Minimally Invasive Non Surgical Therapy Versus Conventional Scaling and Root Planing for Treatment of Periodontitis

Not Applicable

Completed

• Conditions: Periodontal Diseases
• Interventions: Procedure: MINST; Procedure: Conventional SRP

• Registration Number: NCT04036513
• Lead Sponsor: University of Ljubljana

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-02
• Study First Submitted: 2019-07-25
• Study First Submitted QC: 2019-07-26
• Study First Posted: 2019-07-29
• Status Verified: 2021-04
• Primary Completion: 2021-04-02
• Study Completion: 2021-04-02
• Last Update Submitted: 2021-04-28
• Last Update Posted: 2021-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MINST	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.
Conventional SRP	Conventional SRP	Conventional non-surgical mechanical treatment using piezoelectric device (PiezoLED, Kavo) and standard Gracey curettes under local anaesthesia.

Primary Outcome Measures

Name	Time	Method
Number of diseased sites	3 months, 6 months, 12 months	Difference in No of Sites with PPD (probing pocket depth) \> 4 mm and BOP (bleeding upon probing)

Secondary Outcome Measures

Name	Time	Method
CAL	3 months, 6 months, 12 months	Clinical attachment loss
PPD	3 months, 6 months, 12 months	Average probing pocket depth
REC	3 months, 6 months, 12 months	Gingival recession
VOL	1 week, 1 month, 3 months, 6 months, 12 months	Volumetric 3D differences evaluated by optical scanning

Trial Locations

Locations (1)

Faculty of Medicine; 🇸🇮 Ljubljana, Slovenia