Back to resultsGuided Tissue Regeneration With a Periodontal Dressing
Primary Purpose
Periodontal Diseases
Status
Completed
Phase
Not Applicable
Locations
Palestinian Territory, occupied
Study Type
Interventional
Intervention
periodontal dressing (coe-pak)
Guided Tissue Regeneration
Sponsored by
About this trial
This is an interventional supportive care trial for Periodontal Diseases
Eligibility Criteria
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).
Sites / Locations
- Mahmoud Abu-Ta'a
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Test group
Control group
Arm Description
Test group will receive GTR + periodontal dressing (Coe-pak)
Control group will receive GTR only
Outcomes
Primary Outcome Measures
Pain experience
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
Secondary Outcome Measures
Probing pocket depth
changes in periodontal probing pocket depth in mm
Attachment level
changes in clinical attachment level in mm
Full Information
NCT ID
NCT05756946
First Posted
February 15, 2023
Last Updated
July 19, 2023
Sponsor
Arab American University (Palestine)
1. Study Identification
Unique Protocol Identification Number
NCT05756946
Brief Title
Guided Tissue Regeneration With a Periodontal Dressing
Official Title
Guided Tissue Regeneration Combined With Periodontal Dressing: A Randomized Controlled Clinical Trial for the Treatment of Periodontal Defects
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
April 10, 2023 (Actual)
Study Completion Date
April 15, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Arab American University (Palestine)
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Diseases
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Test group
Arm Type
Experimental
Arm Description
Test group will receive GTR + periodontal dressing (Coe-pak)
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Control group will receive GTR only
Intervention Type
Procedure
Intervention Name(s)
periodontal dressing (coe-pak)
Intervention Description
Guided tissue regeneration and periodontal dressing
Intervention Type
Procedure
Intervention Name(s)
Guided Tissue Regeneration
Other Intervention Name(s)
GTR
Intervention Description
Regeneration of lost periodontal tissues
Primary Outcome Measure Information:
Title
Pain experience
Description
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
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Probing pocket depth
Description
changes in periodontal probing pocket depth in mm
Time Frame
6 months
Title
Attachment level
Description
changes in clinical attachment level in mm
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mahmoud Abu-Ta'a
Organizational Affiliation
Department of Dental sciences, Faculty of Graduate Studies, Arab American University (AAUP)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mahmoud Abu-Ta'a
City
Ramallah
Country
Palestinian Territory, occupied
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Guided Tissue Regeneration With a Periodontal Dressing
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