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Clinical Trials/NCT03686761
NCT03686761
Completed
Not Applicable

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

University of Alexandria1 site in 1 country20 target enrollmentFebruary 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cleft Lip and Palate
Sponsor
University of Alexandria
Enrollment
20
Locations
1
Primary Endpoint
Measurement of periodontal inflammatory mediators
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 2015
End Date
October 2016
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Marwa Ibrahim Madi

Principle investigator

University of Alexandria

Eligibility Criteria

Inclusion Criteria

  • Severe maxillary hypoplasia and negative anterior overjet

Exclusion Criteria

  • Systemic disease

Outcomes

Primary Outcomes

Measurement of periodontal inflammatory mediators

Time Frame: 7 days

periodontal inflammatory mediators IL-1β

Secondary Outcomes

  • Assessment of clinical attachment loss(3 and 6 month)
  • Measurement of periodontal inflammatory mediators TNF- α(7 days)
  • Assessment of periodontal probing depth(3 and 6 month)
  • Assessment of periodontal clinical parameters(3 and 6 month)

Study Sites (1)

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