Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06070181

Effectiveness of Adjunctive Therapy of Emdogain®FL in Non-surgical Periodontal Treatment

Led by Ostergotland County Council, Sweden · Updated on 2024-10-31

150

Participants Needed

1

Research Sites

126 weeks

Total Duration

On this page

Sponsors

O

Ostergotland County Council, Sweden

Lead Sponsor

R

Region Jönköping County

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Effectiveness of Adjunctive Therapy of Emdogain®FL in Non-surgical Periodontal Treatment

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Over 18 years old
  • Diagnosed with stage 3 or 4 periodontitis
  • Have residual gum pockets with probing depths from 5mm to 9mm
  • No furcation involvement in the affected pockets
  • Adequate plaque control with plaque index below 20%
Not Eligible

You will not qualify if you...

  • Antibiotic treatment in the last 3 months
  • Subgingival scaling and root planing performed in the last 12 months
  • Contraindication for Emdogain4 use, including uncontrolled diabetes or other uncontrolled systemic diseases
  • Conditions or treatments that impair wound healing such as chronic high dose steroid therapy, bone metabolic diseases, radiation therapy, immunosuppressive therapy
  • Infections or vascular problems at the treatment site

AI-Screening

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Trial Site Locations

Total: 1 location

1

Centre for Oral Rhabilitation

Linköping, Region Östergötland, Sweden, 58185

Actively Recruiting

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Research Team

S

Shariel Sayardoust, PhD, DDS

CONTACT

C

Carin Starkhammar Johansson, PhD, DDS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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