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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03686761
Other study ID # 00010556
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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