NCT06070181

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
Ostergotland County Council, Sweden·ClinicalTrials.gov·device·Device trialNot yet recruiting
View on ClinicalTrials.gov
Study focus
Disease/Condition
Periodontitis
Drug/Device/Intervention
Enamel matrix derivate
Study type
Interventional
Intervention type
device
Sponsor & location
Primary sponsor
Ostergotland County Council, Sweden
Timeline & enrollment
Phase
N/A
Start date
Dec 01, 2023
End date
Jun 01, 2026
Enrollment
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 periodontitisPeriodontosisAcute periodontitisChronic apical periodontitisPeriodontal disease, unspecified
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06070181
Type
Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.