Abstract
BackgroundOrofacial 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.ObjectiveThis 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.MethodsPatients 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.ResultsA 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.ConclusionsThis 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 RegistrationClinical Trial Registry of India CTRI/2020/09/027997; http://ctri.nic.in/Clinicaltrials/showallp.php?mid1=47659&EncHid=&userName=dental%20implantsInternational Registered Report Identifier (IRRID)PRR1-10.2196/25244
Highlights
BackgroundOrofacial cleft is the most common congenital anomaly, with an incidence of 1 in 700 to 1 in 1000 live births across different populations [1]
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
A total of 30 dental implants will be placed in patients with a nonsyndromic orofacial cleft
Summary
Orofacial cleft is the most common congenital anomaly, with an incidence of 1 in 700 to 1 in 1000 live births across different populations [1]. Tooth agenesis affecting the maxillary lateral incisor in the cleft region is the most commonly found anomaly followed by crowding and delayed development [4,5]. All of these defects in cumulation compromise the patient’s quality of life, and each case poses a challenge for the multidisciplinary health care team due to the unique presentation. 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. The most recent decade has seen increasing use of dental implants in the cleft region; the outcome of an immediately loaded dental implant is still elusive for orofacial cleft patients
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