Effectiveness of Adjunctive Therapy of Emdogain®FL in Non-surgical Periodontal Treatment
Recruiting now · Not applicable
Conditions studied: Periodontitis
In brief
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.
Key facts
- Study ID
- NCT06070181
- Run by
- Ostergotland County Council, Sweden
- People needed
- 150
- Starts
- 2024-03-01
- Expected to finish
- 2026-08-01
- Last updated by the study team
- 2024-10-31
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Centre for Oral Rhabilitation — Linköping, Region Östergötland, Sweden (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.