Split Mouth Comparison of Minimally Invasive Non Surgical Therapy Versus Conventional Scaling and Root Planing for Treatment of Periodontitis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Ljubljana
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Number of diseased sites
Study Overview
Brief Summary
Minimally invasive non-surgical therapy (MINST) is a new approach towards regeneration of deep periodontal defects. Important part of MINST procedure, besides usage of magnification loupes and piezo-electric devices seems to be the usage of special mini-curettes, originally mini-five and after mini-five of Hu-Friedy. So far only descriptive data about the clinical effects of such procedure are available and comparative studies that would include other treatment alternatives are lacking. Therefore, the aim of our study is, on split-mouth model, to compare the number of diseased sites (defined by probing depth ˃ 4 mm and bleeding on probing) after conventional non-surgical therapy and MINST with the usage of special mini-curettes. In addition, new 3D parameters obtained from 3D optical scanning will be developed for evaluation of volume changes of soft tissues.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Masking Description
Evaluator different to care provider
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •periodontitis Stage III, grade B/C
- •at least 20 teeth
- •at least 9 teeth (excluding molars) in the upper jaw
- •without FPD, implants
- •without occlusal trauma signs
- •no pathology of endodontic origin
- •without chronic systemic diseases
- •no periodontal treatment in the last 6 months
Exclusion Criteria
- •poor oral hygiene (PI > 20% at evaluation)
- •antibiotic treatment in the last 6 months or during the observation period
- •pregnant women, lactation, serious chronic systemic diseases, medication with known influence on periodontium or wound healing
Arms & Interventions
MINST
Usage of magnification loupes, specific thin and delicate tips together with piezoelectric device and specifically designed Hu-Friedy "mini five", "micro mini five", and "after five" Gracey curettes under local anaesthesia.
Intervention: MINST (Procedure)
Conventional SRP
Conventional non-surgical mechanical treatment using piezoelectric device (PiezoLED, Kavo) and standard Gracey curettes under local anaesthesia.
Intervention: Conventional SRP (Procedure)
Outcomes
Primary Outcomes
Number of diseased sites
Time Frame: 3 months, 6 months, 12 months
Difference in No of Sites with PPD (probing pocket depth) \> 4 mm and BOP (bleeding upon probing)
Secondary Outcomes
- CAL(3 months, 6 months, 12 months)
- PPD(3 months, 6 months, 12 months)
- REC(3 months, 6 months, 12 months)
- VOL(1 week, 1 month, 3 months, 6 months, 12 months)
Investigators
Rok Gašperšič
Assist. Prof.
University of Ljubljana