Flapless Emdogain in the Treatment of Periodontal Residual Pockets

Not Applicable

Completed

• Conditions: Chronic Periodontitis, Generalized
• Interventions: Procedure: Re-instrumentation with flapless Emdogain application; Procedure: Re-instrumentation with placebo application

• Registration Number: NCT05823389
• Lead Sponsor: Arab American University (Palestine)

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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-02
• Primary Completion: 2022-10-01
• Study Completion: 2022-12-15
• Status Verified: 2023-04
• Study First Submitted: 2023-04-07
• Study First Submitted QC: 2023-04-19
• Last Update Submitted: 2023-04-19
• Study First Posted: 2023-04-21
• Last Update Posted: 2023-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Flapless Emdogain (FEMD) group	Re-instrumentation with flapless Emdogain application	Re-instrumentation with flapless emdogain application
Placebo group	Re-instrumentation with placebo application	Re-instrumentation without flapless emdogain application

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
frequencies of pocket closure	12 months	PPD ≤4 mm

Trial Locations

Locations (1)

Arab American University; 🇵🇸 Ramallah, Palestinian Territory, occupied