Periodontal Changes Following Mid Maxillary Distraction

September 29, 2018 updated by: Marwa Ibrahim Madi, University of Alexandria

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

To evaluate the health status of the periodontium and dentition at the distraction osteogenesis site in CLP subjects using mid maxillary distraction (MMD).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Alexandria, Egypt, 21221
        • Faculty of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 25 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Severe maxillary hypoplasia and negative anterior overjet

Exclusion Criteria:

  • Systemic disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study
A Involvement with the osteotomy site of the surgery, osteotomy was performed then GCF were collected from teeth neighboring the
Procedure: A Involvement with the osteotomy site of the surgery
A Involvement with the osteotomy site of the surgery
Active Comparator: Control
Involvement with the osteotomy site of the surgery, surgical osteotomy was performed then GCF were collected from teeth away from the osteotomy site
Procedure: A Involvement with the osteotomy site of the surgery
A Involvement with the osteotomy site of the surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of periodontal inflammatory mediators
Time Frame: 7 days
periodontal inflammatory mediators IL-1β
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of periodontal inflammatory mediators TNF- α
Time Frame: 7 days
periodontal inflammatory mediators TNF- α
7 days
Assessment of periodontal probing depth
Time Frame: 3 and 6 month
probing depth measurement
3 and 6 month
Assessment of clinical attachment loss
Time Frame: 3 and 6 month
clinical attachment loss measurement
3 and 6 month
Assessment of periodontal clinical parameters
Time Frame: 3 and 6 month
Gingival index evaluation GI
3 and 6 month

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluating the gingival histological changes
Time Frame: 2 and 4 weeks
histological examination of the soft tissue
2 and 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alexandria

Collaborators

Alexandria University

Investigators

  • Principal Investigator: Marwa Madi, Alexandria University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2015

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

September 25, 2018

First Submitted That Met QC Criteria

September 25, 2018

First Posted (Actual)

September 27, 2018

Study Record Updates

Last Update Posted (Actual)

October 2, 2018

Last Update Submitted That Met QC Criteria

September 29, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00010556

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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