Guided Tissue Regeneration With a Periodontal Dressing

Periodontal Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05756946
• Other study ID #: GTR
• Status: Completed
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: April 15, 2023

Study information

• Verified date: July 2023
• Source: Arab American University (Palestine)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: April 15, 2023
• Est. primary completion date: April 10, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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).

Related Conditions & MeSH terms

• Periodontal Diseases

Intervention

Procedure:
• periodontal dressing (coe-pak)
Guided tissue regeneration and periodontal dressing
• Guided Tissue Regeneration
Regeneration of lost periodontal tissues

Locations

Country	Name	City	State
Palestinian Territory, occupied	Mahmoud Abu-Ta'a	Ramallah

Sponsors (1)

Lead Sponsor	Collaborator
Arab American University (Palestine)

Country where clinical trial is conducted

Palestinian Territory, occupied, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Probing pocket depth	changes in periodontal probing pocket depth in mm	6 months
Secondary	Attachment level	changes in clinical attachment level in mm	6 months