Status:
RECRUITING
Effectiveness of Adjunctive Therapy of Emdogain®FL in Non-surgical Periodontal Treatment
Lead Sponsor:
Ostergotland County Council, Sweden
Collaborating Sponsors:
Region Jönköping County
Conditions:
Periodontitis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
Detailed Description
Phase 1: Screening After written informed consent has been obtained, the patient is entered in the screening and enrolment log and in the patient identification log and receives a patient identificati...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
March 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06070181
Start Date
March 1 2024
End Date
August 1 2026
Last Update
October 31 2024
Active Locations (1)
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1
Centre for Oral Rhabilitation
Linköping, Region Östergötland, Sweden, 58185