Minimally Invasive Non- Surgical Periodontal Therapy of Intrabony Defects: Healing Patterns and Smoking Impact

ConditionPeriodontitis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of Turku

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Minimally Invasive Non- Surgical Periodontal Therapy (MINST)

    Procedure/Surgery

    The 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/Surgery

    The intervention consists of thorough debridement of the root surface under local anaesthesia, using conventional piezoelectric devices and hand instruments

Treatment groups

120 Participants
are divided into 3 treatment groups
Group A: Non-smokers cNSPTActive comparator 1 intervention
Group B: Non-smokers MINSTExperimental treatment 1 intervention
Group C: Smokers MINSTExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Concentrations of GCF inflammation and regeneration biomarkers.

Concentrations will be measured in pg/ml

Time frame
At 5 days and 3 months following intervention
2

Total amounts of GCF inflammation and regeneration biomarkers

Total amounts will be measured in pg/30 s

Time frame
At 5 days and 3 months following intervention

Secondary outcomes

1

Plaque index (PI)

Recorded in a dichotomous manner (+ or -) using a UNC-15 periodontal probe

Time frame
pre-treatment and 6 months following the intervention
2

Gingival index (GI)

Recorded in a dichotomous manner (+ or -) using a UNC-15 periodontal probe

Time frame
pre-treatment and 6 months following the intervention
3

Bleeding on probing (BoP)

Recorded in a dichotomous manner (+ or -) using a UNC-15 periodontal probe

Time frame
pre-treatment and 6 months following the intervention
4

Probing depth (PD)

Measured in mm using a UNC-15 periodontal probe

Time frame
pre-treatment and 6 months following the intervention

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Turku

Lead sponsor

251 Hellenic Air Force & VA General Hospital

Collaborator

This trial is not recruiting at the moment. You can still explore other options: