Guided Tissue Regeneration With a Periodontal Dressing

NCT ID: NCT05756946

Last Updated: 2023-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-01

Study Completion Date

2023-04-15

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.

Detailed Description

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Conditions

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Periodontal Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Test group

Test group will receive GTR + periodontal dressing (Coe-pak)

Group Type EXPERIMENTAL

periodontal dressing (coe-pak)

Intervention Type PROCEDURE

Guided tissue regeneration and periodontal dressing

Guided Tissue Regeneration

Intervention Type PROCEDURE

Regeneration of lost periodontal tissues

Control group

Control group will receive GTR only

Group Type ACTIVE_COMPARATOR

Guided Tissue Regeneration

Intervention Type PROCEDURE

Regeneration of lost periodontal tissues

Interventions

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periodontal dressing (coe-pak)

Guided tissue regeneration and periodontal dressing

Intervention Type PROCEDURE

Guided Tissue Regeneration

Regeneration of lost periodontal tissues

Intervention Type PROCEDURE

Other Intervention Names

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GTR

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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Arab American University (Palestine)

OTHER

Sponsor Role lead

Responsible Party

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Mahmoud Abu-Ta'a

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mahmoud Abu-Ta'a

Role: PRINCIPAL_INVESTIGATOR

Department of Dental sciences, Faculty of Graduate Studies, Arab American University (AAUP)

Locations

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Mahmoud Abu-Ta'a

Ramallah, , Palestinian Territories

Site Status

Countries

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Palestinian Territories

Other Identifiers

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GTR

Identifier Type: -

Identifier Source: org_study_id

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