About this trial
This study is consisted of two arms. At first, a randomized controlled clinical trial will be conducted. Eighty systematically healthy, non-smoker patients with Periodontitis stage III or IV, grades B to C will be included. Each patient will have to present one intrabony defect site ( site with Probing Depth (PD)\>5mm and radiographic defect depth \> or =3mm). The patients will be randomized in two groups, regarding the treatment intervention of the intrabony defects: Group A (conventional Non-Surgical Periodontal Treatment, cNSPT) and Group B (Minimally Invasive Non-Surgical Therapy, MINST). At 5 days and 3 months following intervention, GCF samples will be collected from the intrabony defects in order to assess the molecular healing patterns through intergroup comparisons of inflammation and healing biomarkers. Then two prospective cohort studies will be conducted. The Group B patients will be matched with forty systematically healthy, smoker patients (Group C) with Periodontitis stage III or IV, grades B to C with each one presenting one intrabony defect site ( site with Probing Depth (PD)\>5mm and radiographic defect depth \> or =3mm). Then MINST will be performed in the patients of Group C and the two groups will be compared regarding the clinical and radiographic data obtained by clinical and radiographic examinations performed in both groups' intrabony defects pre-treatment and 6 months following the intervention (first prospective study) and regarding the differences in regeneration biomarkers in GCF samples obtained from the intrabony defects 5 days and 3 months post-treatment (second prospective study).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
patients with Periodontitis stage III or IV, grades B to C . Each patient will have to present one intrabony defect site ( site with Probing Depth (PD)>5mm and radiographic defect depth >3mm).
participants should be free of any systemic or oral conditions that could affect disease progression or treatment outcomes
Disqualifiers
diabetes
hepatic or renal disease
history of conditions requiring prophylactic antibiotics
anti-inflammatory or anticoagulant therapy the preceding month
Trial design
Parallel
Treatments tested in this trial
Minimally Invasive Non- Surgical Periodontal Therapy (MINST)
Procedure/SurgeryThe procedure consists of thorough debridement of the root surface through a subpapillary access using exclusively piezoelectric devices with specific thin and delicate tips (EMS, Switzerland) and 4X magnification loupes, taking care to minimize the soft tissue trauma and to stimulate the formation of a stable blood clot
conventional Non-Surgical Periodontal Treatment (cNSPT)
Procedure/SurgeryThe intervention consists of thorough debridement of the root surface under local anaesthesia, using conventional piezoelectric devices and hand instruments
Treatment groups
Trial outcomes
Primary outcomes
Concentrations of GCF inflammation and regeneration biomarkers.
Concentrations will be measured in pg/ml
Total amounts of GCF inflammation and regeneration biomarkers
Total amounts will be measured in pg/30 s
Secondary outcomes
Plaque index (PI)
Recorded in a dichotomous manner (+ or -) using a UNC-15 periodontal probe
Gingival index (GI)
Recorded in a dichotomous manner (+ or -) using a UNC-15 periodontal probe
Bleeding on probing (BoP)
Recorded in a dichotomous manner (+ or -) using a UNC-15 periodontal probe
Probing depth (PD)
Measured in mm using a UNC-15 periodontal probe
Locations
Sponsors and contacts
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University of Turku
Lead sponsor
251 Hellenic Air Force & VA General Hospital
Collaborator
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