PeriodontitisNCT06070181
Effectiveness of Adjunctive Therapy of Emdogain®FL in Non-surgical Periodontal Treatment
A study testing Enamel matrix derivate and Non-surgical periodontal treatment in people with Periodontitis, run by Ostergotland County Council, Sweden at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periodontitis
- What is being tested?
- Enamel matrix derivate and Non-surgical periodontal treatment
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSweden
- Study dates
- 1 Mar 2024to 1 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Carin Starkhammar Johansson, PhD, DDS contact
Sweden1 site, 1 recruiting
- Recruiting
Centre for Oral Rhabilitation
Linköping, Region Östergötland, 58185
About this study
Official title: "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:
Read more
- 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.
Read the 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.
- Conditions
- Periodontitis
- Being tested
- Enamel matrix derivate, Non-surgical periodontal treatment
- Keywords
- non-surgical treatment, Periodontal treatment, Periodontitis stage 3 and 4, Enamel matrix derivate, Emdogain flapless
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enamel matrix derivateDevice
Also called Emdogain
'Applying Enamel matrix derivate in the periodontal pockets after completing the non-surgical periodontal treatment
Non-surgical periodontal treatmentProcedure or surgery
Also called Control- no adjunctive treatment
No additional/adjunctive treatment with Emdogain
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Enamel matrix derivate; Procedure: Non-surgical periodontal treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline (before treatment), at 6 month and 12 moth after treatment
Secondary outcomes (3)
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 .
Measured: 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.
Measured: baseline (before treatment), and 12 moth after treatment
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.
Measured: 12 month after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2023
- Study start1 Mar 2024
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ostergotland County Council, Sweden
- Sponsor type
- University, hospital or other
- Collaborators
- Region Jönköping County
- Responsible party
- Principal investigator, Shariel Sayardoust, Ostergotland County Council, Sweden
- Investigators
- Shariel Sayardoust, PhD, DDS, Principal investigator, Ostergotland County Council, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06070181
- Sponsor's protocol ID
- EMDFL2023
- Status last verified
- Oct 2024
- First submitted
- 30 Sep 2023
- Last updated
- 31 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Effectiveness of Emdogain® As an Adjunctive Therapy for Non-Surgical Periodontal Treatment- a Randomized, Controlled, Split-Mouth Design Multicenter Clinical Trial"
- ClinicalTrials.gov ID
- NCT06070181
- Acronym / sponsor ID
- EMDFL2023
- Conditions
- Periodontitis
- Keywords
- non-surgical treatment, Periodontal treatment, Periodontitis stage 3 and 4, Enamel matrix derivate, Emdogain flapless
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Ostergotland County Council, SwedenUniversity, hospital or other
- Collaborators
- Region Jönköping County
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 6 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control- no adjunctive treatment | Other | Procedure: Non-surgical periodontal treatmentOne 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. |
| Test-adjunctive treatment with Emdogain | Experimental | Device: Enamel matrix derivate, Procedure: Non-surgical periodontal treatmentThe experimental arm is the two quadrants per patient assigned to be treated vid adjunctive Emdogain. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enamel matrix derivateAlso: Emdogain'Applying Enamel matrix derivate in the periodontal pockets after completing the non-surgical periodontal treatment | Device | Test-adjunctive treatment with Emdogain |
| Non-surgical periodontal treatmentAlso: Control- no adjunctive treatmentNo additional/adjunctive treatment with Emdogain | Procedure or surgery | Control- no adjunctive treatment, Test-adjunctive treatment with Emdogain |
Primary outcome
Changes in Pocket Probing Depth (PPD)
Time frame: baseline (before treatment), at 6 month and 12 moth after treatment
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.
3 secondary outcomes
Changes in Proportion of sites with Bleeding on Probing (BoP)
Time frame: baseline (before treatment), at 6 month and 12 moth after treatment
Mean rAttanchment Level (rAL) changes per quadrant
Time frame: baseline (before treatment), and 12 moth after treatment
Proportion of teeth which are indicated for surgery (PPD ≥ 6mm) at 12 months after treatment
Time frame: 12 month after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carin Starkhammar Johansson, PhD, DDS contact
Shariel Sayardoust, PhD, DDS principal investigator
Ostergotland County Council, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enamel matrix derivate and Non-surgical periodontal treatment in people with Periodontitis, run by Ostergotland County Council, Sweden at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shariel Sayardoust, PhD, DDS (+46 (0) 736564648, shariel.sayardoust@regionostergotland.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Pocket Probing Depth (PPD) (time frame: baseline (before treatment), at 6 month and 12 moth after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2024.