Periodontal Changes Following Mid Maxillary Distraction

Not Applicable

Completed

• Conditions: Periodontal Pocket; Cleft Lip and Palate; Attachment Loss, Periodontal
• Interventions: Procedure: A Involvement with the osteotomy site of the surgery

• Registration Number: NCT03686761
• Lead Sponsor: University of Alexandria

Brief Summary

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

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.

Study Timeline

• Study Start: 2015-02
• Primary Completion: 2016-09
• Study Completion: 2016-10
• Status Verified: 2018-09
• Study First Submitted: 2018-09-25
• Study First Submitted QC: 2018-09-25
• Study First Posted: 2018-09-27
• Last Update Submitted: 2018-09-29
• Last Update Posted: 2018-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Severe maxillary hypoplasia and negative anterior overjet

Exclusion Criteria

• Systemic disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Control	A Involvement with the osteotomy site of the surgery	Involvement with the osteotomy site of the surgery, surgical osteotomy was performed then GCF were collected from teeth away from the osteotomy site
Study	A Involvement with the osteotomy site of the surgery	A Involvement with the osteotomy site of the surgery, osteotomy was performed then GCF were collected from teeth neighboring the

Primary Outcome Measures

Name	Time	Method
Measurement of periodontal inflammatory mediators	7 days	periodontal inflammatory mediators IL-1β

Secondary Outcome Measures

Name	Time	Method
Assessment of clinical attachment loss	3 and 6 month	clinical attachment loss measurement
Measurement of periodontal inflammatory mediators TNF- α	7 days	periodontal inflammatory mediators TNF- α
Assessment of periodontal probing depth	3 and 6 month	probing depth measurement
Assessment of periodontal clinical parameters	3 and 6 month	Gingival index evaluation GI

Trial Locations

Locations (1)

Faculty of Dentistry; 🇪🇬 Alexandria, Egypt