Skip to main content
OpenTrials
Completed

NCT Number: NCT05823389

Flapless Emdogain in the Treatment of Periodontal Residual Pockets

48 adult patients participated in a single-centre randomized clinical trial with split- mouth design. They had presented at re-evaluation after initial non-surgical periodontal therapy (steps 1 and 2 of periodontal therapy) for generalized periodontitis with at least 2 teeth with residual probing pocket depths (PPD) ≥5 and ≤8 mm, with bleeding on probing (BOP). Two teeth with similar PPD were randomized to receive re-instrumentation either with (test) or without (control) adjunctive flapless administration of EMD. Differences in the changes of PPD and BOP from baseline to 6 and 12 months will be analysed, and the frequencies of pocket closure (PPD ≤4 mm and no BOP) will be compared

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Periodontitis, Generalized Chronic Disease Chronic Periodontitis Disease Attributes Mouth Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Periodontal Diseases Periodontitis Stomatognathic Diseases

Age range

19 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arab American University

Ramallah, 240, Palestinian Territories

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • at least two residual pockets with probing pocket depth (PPD) ≥5 and ≤8 mm,
  • bleeding on probing (BOP),
  • mobility ≤degree 1 and
  • no furcation involvement.

Exclusion criteria

  • full mouth plaque score >20%,
  • uncontrolled systemic disease,
  • history of malignant disease in the oral cavity or previous radiotherapy in the head or neck area,
  • pregnant or lactating females,
  • drug and alcohol abuse,
  • smoking >10 cigarettes per day and
  • inadequate restorative therapy or malocclusion.

Treatment and study plan

Re-instrumentation with flapless Emdogain application

Procedure

Teeth with deep probing pocket depths were randomized to receive re-instrumentation with adjunctive flapless administration of EMD

Re-instrumentation with placebo application

Procedure

Teeth with deep probing pocket depths were randomized to receive re-instrumentation with adjunctive placebo application

Primary outcomes

  1. Differences in changes of probing pocket depths (PPD) from baseline to 6 and 12 months

    Time frame: 12 months

    probing pocket depth (PPD)

  2. Differences in changes of bleeding on probing (BOP) from baseline to 6 and 12 months

    Time frame: 12 months

    bleeding on probing (BOP)

Secondary outcomes

  1. frequencies of pocket closure

    Time frame: 12 months

    PPD ≤4 mm

Sponsors and collaborators

Lead sponsor

Arab American University (Palestine)

Other

Registry information

Official study title

The Use of Flapless Enamel Matrix Derivative in Treating Periodontal Residual Pockets: A Single-centre Randomized Clinical Trial

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Apr 21, 2023
Registry last updated
Apr 21, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.