Flapless Emdogain in the Treatment of Periodontal Residual Pockets

Sponsor

Arab American University (Palestine) (Other)

Overall Status

Completed

CT.gov ID

NCT05823389

Collaborator

(none)

Enrollment

Location

Arms

39.4

Actual Duration (Months)

1.2

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Chronic Periodontitis, Generalized	Procedure: Re-instrumentation with flapless Emdogain application Procedure: Re-instrumentation with placebo application	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

48 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 2, 2019

Actual Primary Completion Date :

Oct 1, 2022

Actual Study Completion Date :

Dec 15, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

frequencies of pocket closure [12 months]
PPD ≤4 mm

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arab American University	Ramallah		Palestinian Territory, occupied	240

Sponsors and Collaborators

Arab American University (Palestine)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mahmoud Abu-Ta'a, Associate Professor, Arab American University (Palestine)

ClinicalTrials.gov Identifier:

NCT05823389

Other Study ID Numbers:

First Posted:

Apr 21, 2023

Last Update Posted:

Apr 21, 2023

Last Verified:

Apr 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Periodontitis

Chronic Periodontitis

Study Results

No Results Posted as of Apr 21, 2023