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.
None
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
Parallel
Enamel matrix derivate
Device'Applying Enamel matrix derivate in the periodontal pockets after completing the non-surgical periodontal treatment
Non-surgical periodontal treatment
Procedure/SurgeryNo additional/adjunctive treatment with Emdogain
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.
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 .
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.
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.
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.
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Ostergotland County Council, Sweden
Lead sponsor
Region Jönköping County
Collaborator
