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Guided Tissue Regeneration With a Periodontal Dressing

Sponsor
Arab American University (Palestine) (Other)
Overall Status
Recruiting
CT.gov ID
NCT05756946
Collaborator
(none)
24
Enrollment
1
Location
2
Arms
3.6
Anticipated Duration (Months)
6.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: periodontal dressing (coe-pak)
  • Procedure: Guided Tissue Regeneration
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Supportive Care
Official Title:
Guided Tissue Regeneration Combined With Periodontal Dressing: A Randomized Controlled Clinical Trial for the Treatment of Periodontal Defects
Anticipated Study Start Date :
Mar 12, 2023
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Jul 1, 2023

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pain experience [14 days]

      pain experience will be measured 14 days after GTR procedure; when the dressing is removed. The participants have to fill out a pain intensity scale 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

    Secondary Outcome Measures

    1. Probing pocket depth [6 months]

      changes in periodontal probing pocket depth in mm

    2. Attachment level [6 months]

      changes in clinical attachment level in mm

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mahmoud Abu-Ta'a Ramallah Palestinian Territory, occupied

    Sponsors and Collaborators

    • Arab American University (Palestine)

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mahmoud Abu-Ta'a, Associate Professor, Arab American University (Palestine)
    ClinicalTrials.gov Identifier:
    NCT05756946
    Other Study ID Numbers:
    • GTR
    First Posted:
    Mar 7, 2023
    Last Update Posted:
    Mar 7, 2023
    Last Verified:
    Feb 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Periodontal Diseases

    Study Results

    No Results Posted as of Mar 7, 2023