NCT06070181 Effectiveness of Adjunctive Therapy of Emdogain®FL in Non-surgical Periodontal Treatment
| NCT ID | NCT06070181 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ostergotland County Council, Sweden |
| Condition | Periodontitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2024-03-01 |
| Primary Completion | 2026-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 150 participants in total. It began in 2024-03-01 with a primary completion date of 2026-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
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.
Contact & Investigator
Shariel Sayardoust, PhD, DDS
PRINCIPAL INVESTIGATOR
Ostergotland County Council, Sweden
Frequently Asked Questions
Who can join the NCT06070181 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Periodontitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06070181 currently recruiting?
Yes, NCT06070181 is actively recruiting participants. Contact the research team at shariel.sayardoust@regionostergotland.se for enrollment information.
Where is the NCT06070181 trial being conducted?
This trial is being conducted at Linköping, Sweden.
Who is sponsoring the NCT06070181 clinical trial?
NCT06070181 is sponsored by Ostergotland County Council, Sweden. The principal investigator is Shariel Sayardoust, PhD, DDS at Ostergotland County Council, Sweden. The trial plans to enroll 150 participants.