Effectiveness of Adjunctive Therapy of Emdogain®FL in Non-surgical Periodontal Treatment
Launched by OSTERGOTLAND COUNTY COUNCIL, SWEDEN · Sep 30, 2023
Trial Information
Current as of June 19, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is exploring the use of a treatment called Emdogain® to see if it can improve the results of non-surgical treatment for patients with severe gum disease, specifically stage 3 and 4 periodontitis. The main focus is to find out if using Emdogain® alongside standard treatment can reduce gum bleeding and the depth of gum pockets more effectively than standard treatment alone. They will also check if this combination leads to better attachment of the gums to the teeth and if it reduces the need for surgery in the future.
To participate in the trial, you must be over 18 and have stage 3 or 4 periodontitis, with pockets in your gums between 5mm and 9mm deep. If you meet these criteria, you will receive standard non-surgical gum treatment and Emdogain® treatment in some areas, followed by check-ups at 6 and 12 months to monitor your progress. This study aims to gather important information about the safety and effectiveness of adding Emdogain® to your periodontal care, potentially helping many others with similar conditions in the future.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 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 Criteria:
- 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.
About Ostergotland County Council, Sweden
Östergötland County Council, located in Sweden, is a regional authority dedicated to advancing public health and medical research through the sponsorship of clinical trials. Committed to improving patient outcomes and fostering innovative healthcare solutions, the council collaborates with healthcare professionals, academic institutions, and research organizations. By facilitating rigorous clinical studies, Östergötland County Council aims to contribute to the development of evidence-based practices and enhance the quality of care provided to the community it serves.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Linköping, Region östergötland, Sweden
Patients applied
Trial Officials
Shariel Sayardoust, PhD, DDS
Principal Investigator
Ostergotland County Council, Sweden
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported