Guided Tissue Regeneration With a Periodontal Dressing

July 19, 2023 updated by: Mahmoud Abu-Ta'a, Arab American University (Palestine)

Guided Tissue Regeneration Combined With Periodontal Dressing: A Randomized Controlled Clinical Trial for the Treatment of Periodontal Defects

This randomized, controlled split-mouth study will include 24-40 patients. After GTR, a test and a control side will be selected by means of a computer-generated randomization list. Test sides will receive a periodontal dressing (Coepak") for 14 days and the control sides will receive no periodontal dressing. After 14 days the periodontal dressing will be removed and the pain experience will be recorded. After 6-9 months, the clinical periodontal parameters will be recorded.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

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

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

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age between 18 and 75 years.

    • A minimum of 18 teeth, wisdom teeth excluded.
    • Previously untreated moderate chronic periodontitis (Armitage 1999) with radiographic evidence of generalized alveolar bone loss >30%.
    • Presence of at least one pocket with probing pocket depth (PPD) ≥6 mm per quadrant, which was BOP.
    • Presence of at least three teeth per quadrant.

Exclusion Criteria:

  • Periodontal treatment in the last 3 years.

    • Antibiotic intake 6 months before • the screening visit.
    • Pregnancy. Systemic diseases with an impact on periodontal healing (e.g. Dia- betes).

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test group
Test group will receive GTR + periodontal dressing (Coe-pak)
Procedure: periodontal dressing (coe-pak)
Guided tissue regeneration and periodontal dressing
Procedure: Guided Tissue Regeneration
Regeneration of lost periodontal tissues
Other Names:
  • GTR
Active Comparator: Control group
Control group will receive GTR only
Procedure: Guided Tissue Regeneration
Regeneration of lost periodontal tissues
Other Names:
  • GTR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain experience
Time Frame: 14 days
pain experience will be measured 14 days after GTR procedure; when the dressing is removed. Participants have to fill a VAS score out about pain intensity on a scale from 0 to 10 (0 = no pain, 5 = moderate pain and 10 = worst imaginable pain) and the amount of pain medication taken will be recorded
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Probing pocket depth
Time Frame: 6 months
changes in periodontal probing pocket depth in mm
6 months
Attachment level
Time Frame: 6 months
changes in clinical attachment level in mm
6 months

Collaborators and Investigators

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

Sponsor

Arab American University (Palestine)

Investigators

  • Principal Investigator: Mahmoud Abu-Ta'a, Department of Dental sciences, Faculty of Graduate Studies, Arab American University (AAUP)

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)

March 1, 2023

Primary Completion (Actual)

April 10, 2023

Study Completion (Actual)

April 15, 2023

Study Registration Dates

First Submitted

February 15, 2023

First Submitted That Met QC Criteria

February 23, 2023

First Posted (Actual)

March 7, 2023

Study Record Updates

Last Update Posted (Actual)

July 20, 2023

Last Update Submitted That Met QC Criteria

July 19, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GTR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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