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

NCT06070181 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2024-10-31

No results posted yet for this study

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.

Conditions

  • Periodontitis

Interventions

DEVICE

Enamel matrix derivate

'Applying Enamel matrix derivate in the periodontal pockets after completing the non-surgical periodontal treatment

PROCEDURE

Non-surgical periodontal treatment

No additional/adjunctive treatment with Emdogain

Sponsors & Collaborators

  • Region Jönköping County

    collaborator OTHER_GOV

  • Ostergotland County Council, Sweden

    lead OTHER

Principal Investigators

  • Shariel Sayardoust, PhD, DDS · Ostergotland County Council, Sweden

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-01
Primary Completion
2026-03-01
Completion
2026-08-01

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06070181 on ClinicalTrials.gov