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
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 |
Verified date | September 2018 |
Source | Faculty of Medicine, University of Alexandria |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To evaluate the health status of the periodontium and dentition at the distraction osteogenesis site in CLP subjects using mid maxillary distraction (MMD).
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 |
Country | Name | City | State |
---|---|---|---|
Egypt | Faculty of Dentistry | Alexandria |
Lead Sponsor | Collaborator |
---|---|
Faculty of Medicine, University of Alexandria | Faculty of Dentistry, Alexandria University |
Egypt,
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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