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CompletedNCT05756946Updated Jul 20, 2023

Guided Tissue Regeneration With a Periodontal Dressing

An interventional study of periodontal dressing (coe-pak) and Guided Tissue Regeneration in Periodontal Diseases, sponsored by Arab American University (Palestine). Completed at 1 site in Palestinian Territory, occupied. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-20.

Sponsored by Arab American University (Palestine) · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Periodontal Diseases

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03

In context

Periodontal Diseases

830 studies on the registry are indexed under Periodontal Diseases; 188 are open to participants now.

This study's enrollment of 24 is below the median of 45 across 530 interventional studies indexed under Periodontal Diseases.

Browse Periodontal Diseases studies →

Lead sponsor

Arab American University (Palestine) is the lead sponsor of 12 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts 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

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).
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    Test group

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

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

  • Active comparator
    Control group

    Control group will receive GTR only

    Procedure: Guided Tissue Regeneration

Interventions

  • Procedureperiodontal dressing (coe-pak)

    Guided tissue regeneration and periodontal dressing

  • ProcedureGuided Tissue Regeneration

    Regeneration of lost periodontal tissues

    Also known as: GTR

06

What researchers measure

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

    Time frame: 14 days

Secondary outcomes

  1. Probing pocket depth

    changes in periodontal probing pocket depth in mm

    Time frame: 6 months

  2. Attachment level

    changes in clinical attachment level in mm

    Time frame: 6 months

07

Study locations

1 site
  • Mahmoud Abu-Ta'a
    Ramallah, Palestinian Territory, occupied
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 20, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05756946
Lead sponsor
Arab American University (Palestine)
Responsible party
Mahmoud Abu-Ta'a (Associate Professor, Arab American University (Palestine)) — Principal investigator
First posted
Mar 7, 2023
Start date
Mar 1, 2023
Primary completion
Apr 10, 2023
Completion
Apr 15, 2023
Last update
Jul 20, 2023

Study contacts

Mahmoud Abu-Ta'a
principal investigator · Department of Dental sciences, Faculty of Graduate Studies, Arab American University (AAUP)

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.

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