Status
Conditions
Treatments
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:
Participants in the study will undergo the following tasks:
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
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:
Exclusion criteria
Patients who meet any of the following exclusion criteria are not allowed to be included in the study:
Primary purpose
Allocation
Interventional model
Masking
150 participants in 2 patient groups
Loading...
Central trial contact
Shariel Sayardoust, PhD, DDS; Carin Starkhammar Johansson, PhD, DDS
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal