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RECRUITING
NCT06070181
NA

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

Sponsor: Ostergotland County Council, Sweden

View on ClinicalTrials.gov

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.

Official title: "Effectiveness of Emdogain® As an Adjunctive Therapy for Non-Surgical Periodontal Treatment- a Randomized, Controlled, Split-Mouth Design Multicenter Clinical Trial"

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2024-03-01

Completion Date

2026-08-01

Last Updated

2024-10-31

Healthy Volunteers

No

Conditions

Interventions

DEVICE

Enamel matrix derivate

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

PROCEDURE

Non-surgical periodontal treatment

No additional/adjunctive treatment with Emdogain

Locations (1)

Centre for Oral Rhabilitation

Linköping, Region Östergötland, Sweden