Effectiveness of Emdogain® As an Adjunctive Therapy for Non-Surgical Periodontal Treatment- a Randomized, Controlled, Split-Mouth Design Multicenter Clinical Trial

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ 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.

⁃ 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

Locations
Other Locations
Sweden
Centre for Oral Rhabilitation
RECRUITING
Linköping
Contact Information
Primary
Shariel Sayardoust, PhD, DDS
shariel.sayardoust@regionostergotland.se
+46 (0) 736564648
Backup
Carin Starkhammar Johansson, PhD, DDS
Time Frame
Start Date: 2024-03-01
Estimated Completion Date: 2026-08-01
Participants
Target number of participants: 150
Treatments
Other: Control- no adjunctive treatment
One arm is the control: two quadrants per each patient treated with non-surgical periodontal treatment alone. NO adjunctive treatment with emdogain. The two quadrants are randomized.
Experimental: Test-adjunctive treatment with Emdogain
The experimental arm is the two quadrants per patient assigned to be treated vid adjunctive Emdogain.
Related Therapeutic Areas
Sponsors
Leads: Ostergotland County Council, Sweden
Collaborators: Region Jönköping County

This content was sourced from clinicaltrials.gov