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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Periodontitis
• Intervention / Treatment: Procedure: Non-surgical periodontal treatment; Device: Enamel matrix derivate

Detailed Description

Phase 1: Screening After written informed consent has been obtained, the patient is entered in the screening and enrolment log and in the patient identification log and receives a patient identification number. An evaluation is then carried out by a periodontist with a dental hygienist to determine whether the patient meets the study inclusion criteria and none of the exclusion criteria and study specific information will be collected. For excluded patients, the reason(s) for exclusion shall be documented.

Phase 2: Treatment After providing informed consent, screening completion and after examination by a periodontist, study treatment will be performed only once the Plaque Index (PI) of each screened patient will be <20%. This means that randomization and the scaling phase (study treatment) will be only initiated when each individual patient was compliant with the oral hygiene instructions and the PI (as measured with Staining rondells red Directa, 4 surface plaque index, 1 rinsing 10 sec with 50 ml of water) was recorded to be <20%.

Randomization to test or control-quadrants will be performed using statistical software after full mouth scaling and root planing has taken place. Out of the four quadrants / patient, two quadrants will be randomised to be treated according to standard care with adjunctive Emdogain® FL. The remaining two quadrants will be treated as controls (standard care; no adjunctive Emdogain® FL).

Following randomization, root planing and scaling will be performed by a calibrated dental hygienist in all quadrants under local anaesthesia (with xylocaine adrenaline 2%). First, an ultrasonic scaler (EMS) will be used and then manual scaling with LM-curettes will be performed. The hygienist will scale each root surface until the root surface is judged to be free of tartar. As part of standard care, this decision is made by the calibrated dental hygienist based on tactile experience.

Pockets of 5mm to 9mm (PPD) will be treated in the study (both Test and Control treatment). Test treatment: Emdogain® FL will be added to standard treatment i. e. Test quadrants. PrefGel® will be applied on the root surface for 2 minutes, then rinsed away with sterile saline solution for 30 seconds. The surface will be lightly dried using gauze and airblow and then Emdogain® will be applied. The Emdogain® FL application will be performed by the dental hygienist under the supervision of a periodontist. Control treatment: pockets of 5mm to 9mm (PPD) will receive standard treatment (no addition of Emdogain® FL) i. e. Control quadrants.

Additional teeth with PPD outside the range of 5mm to 9mm (PPD) may be present both in Test and/or Control quadrants. Such teeth will be treated using standard care (no Emdogain®) but they will not be included in study evaluations.

The patient will then be asked to rinse daily with an antiseptic mouth rinse twice a day (FLUX-CHX chlorhexidine 0.12% solution) until 14 days following the treatment. Antibiotics (e.g. penicillin V) may also be used in the presence of suppuration. The patient will be instructed not to brush in the treated area for 7 days following the treatment. Then only gentle brushing on buccal and lingual tooth surfaces using the roll stroke method will be recommended. The patients will be instructed not to perform any sulcular or interdental brushing before 2 weeks following the treatment.

Followed by individually planed healing controls and oral hygiene controls. (the number of visits/follow-ups will be recorded and presented.

Phase 3: 6 months follow up Examination will be carried out by a periodontist (blinded) at the six months follow up visit. Examination consists of periodontal assessments i. e. PI, BoP and PPD.

Phase 4: 12 months follow up Examination will be carried out by a periodontist (blinded) at the 12 months follow up visit. Examination consists of periodontal assessments (PI, BoP, PPD) and X-rays.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shariel Sayardoust, PhD, DDS; Phone Number: +46 (0) 736564648; Email: shariel.sayardoust@regionostergotland.se
• Study Contact Backup: Name: Carin Starkhammar Johansson, PhD, DDS

Study Locations

• Sweden
  • Region Östergötland
    • Linköping, Region Östergötland, Sweden, 58185
      • Recruiting
      • Centre for Oral Rhabilitation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Procedure: Non-surgical periodontal treatment; No additional/adjunctive treatment with Emdogain; Other Names: Control- no adjunctive treatment
Experimental: Test-adjunctive treatment with Emdogain; The experimental arm is the two quadrants per patient assigned to be treated vid adjunctive Emdogain.	Procedure: Non-surgical periodontal treatment; No additional/adjunctive treatment with Emdogain; Other Names: Control- no adjunctive treatment; Device: Enamel matrix derivate; 'Applying Enamel matrix derivate in the periodontal pockets after completing the non-surgical periodontal treatment; Other Names: Emdogain

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of teeth which are indicated for surgery (PPD ≥ 6mm) at 12 months after treatment	Proportion of teeth with PPD ≥ 6mm at the 12 month follow up will be determined.	12 month after treatment
Changes in Proportion of sites with Bleeding on Probing (BoP)	BoP will be recorded. The presence or absence of BoP will be documented as a "yes" or "no" on 4 sites (mesial, buccal, distal, and palatal) around the tooth. The endpoint will be defined as the proportion of sites with BoP .	baseline (before treatment), at 6 month and 12 moth after treatment
Mean rAttanchment Level (rAL) changes per quadrant	Mesial and distal rAL will be recorded as the result of quantitative assessment of the standardized peri-apical / bite wing x-ray (by a qualified and validated blinded radiologist). For rAL assessment standardized peri-apical radiographs are taken at the time points listed in Table 2 i. e. at Visits 2 (after treatment) and 4 (12 months). Parallel technique will be used, with vertical bite wings for molars and premolars and peri-apical X-rays will be performed for incisors and canines.	baseline (before treatment), and 12 moth after treatment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in the PI (Plaque Index) at 6 months and 12 months after treatment	PI will be recorded . The presence of plaque will be documented as "yes" or "no" on four sites (mesial, buccal, distal and palatal) around the tooth. The endpoint will be calculated as proportion of surfaces with plaque.	baseline (before treatment), at 6 month and 12 moth after treatment

Collaborators and Investigators

• Sponsor: Ostergotland County Council, Sweden
• Collaborators: Region Jönköping County
• Investigators: Principal Investigator: Shariel Sayardoust, PhD, DDS, Ostergotland County Council, Sweden

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: September 30, 2023
• First Submitted That Met QC Criteria: September 30, 2023
• First Posted (Actual): October 6, 2023

Study Record Updates

• Last Update Posted (Actual): October 31, 2024
• Last Update Submitted That Met QC Criteria: October 29, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Periodontal treatment; non-surgical treatment; Periodontitis stage 3 and 4; Enamel matrix derivate; Emdogain flapless
• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontitis
• Other Study ID Numbers: EMDFL2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No