Alveolar Cleft, Distraction of Bone
Conditions
Keywords
Alveolar Cleft, Bone Distraction
Brief summary
The study aimed to determine efficiency of Bone-Born Intraoral Distractor on wide Alveolar cleft patients
Detailed description
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
Interventions
DEVICEBone-borne Intra oral distractor
Evaluation of the efficiency of the Bone-Borne Intraoral distractors on wide Alveolar cleft
Sponsors
Faculty of Dental Medicine for Girls
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
This wasn't applicable during surgery and follow-up
Intervention model description
stereographic models were used for construction of bone-borne custom-made intraoral distractor
Eligibility
Sex/Gender
ALL
Age
7 Years to 20 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 6 months postoperative follow up | 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. |
| Change in tooth mobility assessed using Miller's Tooth Mobility Index (minimum score: 0; maximum score: 3; higher scores indicate worse mobility) | 6 months postoperative follow up | Tooth mobility will be clinically evaluated using Miller's Tooth Mobility Index to detect and grade the degree of mobility before and after treatment. |
| 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) | 6 months follow up | 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. |
Countries
Egypt
Outcome results
None listed