Using Emdogain®FL to enhance non-surgical treatment for severe gum disease
"Effectiveness of Emdogain® As an Adjunctive Therapy for Non-Surgical Periodontal Treatment- a Randomized, Controlled, Split-Mouth Design Multicenter Clinical Trial"
NA · Ostergotland County Council, Sweden · NCT06070181
This study is testing if adding Emdogain® to regular gum disease treatment can help people with severe gum disease have less bleeding and need fewer surgeries.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ostergotland County Council, Sweden (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Linköping, Region Östergötland) |
| Trial ID | NCT06070181 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and effectiveness of Emdogain® therapy as an adjunct to non-surgical periodontal treatment for patients with stage 3 and 4 periodontitis. Participants will receive standard periodontal treatment along with Emdogain® in two quadrants of their mouth, while the other two quadrants will serve as controls. The study aims to determine if the addition of Emdogain® leads to better outcomes, such as reduced bleeding and probing pocket depth, as well as fewer teeth requiring surgery after 12 months. Follow-up assessments will occur at 6 and 12 months post-treatment.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with stage 3 or 4 periodontitis and probing depths between 5mm and 9mm.
Not a fit: Patients with uncontrolled systemic diseases or those who have had recent antibiotic treatment or scaling may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could lead to improved periodontal health and reduced need for surgical interventions in patients with severe gum disease.
How similar studies have performed: Previous studies have shown promising results with similar adjunctive therapies in periodontal treatment, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Linköping, Region Östergötland
- Centre for Oral Rhabilitation — Linköping, Region Östergötland, Sweden (RECRUITING)
Study contacts
- Principal investigator: Shariel Sayardoust, PhD, DDS — Ostergotland County Council, Sweden
- Study coordinator: Shariel Sayardoust, PhD, DDS
- Email: shariel.sayardoust@regionostergotland.se
- Phone: +46 (0) 736564648
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Periodontitis, non-surgical treatment, Periodontal treatment, Periodontitis stage 3 and 4, Enamel matrix derivate, Emdogain flapless