Clinical Trial

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

Recruiting
View on ClinicalTrials.gov →
Record status
This record was last updated October 31, 2024 (before its estimated March 1, 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2023-09-30; most recent amendment 2024-10-29.
Status change: Not Yet Recruiting → Recruiting 2024-10-29
Trial Details
NCT Number NCT06070181
Lead Sponsor Ostergotland County Council, Sweden
Collaborators: Region Jönköping County
Conditions Periodontitis
Enrollment 150 participants
Start Date 2024-03-01
Primary Completion 2026-03-01 (estimated)
Study Completion 2026-08-01 (estimated)
Updated on ClinicalTrials.gov 2024-10-31