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

Arab American University (Palestine)1 site in 1 country24 target enrollmentMarch 1, 2023

ConditionsPeriodontal Diseases

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Periodontal Diseases
Sponsor: Arab American University (Palestine)
Enrollment: 24
Locations: 1
Primary Endpoint: Pain experience
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 1, 2023

End Date

April 15, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Arab American University (Palestine)

Responsible Party

Principal Investigator

Mahmoud Abu-Ta'a

Associate Professor

Arab American University (Palestine)

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).

Outcomes

Primary Outcomes

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