Periodontal Changes Following Mid Maxillary Distraction

Cleft Lip and Palate Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03686761
• Other study ID #: 00010556
• Status: Completed
• Phase: N/A
• Start date: February 2015
• Est. completion date: October 2016

Study information

• Verified date: September 2018
• Source: Faculty of Medicine, University of Alexandria
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 25 Years

Eligibility

Inclusion Criteria:

• Severe maxillary hypoplasia and negative anterior overjet

Exclusion Criteria:

• Systemic disease

Related Conditions & MeSH terms

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

Intervention

Procedure:
• A Involvement with the osteotomy site of the surgery
A Involvement with the osteotomy site of the surgery

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry	Alexandria

Sponsors (2)

Lead Sponsor	Collaborator
Faculty of Medicine, University of Alexandria	Faculty of Dentistry, Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Evaluating the gingival histological changes	histological examination of the soft tissue	2 and 4 weeks
Primary	Measurement of periodontal inflammatory mediators	periodontal inflammatory mediators IL-1ß	7 days
Secondary	Measurement of periodontal inflammatory mediators TNF- a	periodontal inflammatory mediators TNF- a	7 days
Secondary	Assessment of periodontal probing depth	probing depth measurement	3 and 6 month
Secondary	Assessment of clinical attachment loss	clinical attachment loss measurement	3 and 6 month
Secondary	Assessment of periodontal clinical parameters	Gingival index evaluation GI	3 and 6 month