Evaluation of the Efficiency of Bone Born Intra Oral Distractor for Closure of Wide Alveolar Cleft

Faculty of Dental Medicine for Girls8 enrolled

Overview

The study aimed to determine efficiency of Bone-Born Intraoral Distractor on wide Alveolar cleft patients

Stereographic models were used for construction of bone-born custom-made intraoral distractor according to the inclusion and exclusion criteria, followed up to measure and determine the efficiency of the distractor

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Alveolar Cleft Distraction of Bone

Interventions

Bone-borne Intra oral distractorDEVICE

Evaluation of the efficiency of the Bone-Borne Intraoral distractors on wide Alveolar cleft

Eligibility

Sex: ALLMin age: 7 YearsMax age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with wide alveolar clefts more than 8ml either unilateral or bilateral or median facial cleft. * Patients who had previous failed grafting also may be included. * Age range of patients 7-20 years old, with no gender prediction, able to read and sign the informed consent (parents) * Patients with median facial clefts. Exclusion Criteria: * Narrow alveolar cleft * Syndromic patients. * Oral soft tissues defects, inflammation, infections and bone metabolism disturbance. * Allergy to titanium implant. * Patient with systemic disease and immunocompromised patient.

Locations (1)

Faculty of oral and dental medicine for Girls AlAzhar University

Cairo, Cairo Governorate, Egypt

Outcomes

Primary Outcomes

Change in alveolar cleft defect area measured by cone-beam computed tomography (CBCT) (minimum value: 0 mm²; no predefined maximum value; lower values indicate better outcome)

The alveolar cleft defect area will be quantitatively measured using cone-beam computed tomography (CBCT). Preoperative and postoperative CBCT scans will be superimposed to calculate the change in defect area following distraction osteogenesis.

Time frame: 6 months postoperative follow up

Change in tooth mobility assessed using Miller's Tooth Mobility Index (minimum score: 0; maximum score: 3; higher scores indicate worse mobility)

Tooth mobility will be clinically evaluated using Miller's Tooth Mobility Index to detect and grade the degree of mobility before and after treatment.

Time frame: 6 months postoperative follow up

Vitality of the transported bone segment assessed by clinical vitality indicators after transport distraction osteogenesis (binary outcome: viable / non-viable; viable outcome indicates better result)

Vitality of the transported disk after transport distraction osteogenesis is measured through clinical indicators as No infection, No pain or inflammation, Stable transported segment, Successful consolidation phase.

Time frame: 6 months follow up

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.