Guided Tissue Regeneration With a Periodontal Dressing

Study Overview
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Brief Summary
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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.

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

Conditions
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Periodontal Diseases

Intervention / Treatment
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* Procedure: periodontal dressing (coe-pak)
* Procedure: Guided Tissue Regeneration


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 14 days | 

Secondary Outcome Measures

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