}
    1. NCT02711111. Effect of bone-anchored protraction on maxillary growth in the young child. clinicaltrials.gov/ct2/show/NCT02711111 (first received 17 March 2016). [CLINICALTRIALS.GOV: NCT02711111]
NCT03354442 {published data only}
    1. NCT03354442. Treatment of Class III malocclusion using modified fixed mandibular retractor appliance. clinicaltrials.gov/ct2/show/NCT03354442 (first received 28 November 2017).
NCT04310267 {published data only}
    1. NCT04310267. Three levels of force application for maxillary protraction (MaxiProtr). clinicaltrials.gov/ct2/show/NCT04310267 (first received 17 March 2020).
NCT04387175 {published data only}
    1. NCT0438715. Intraoral device vs facial mask for Class III treatment. clinicaltrials.gov/ct2/show/NCT04387175 (first received 13 May 2020).
NCT04825951 {published data only}
    1. NCT04825951. Dentofacial effects of two non-compliance appliances In the treatment of growing skeletal Class III patients. clinicaltrials.gov/ct2/show/NCT04825951 (first received 1 April 2021).
NCT04863404 {published data only}
    1. NCT4863404. Evaluation of the treatment effects of tooth borne versus bone-anchored protraction procedures in Class III patients with maxillary deficiency. clinicaltrials.gov/ct2/show/NCT04863404 (first received 28 April 2021).
NCT04911400 {published data only}
    1. NCT04911400. Effects of Class III elastics on stability of orthopaedic Class III correction. clinicaltrials.gov/ct2/show/NCT04911400 (first received 3 June 2021).
NCT05089396 {published data only}
    1. NCT05089396. Effects of conventional versus skeletally anchored facemask in treatment of the prepubertal skeletal Class III patients. clinicaltrials.gov/ct2/show/NCT05089396 (first received 22 October 2021).
NCT05345756 {published data only}44683
    1. NCT05345756. Intraoral maxillary protraction technique vs facemask using Alt-RAMEC protocol for treatment Class III growing patients (ALT-RAMEC). clinicaltrials.gov/ct2/show/NCT05345756 (first received 26 April 2022).
NCT05475548 {published data only}44771
    1. NCT05475548. Effect of skeletally anchored reversed PowerScope appliance in orthodontic treatment of patients with Class III malocclusion. clinicaltrials.gov/ct2/show/NCT05475548 (first received 27 July 2023).

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Watkinson 2013
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