Periodontal Changes Following Mid Maxillary Distraction

Study Overview
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Brief Summary
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To evaluate the health status of the periodontium and dentition at the distraction osteogenesis site in CLP subjects using mid maxillary distraction (MMD).

Detailed Description
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Segmental forward maxillary distraction osteogenesis(DO)was performed. Distractor connecting buccal molar segments to the anterior maxilla was kept for 7 days. Then distraction was performed till overcorrection and consolidated for 3-months. Periodontal clinical parameters were recorded at baseline, 3 and 6-months postoperatively. Gingival crevicular fluid was collected . Soft tissue healing was evaluated clinically and histologically after distraction.

Official Title
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Periodontal Changes and Gingival Soft Tissue Healing Following Mid Maxillary Distraction in Cleft Lip and Palate Patients

Conditions
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Cleft Lip and Palate, Periodontal Pocket, Attachment Loss, Periodontal

Intervention / Treatment
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* Procedure: A Involvement with the osteotomy site of the surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Severe maxillary hypoplasia and negative anterior overjet Exclusion Criteria: Systemic disease

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Surgical distraction was performed in 20 cleft lip and palate (CLP) subjects with class III malocclusion, gingival GCF were collected from teeth neighboring the osteotomy site and from premolars of the opposite arch as control.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study<br>A Involvement with the osteotomy site of the surgery, osteotomy was performed then GCF were collected from teeth neighboring the | Procedure: A Involvement with the osteotomy site of the surgery<br>* A Involvement with the osteotomy site of the surgery<br>|
| Active Comparator: Control<br>Involvement with the osteotomy site of the surgery, surgical osteotomy was performed then GCF were collected from teeth away from the osteotomy site | Procedure: A Involvement with the osteotomy site of the surgery<br>* A Involvement with the osteotomy site of the surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of periodontal inflammatory mediators | periodontal inflammatory mediators IL-1β | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of periodontal inflammatory mediators TNF- α | periodontal inflammatory mediators TNF- α | 7 days | 
| Assessment of periodontal probing depth | probing depth measurement | 3 and 6 month | 
| Assessment of clinical attachment loss | clinical attachment loss measurement | 3 and 6 month | 
| Assessment of periodontal clinical parameters | Gingival index evaluation GI | 3 and 6 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Inflammation, Healing, Distraction, Periodontium