Back to resultsPeriodontal Changes Following Mid Maxillary Distraction
Primary Purpose
Cleft Lip and Palate, Periodontal Pocket, Attachment Loss, Periodontal
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
A Involvement with the osteotomy site of the surgery
Sponsored by
About this trial
This is an interventional treatment trial for Cleft Lip and Palate focused on measuring Inflammation, Healing, Distraction, Periodontium
Eligibility Criteria
Inclusion Criteria:
- Severe maxillary hypoplasia and negative anterior overjet
Exclusion Criteria:
- Systemic disease
Sites / Locations
- Faculty of Dentistry
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Study
Control
Arm Description
A Involvement with the osteotomy site of the surgery, osteotomy was performed then GCF were collected from teeth neighboring the
Involvement with the osteotomy site of the surgery, surgical osteotomy was performed then GCF were collected from teeth away from the osteotomy site
Outcomes
Primary Outcome Measures
Measurement of periodontal inflammatory mediators
periodontal inflammatory mediators IL-1β
Secondary Outcome Measures
Measurement of periodontal inflammatory mediators TNF- α
periodontal inflammatory mediators TNF- α
Assessment of periodontal probing depth
probing depth measurement
Assessment of clinical attachment loss
clinical attachment loss measurement
Assessment of periodontal clinical parameters
Gingival index evaluation GI
Full Information
NCT ID
NCT03686761
First Posted
September 25, 2018
Last Updated
September 29, 2018
Sponsor
University of Alexandria
Collaborators
Alexandria University
1. Study Identification
Unique Protocol Identification Number
NCT03686761
Brief Title
Periodontal Changes Following Mid Maxillary Distraction
Official Title
Periodontal Changes and Gingival Soft Tissue Healing Following Mid Maxillary Distraction in Cleft Lip and Palate Patients
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
February 2015 (Actual)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
October 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alexandria
Collaborators
Alexandria University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cleft Lip and Palate, Periodontal Pocket, Attachment Loss, Periodontal
Keywords
Inflammation, Healing, Distraction, Periodontium
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Surgical distraction was performed in 20 cleft lip and palate (CLP) subjects with class III malocclusion, gingival GCF were collected from teeth neighboring the osteotomy site and from premolars of the opposite arch as control.
Masking
None (Open Label)
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
Allocation
Non-Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Study
Arm Type
Experimental
Arm Description
A Involvement with the osteotomy site of the surgery, osteotomy was performed then GCF were collected from teeth neighboring the
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Involvement with the osteotomy site of the surgery, surgical osteotomy was performed then GCF were collected from teeth away from the osteotomy site
Intervention Type
Procedure
Intervention Name(s)
A Involvement with the osteotomy site of the surgery
Intervention Description
A Involvement with the osteotomy site of the surgery
Primary Outcome Measure Information:
Title
Measurement of periodontal inflammatory mediators
Description
periodontal inflammatory mediators IL-1β
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Measurement of periodontal inflammatory mediators TNF- α
Description
periodontal inflammatory mediators TNF- α
Time Frame
7 days
Title
Assessment of periodontal probing depth
Description
probing depth measurement
Time Frame
3 and 6 month
Title
Assessment of clinical attachment loss
Description
clinical attachment loss measurement
Time Frame
3 and 6 month
Title
Assessment of periodontal clinical parameters
Description
Gingival index evaluation GI
Time Frame
3 and 6 month
Other Pre-specified Outcome Measures:
Title
Evaluating the gingival histological changes
Description
histological examination of the soft tissue
Time Frame
2 and 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Severe maxillary hypoplasia and negative anterior overjet
Exclusion Criteria:
Systemic disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marwa Madi
Organizational Affiliation
Alexandria University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Dentistry
City
Alexandria
ZIP/Postal Code
21221
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Periodontal Changes Following Mid Maxillary Distraction
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