Skip to main content
OpenTrials
Completed

NCT Number: NCT04036513

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Periodontal Diseases Mouth Diseases Periodontitis Stomatognathic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine

Ljubljana, 1000, Slovenia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MINST

Procedure

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.

Conventional SRP

Procedure

Scaling and root planing with conventional instruments.

Primary outcomes

  1. 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

  1. PPD

    Time frame: 3 months, 6 months, 12 months

    Average probing pocket depth

  2. CAL

    Time frame: 3 months, 6 months, 12 months

    Clinical attachment loss

  3. REC

    Time frame: 3 months, 6 months, 12 months

    Gingival recession

  4. VOL

    Time frame: 1 week, 1 month, 3 months, 6 months, 12 months

    Volumetric 3D differences evaluated by optical scanning

Sponsors and collaborators

Lead sponsor

University of Ljubljana

Other

Registry information

Official study title

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

Acronym: MINST

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jul 29, 2019
Registry last updated
Apr 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.