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

NCT06070181 | Recruiting DMC

• 1 other identifier: EMDFL2023
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontitis

Keywords

non-surgical treatment; Periodontal treatment; Periodontitis stage 3 and 4; Enamel matrix derivate; Emdogain flapless

Outcome Measures

Primary Outcomes (1)

• Changes in Pocket Probing Depth (PPD)

  The PPD will be measured around each tooth by recording the distance in millimeters (mm) from the gingival margin to the bottom of the pocket at 4 locations (mesial, buccal, distal, and palatal). The mean across all teeth within each quadrant will be determined.

  baseline (before treatment), at 6 month and 12 moth after treatment

Secondary Outcomes (3)

• Changes in Proportion of sites with Bleeding on Probing (BoP)

  baseline (before treatment), at 6 month and 12 moth after treatment

• Mean rAttanchment Level (rAL) changes per quadrant

  baseline (before treatment), and 12 moth after treatment

• Proportion of teeth which are indicated for surgery (PPD ≥ 6mm) at 12 months after treatment

  12 month after treatment

Other Outcomes (1)

• Changes in the PI (Plaque Index) at 6 months and 12 months after treatment

  baseline (before treatment), at 6 month and 12 moth after treatment

Study Arms (2)

Control- no adjunctive treatment

OTHER

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.

Procedure: Non-surgical periodontal treatment

Test-adjunctive treatment with Emdogain

EXPERIMENTAL

The experimental arm is the two quadrants per patient assigned to be treated vid adjunctive Emdogain.

Device: Enamel matrix derivate; Procedure: Non-surgical periodontal treatment

Interventions

Enamel matrix derivate DEVICE

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

Also known as: Emdogain

Test-adjunctive treatment with Emdogain

Non-surgical periodontal treatment PROCEDURE

No additional/adjunctive treatment with Emdogain

Also known as: Control- no adjunctive treatment

Control- no adjunctive treatment; Test-adjunctive treatment with Emdogain

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Ostergotland County Council, Sweden: lead
• Region Jönköping County: collaborator

Study Sites (1)

Centre for Oral Rhabilitation

Linköping, Region Östergötland, 58185, Sweden

RECRUITING

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Shariel Sayardoust, PhD, DDS

  Ostergotland County Council, Sweden

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shariel Sayardoust, PhD, DDS

CONTACT

+46 (0) 736564648; shariel.sayardoust@regionostergotland.se

Carin Starkhammar Johansson, PhD, DDS

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor and Senior Consultant in Periodontology

Study Record Dates

• First Submitted: September 30, 2023
• First Posted: October 6, 2023
• Study Start: March 1, 2024
• Primary Completion: March 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: October 31, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)