Flapless Emdogain in the Treatment of Periodontal Residual Pockets

April 19, 2023 updated by: Mahmoud Abu-Ta'a, Arab American University (Palestine)

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Flapless Emdogain (FEMD) group
Re-instrumentation with flapless emdogain application
Procedure: Re-instrumentation with flapless Emdogain application
Teeth with deep probing pocket depths were randomized to receive re-instrumentation with adjunctive flapless administration of EMD
Active Comparator: Placebo group
Re-instrumentation without flapless emdogain application
Procedure: Re-instrumentation with placebo application
Teeth with deep probing pocket depths were randomized to receive re-instrumentation with adjunctive placebo application

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differences in changes of probing pocket depths (PPD) from baseline to 6 and 12 months
Time Frame: 12 months
probing pocket depth (PPD)
12 months
Differences in changes of bleeding on probing (BOP) from baseline to 6 and 12 months
Time Frame: 12 months
bleeding on probing (BOP)
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
frequencies of pocket closure
Time Frame: 12 months
PPD ≤4 mm
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arab American University (Palestine)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 2, 2019

Primary Completion (Actual)

October 1, 2022

Study Completion (Actual)

December 15, 2022

Study Registration Dates

First Submitted

April 7, 2023

First Submitted That Met QC Criteria

April 19, 2023

First Posted (Actual)

April 21, 2023

Study Record Updates

Last Update Posted (Actual)

April 21, 2023

Last Update Submitted That Met QC Criteria

April 19, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EMD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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