Effectiveness of Adjunctive Therapy of Emdogain®FL in Non-surgical Periodontal Treatment

NCT06070181 · tracked via the Priya Life Science Sweden tracker

Sponsor

Ostergotland County Council, Sweden

Phase

Not applicable

Started

2024-03-01

Last updated

2024-10-31

Condition(s) studied

Periodontitis

Investigational drug(s) / intervention(s)

Enamel matrix derivateNon-surgical periodontal treatment

Enamel matrix derivate: 'Applying Enamel matrix derivate in the periodontal pockets after completing the non-surgical periodontal treatment

Non-surgical periodontal treatment: No additional/adjunctive treatment with Emdogain

Study summary

The goal of this clinical trial is to assess the safety and effectiveness of adjunctive Emdogain® therapy in non-surgical periodontal treatment for patients with stage 3 and 4 periodontitis.

The main questions it aims to answer are:

* Will adjunctive treatment with Emdogain® result in a greater reduction in Bleeding on Probing and probing pocket depth compared to non-surgical periodontal treatment alone? • Will adjunctive treatment with Emdogain® lead to a greater mean Radiographic attachment level (rAL) gain per quadrant compared to non-surgical periodontal treatment alone?
* Will adjunctive treatment with Emdogain® result in a lower proportion of treated teeth requiring surgery (PPD ≥6mm) at 12 months after treatment?

Participants in the study will undergo the following tasks:

* Screening and randomization
* Receival of non-surgical periodontal treatment in all quadrants and in two quadrants adjunctive Emdogain®
* 6-month follow-up assessment
* 12-month follow-up assessment

Clinical and radiological assesment will be performed in two quadrants treated with adjunctive Emdogain® therapy and two quadrants treated with non-surgical periodontal treatment alone. This comparison will help determine the effects of adjunctive therapy with Emdogain®.

The study aims to provide insights into the safety and efficacy of adjunctive Emdogain® therapy in non-surgical periodontal treatment, specifically in patients with stage 3 and 4 periodontitis.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: Study Population The study population will consist of patients affected by Stage 3 or 4 periodontitis. See below for a full list of inclusion and exclusion criteria. Inclusion Criteria Patients must meet all of the following criteria for inclusion in the study: * Over 18 years old * Stage 3 or 4 periodontitis * Residual pockets with probing depths from 5mm to 9mm with no furcation involvement and adequate plaque control Exclusion Criteria: Patients who meet any of the following exclusion criteria are not allowed to be included in the study: * Antibiotic treatment in last 3 months * Subgingival scaling and root planning performed in last 12 months * Patients for which the use of Emdogain® is contraindicated i. e. patients with uncontrolled diabetes or other uncontrolled systemic diseases, disorders or treatments that compromise wound healing, chronic high dose steroid therapy, bone metabolic diseases, radiation or other immuno-suppressive therapy and infections or vascular impairment at the surgical site.

Primary outcome measure(s)

Changes in Pocket Probing Depth (PPD) — baseline (before treatment), at 6 month and 12 moth after treatment
The PPD will be measured around each tooth by recording the distance in millimeters (mm) from the gingival margin to the bottom of the pocket at 4 locations (mesial, buccal, distal, and palatal). The mean across all teeth within each quadrant will be determined.

Trial sites (1)

Facility	City	Region	Status
Centre for Oral Rhabilitation	Linköping	Region Östergötland	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06070181 on ClinicalTrials.gov ↗ ← All trials in Sweden