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Effectiveness of Adjunctive Therapy of Emdogain®FL in Non-surgical Periodontal Treatment - Trial NCT06070181

Access comprehensive clinical trial information for NCT06070181 through Pure Global AI's free database. This phase not specified trial is sponsored by Ostergotland County Council, Sweden and is currently Not yet recruiting. The study focuses on Periodontitis. Target enrollment is 150 participants.

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Trial Details
ClinicalTrials.govNCT06070181
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Effectiveness of Adjunctive Therapy of Emdogain®FL in Non-surgical Periodontal Treatment
Effectiveness of Emdogain® as an Adjunctive Therapy for Non-Surgical Periodontal Treatment- A Randomized, Controlled, Split-Mouth Design Multicenter Clinical Trial

Study Focus

Periodontitis

Enamel matrix derivate

Interventional

device

Sponsor & Location

Ostergotland County Council, Sweden

Timeline & Enrollment

N/A

Dec 01, 2023

Jun 01, 2026

150 participants

Primary Outcome

Changes in Pocket Probing Depth (PPD)

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.

ICD-10 Classifications

Chronic periodontitis
Periodontosis
Acute periodontitis
Chronic apical periodontitis
Periodontal disease, unspecified

Data Source

ClinicalTrials.gov

NCT06070181

Device Trial