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Flapless Emdogain in the Treatment of Periodontal Residual Pockets

Primary Purpose

Chronic Periodontitis, Generalized

Status
Completed
Phase
Not Applicable
Locations
Palestinian Territory, occupied
Study Type
Interventional
Intervention
Re-instrumentation with flapless Emdogain application
Re-instrumentation with placebo application
Sponsored by
Arab American University (Palestine)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Periodontitis, Generalized

Eligibility Criteria

19 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Arab American University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Flapless Emdogain (FEMD) group

Placebo group

Arm Description

Re-instrumentation with flapless emdogain application

Re-instrumentation without flapless emdogain application

Outcomes

Primary Outcome Measures

Differences in changes of probing pocket depths (PPD) from baseline to 6 and 12 months
probing pocket depth (PPD)
Differences in changes of bleeding on probing (BOP) from baseline to 6 and 12 months
bleeding on probing (BOP)

Secondary Outcome Measures

frequencies of pocket closure
PPD ≤4 mm

Full Information

First Posted
April 7, 2023
Last Updated
April 19, 2023
Sponsor
Arab American University (Palestine)
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1. Study Identification

Unique Protocol Identification Number
NCT05823389
Brief Title
Flapless Emdogain in the Treatment of Periodontal Residual Pockets
Official Title
The Use of Flapless Enamel Matrix Derivative in Treating Periodontal Residual Pockets: A Single-centre Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
September 2, 2019 (Actual)
Primary Completion Date
October 1, 2022 (Actual)
Study Completion Date
December 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Arab American University (Palestine)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Periodontitis, Generalized

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Flapless Emdogain (FEMD) group
Arm Type
Experimental
Arm Description
Re-instrumentation with flapless emdogain application
Arm Title
Placebo group
Arm Type
Active Comparator
Arm Description
Re-instrumentation without flapless emdogain application
Intervention Type
Procedure
Intervention Name(s)
Re-instrumentation with flapless Emdogain application
Intervention Description
Teeth with deep probing pocket depths were randomized to receive re-instrumentation with adjunctive flapless administration of EMD
Intervention Type
Procedure
Intervention Name(s)
Re-instrumentation with placebo application
Intervention Description
Teeth with deep probing pocket depths were randomized to receive re-instrumentation with adjunctive placebo application
Primary Outcome Measure Information:
Title
Differences in changes of probing pocket depths (PPD) from baseline to 6 and 12 months
Description
probing pocket depth (PPD)
Time Frame
12 months
Title
Differences in changes of bleeding on probing (BOP) from baseline to 6 and 12 months
Description
bleeding on probing (BOP)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
frequencies of pocket closure
Description
PPD ≤4 mm
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Arab American University
City
Ramallah
ZIP/Postal Code
240
Country
Palestinian Territory, occupied

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Flapless Emdogain in the Treatment of Periodontal Residual Pockets

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