Assessment of Outcomes of Immediately Loaded Dental Implants in Orofacial Cleft Patients: Protocol for a Single-Arm Clinical Trial
Bibliographic record
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.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.032 | 0.030 |
| Meta-epidemiology (narrow) | 0.006 | 0.003 |
| Meta-epidemiology (broad) | 0.010 | 0.005 |
| Bibliometrics | 0.002 | 0.002 |
| Science and technology studies | 0.003 | 0.004 |
| Scholarly communication | 0.003 | 0.003 |
| Open science | 0.004 | 0.002 |
| Research integrity | 0.010 | 0.007 |
| Insufficient payload (model declined to judge) | 0.040 | 0.009 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".