Assessment of Outcomes of Immediately Loaded Dental Implants in Orofacial Cleft Patients: Protocol for a Single-Arm Clinical Trial

Abstract

Background: Orofacial cleft, one of the most common congenital deformities, presents with a plethora of defects, subjecting the patient to a multitude of treatments from a young age. Among the oral hard tissue problems, absence of a maxillary permanent tooth in the cleft region either due to congenital absence or extraction due to compromised prognosis is a common finding. Conventionally, the missing tooth is replaced using a removable or fixed partial denture; however, the treatment modality does not satisfactorily meet patient expectations. The most recent decade has seen increasing use of dental implants in the cleft region; however, the outcome of an immediately loaded dental implant is still elusive for orofacial cleft patients.

Objective: This protocol is for a single-arm clinical trial aimed at determining the treatment outcome of immediately loaded dental implants in patients with a nonsyndromic orofacial cleft.

Methods: Patients meeting the set criteria will be sequentially enrolled until a sample size of 30 dental implants is met and will undergo the proposed treatment according to the predecided protocol. All patients will be followed up at the designated time intervals to record various clinical and radiographic parameters. Implant success will be defined based on the criteria elucidated by Misch et al in the Pisa, Italy Consensus. A quality-of-life assessment questionnaire will also be recorded at the end of patient's follow-up to determine their acceptance of the treatment.

Results: A total of 30 dental implants will be placed in patients with a nonsyndromic orofacial cleft. Obtained results will be statistically analyzed to determine the treatment outcomes and success.

Conclusions: This study will help determine the feasibility of immediately loaded dental implants in compromised bone sites such as those presented in cleft patients and will help in generating findings that can be used to fill the lacunae currently present in the holistic treatment of cleft patients.

Trial registration: Clinical Trial Registry of India CTRI/2020/09/027997; http://ctri.nic.in/Clinicaltrials/showallp.php?mid1=47659&EncHid=&userName=dental%20implants.

International registered report identifier (irrid): PRR1-10.2196/25244.

Keywords: clinical trial protocols; dental implants; dentistry; immediate dental implant loading; implant-supported dental prosthesis; mouth rehabilitation; oral health; orofacial cleft; quality of life; rehabilitation research; treatment outcome.

Figure 1

Summary of the research methodology. CBCT: cone beam computed tomography; IOPAR: intraoral periapical radiograph; ISQ: implant stability quotient; OHI-S: Oral Hygiene Index – Simplified; OPG: orthopantogram; QoL: quality of life; SABG: secondary alveolar bone grafting.