Guided Tissue Regeneration With a Periodontal Dressing

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05756946

Enrollment

Registered

2023-03-07

Start date

2023-03-01

Completion date

2023-04-15

Last updated

2023-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periodontal Diseases

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.

Interventions

PROCEDUREperiodontal dressing (coe-pak)

Guided tissue regeneration and periodontal dressing

PROCEDUREGuided Tissue Regeneration

Regeneration of lost periodontal tissues

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Yes

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).

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Probing pocket depth	6 months	changes in periodontal probing pocket depth in mm
Attachment level	6 months	changes in clinical attachment level in mm

Countries

Palestinian Territories

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026