Flapless Emdogain in the Treatment of Periodontal Residual Pockets

Study Overview
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Brief Summary
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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

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

Conditions
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Chronic Periodontitis, Generalized

Intervention / Treatment
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* Procedure: Re-instrumentation with flapless Emdogain application
* Procedure: Re-instrumentation with placebo application


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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