Actively Recruiting
Effectiveness of Adjunctive Therapy of Emdogain®FL in Non-surgical Periodontal Treatment
Led by Ostergotland County Council, Sweden · Updated on 2024-10-31
150
Participants Needed
1
Research Sites
126 weeks
Total Duration
On this page
Sponsors
O
Ostergotland County Council, Sweden
Lead Sponsor
R
Region Jönköping County
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effectiveness of Adjunctive Therapy of Emdogain®FL in Non-surgical Periodontal Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Over 18 years old
- Diagnosed with stage 3 or 4 periodontitis
- Have residual gum pockets with probing depths from 5mm to 9mm
- No furcation involvement in the affected pockets
- Adequate plaque control with plaque index below 20%
You will not qualify if you...
- Antibiotic treatment in the last 3 months
- Subgingival scaling and root planing performed in the last 12 months
- Contraindication for Emdogain4 use, including uncontrolled diabetes or other uncontrolled systemic diseases
- Conditions or treatments that impair wound healing such as chronic high dose steroid therapy, bone metabolic diseases, radiation therapy, immunosuppressive therapy
- Infections or vascular problems at the treatment site
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Centre for Oral Rhabilitation
Linköping, Region Östergötland, Sweden, 58185
Actively Recruiting
Research Team
S
Shariel Sayardoust, PhD, DDS
CONTACT
C
Carin Starkhammar Johansson, PhD, DDS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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