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

April 28, 2021 updated by: Rok Gašperšič, University of Ljubljana

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Slovenia
      • Ljubljana, Slovenia, 1000
        • Faculty of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Procedure: MINST
For reducing the need of surgical treatment in patients with chronic periodontal disease, we will use specifically designed Hu-Friedy curettes "mini five", "micro mini five" and "after five" together with piezoelectric device with thin and delicate tips that produce less periodontal trauma than usual Gracey curettes.
Active Comparator: Conventional SRP
Conventional non-surgical mechanical treatment using piezoelectric device (PiezoLED, Kavo) and standard Gracey curettes under local anaesthesia.
Procedure: Conventional SRP
Scaling and root planing with conventional instruments.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
3 months, 6 months, 12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Ljubljana

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 2, 2019

Primary Completion (Actual)

April 2, 2021

Study Completion (Actual)

April 2, 2021

Study Registration Dates

First Submitted

July 25, 2019

First Submitted That Met QC Criteria

July 26, 2019

First Posted (Actual)

July 29, 2019

Study Record Updates

Last Update Posted (Actual)

April 29, 2021

Last Update Submitted That Met QC Criteria

April 28, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-1-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Have no intention to share

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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