NCT05756946

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 15, 2023

Completed
14 days until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 7, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2023

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2023

Completed
Last Updated

July 20, 2023

Status Verified

July 1, 2023

Enrollment Period

1 month

First QC Date

February 15, 2023

Last Update Submit

July 19, 2023

Conditions

Periodontal Diseases

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Probing pocket depth

    6 months

  • Attachment level

    6 months

Study Arms (2)

Test group

EXPERIMENTAL

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

Procedure: periodontal dressing (coe-pak)Procedure: Guided Tissue Regeneration

Control group

ACTIVE COMPARATOR

Control group will receive GTR only

Procedure: Guided Tissue Regeneration

Interventions

periodontal dressing (coe-pak)PROCEDURE

Guided tissue regeneration and periodontal dressing

Test group
Guided Tissue RegenerationPROCEDURE

Regeneration of lost periodontal tissues

Also known as: GTR
Control groupTest group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mahmoud Abu-Ta'a

Ramallah, Palestinian Territories

Location

MeSH Terms

Conditions

Periodontal Diseases

Interventions

Periodontal DressingsCoe-PakGuided Tissue Regeneration

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

PeriodonticsDentistryPlastic Surgery ProceduresSurgical Procedures, Operative

Study Officials

  • Mahmoud Abu-Ta'a

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 15, 2023

First Posted

March 7, 2023

Study Start

March 1, 2023

Primary Completion

April 10, 2023

Study Completion

April 15, 2023

Last Updated

July 20, 2023

Record last verified: 2023-07

Locations

PA(1)