Guided Tissue Regeneration With a Periodontal Dressing

Not Applicable

Completed

• Conditions: Periodontal Diseases
• Interventions: Procedure: periodontal dressing (coe-pak); Procedure: Guided Tissue Regeneration

• Registration Number: NCT05756946
• Lead Sponsor: Arab American University (Palestine)

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-15
• Study First Submitted QC: 2023-02-23
• Study Start: 2023-03-01
• Study First Posted: 2023-03-07
• Primary Completion: 2023-04-10
• Study Completion: 2023-04-15
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-19
• Last Update Posted: 2023-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test group	periodontal dressing (coe-pak)	Test group will receive GTR + periodontal dressing (Coe-pak)
Control group	Guided Tissue Regeneration	Control group will receive GTR only
Test group	Guided Tissue Regeneration	Test group will receive GTR + periodontal dressing (Coe-pak)

Primary Outcome Measures

Name	Time	Method
Pain experience	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

Secondary Outcome Measures

Name	Time	Method
Probing pocket depth	6 months	changes in periodontal probing pocket depth in mm
Attachment level	6 months	changes in clinical attachment level in mm

Trial Locations

Locations (1)

Mahmoud Abu-Ta'a; 🇵🇸 Ramallah, Palestinian Territory, occupied