Accepted for/Published in: JMIR Research Protocols
Date Submitted: Oct 24, 2020
Date Accepted: Feb 24, 2021
Assessment of Outcomes of Immediately Loaded Dental Implants in Orofacial Cleft Patients: Protocol of a Single-Arm Clinical Trial
ABSTRACT
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. Clinical Trial: Clinical Trial Registry of India trial number CTRI/2020/09/027997; http://ctri.nic.in/Clinicaltrials/showallp.php?mid1=47659&EncHid=&userName=dental%20implants
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