Periodontal Changes and Gingival Soft Tissue Healing Following Mid Maxillary Distraction in Cleft Lip and Palate Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Alexandria
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- Measurement of periodontal inflammatory mediators
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Masking Description
The clinical assessment was not masked , however, the histological and biomarker examination were send to blind investigator not directly involved in the study
Eligibility Criteria
- Ages
- 16 Years to 25 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Severe maxillary hypoplasia and negative anterior overjet
Exclusion Criteria
- •Systemic disease
Arms & Interventions
Study
A Involvement with the osteotomy site of the surgery, osteotomy was performed then GCF were collected from teeth neighboring the
Intervention: A Involvement with the osteotomy site of the surgery (Procedure)
Control
Involvement with the osteotomy site of the surgery, surgical osteotomy was performed then GCF were collected from teeth away from the osteotomy site
Intervention: A Involvement with the osteotomy site of the surgery (Procedure)
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)
Investigators
Marwa Ibrahim Madi
Principle investigator
University of Alexandria