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.
BACKGROUND
Orofacial cleft, one of the most common congenital deformity presents with a plethora of defects, subjecting the patient to multitude of treatments from a young age. Among the oral hard tissue problems, absence of 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 removable or fixed partial denture, however, the treatment modality does not meet patient expectations satisfactorily. 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
The presented protocol is of a single-arm clinical trial, aimed at determining the treatment outcome of immediately loaded dental implants in non-syndromic orofacial cleft patients.
METHODS
Patients meeting the set criteria will be sequentially enrolled till a sample size of 30 dental implants is met and will be subjected to the proposed treatment according to pre-decided protocol. All patients will be followed up at the designated time intervals for recording of various clinical and radiographic parameters. A quality of life assessment (QoL) questionnaire will also be recorded at the end of patient’s follow-up to know about their acceptance of the treatment.
RESULTS
A total of 30 dental implants will be placed in non-syndromic orofacial cleft patients in the cleft. Obtained results will be statistically analyzed to know the treatment outcomes and success.
CONCLUSIONS
This study would help in knowing 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.
CLINICALTRIAL
Clinical Trial Registry of India trial number CTRI/2020/09/027997; http://ctri.nic.in/Clinicaltrials/showallp.php?mid1=47659&EncHid=&userName=dental%20implants
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.