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Randomized Controlled Trial
. 2025 Apr;36(4):436-448.
doi: 10.1111/clr.14393. Epub 2024 Dec 20.

Bone Substitute Material in the Surgical Therapy of Peri-Implantitis-3-Year Outcomes of a Randomized Controlled Trial

Lamija Alibegovic  1 , Anna Trullenque-Eriksson  1 , Alberto Ortiz-Vigón  2   3 , Adrián Guerrero  4 , Mauro Donati  1 , Eriberto Bressan  5 , Karolina Karlsson  1   6 , Carlotta Dionigi  1 , Erik Regidor  2 , Yuki Ichioka  1 , Cristiano Tomasi  1 , Paolo Ghensi  7 , Dennis Schaller  8 , Ingemar Abrahamsson  1   6 , Tord Berglundh  1   6 , Jan Derks  1   6
Affiliations
Randomized Controlled Trial

Bone Substitute Material in the Surgical Therapy of Peri-Implantitis-3-Year Outcomes of a Randomized Controlled Trial

Lamija Alibegovic et al. Clin Oral Implants Res. 2025 Apr.

Abstract

Objective: To evaluate the potential mid-term benefit of the use of a bone substitute material in the reconstructive surgical treatment of peri-implantitis.

Methods: A total of 120 subjects (127 implants) affected by peri-implantitis were followed over 3 years in a multicenter randomized clinical trial. Participants had been randomized to either control (access flap surgery) or test group (access flap surgery and bone substitute material). Clinical, radiographic, and patient-reported outcomes were assessed. The primary outcome was a composite measure including probing pocket depth ≤ 5 mm, absence of bleeding and suppuration on probing, soft tissue recession ≤ 1 mm, and implant neither reoperated nor lost. In an additional outcome (disease resolution), we allowed for one bleeding site and did not consider recession.

Results: While 14 implants (11%) were lost and a second surgical intervention had been performed at 3 implants (2.4%), pronounced improvements of clinical parameters were noted at remaining implants in both treatment groups at the 3-year follow-up. This was illustrated by a 3.2-3.5 mm reduction in probing pocket depth and a marginal bone level gain of 1.1-1.3 mm. The primary composite outcome, however, was only achieved at 14% of implants. The second composite outcome defining disease resolution was accomplished at 39% of implants. Patient-reported outcomes were generally favorable.

Conclusion: At 3 years, the use of a bone substitute material in the surgical therapy of peri-implantitis did not result in a clear benefit over access flap surgery alone.

Trial registration: ClinicalTrials.gov identifier: NCT0307706.

Keywords: dental implant; peri‐implantitis; reconstructive therapy; surgical therapy.

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Conflict of interest statement

Drs. Alibegovic, Trullenque‐Eriksson, Ichioka, Dionigi, and Regidor report no conflict of interest. Dr. Ortiz‐Vigón reports speakers honoraria from Straumann Group and Arrow Development research and financial support from ThinkingPerio research. Dr. Guerrero reports honoraria from Inibsa and Dentsply Sirona Implants. Dr. Donati reports speakers honoraria from Dentsply Sirona Implants and research grants from Dentsply Sirona Implants. Dr. Bressan reports speakers honoraria from Dentsply Sirona Implants and Sweden & Martina. Dr. Ghensi reports speakers honoraria from Geistlich Pharma AG and BioHorizons Camlog. Dr. Schaller reports speakers honoraria from Zimmer Biomet. Dr. Tomasi reports speakers honoraria from Dentsply Sirona Implants, Straumann Group, Geistlich Pharma AG, and Sweden & Martina. Dr. Karlsson reports speakers honoraria from Dentsply Sirona Implants. Dr. Abrahamsson reports research grants from Dentsply Sirona Implants. Dr. Berglundh reports honoraria from Dentsply Sirona Implants, speakers honoraria from Osteology Foundation and research grants from Dentsply Sirona Implants, Osteology Foundation and Geistlich Pharma AG. Dr. Derks reports speakers honoraria from Osteology Foundation, Dentsply Sirona Implants, Straumann Group and research grants from Eklund Foundation and Electro Medical Systems.

Figures

FIGURE 1
FIGURE 1
Flowchart illustrating the number of participants throughout the study period.
FIGURE 2
FIGURE 2
Alluvial plots illustrating implant status by study arm over the 3‐year follow‐up period.
FIGURE 3
FIGURE 3
Clinical photographs and radiographs depicting two cases showing favorable outcomes (examples 1 and 2) and one case (example 3) displaying pronounced disease progression.
FIGURE A1
FIGURE A1
Spaghetti plots and cumulative distribution curves illustrating alterations of probing pocket depth, marginal bone levels, and buccal soft tissue levels. The shaded lines represent single implants up to the latest observation. Group estimates and 95% CIs were generated by an unadjusted mixed‐effects model using implant and time point as levels.
FIGURE A2
FIGURE A2
Probability of recurrence at implant sites with a favorable outcome (PPD ≤ 5 mm) at year 1. Recurrence was defined as: PPD ≥ 6 mm, lost or re‐surgery at/by year 3.
See this image and copyright information in PMC

References

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