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Completed

NCT Number: NCT05756946

Guided Tissue Regeneration With a Periodontal Dressing

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.

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Key information

Conditions

Periodontal Diseases Mouth Diseases Stomatognathic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mahmoud Abu-Ta'a

Ramallah, Palestinian Territories

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

periodontal dressing (coe-pak)

Procedure

Guided tissue regeneration and periodontal dressing

Guided Tissue Regeneration

Procedure

Regeneration of lost periodontal tissues

Other names: GTR

Primary outcomes

  1. Pain experience

    Time frame: 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 outcomes

  1. Probing pocket depth

    Time frame: 6 months

    changes in periodontal probing pocket depth in mm

  2. Attachment level

    Time frame: 6 months

    changes in clinical attachment level in mm

Sponsors and collaborators

Lead sponsor

Arab American University (Palestine)

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 7, 2023
Registry last updated
Jul 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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