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

Primary Purpose

Periodontal Diseases

Status
Completed
Phase
Not Applicable
Locations
Slovenia
Study Type
Interventional
Intervention
MINST
Conventional SRP
Sponsored by
University of Ljubljana
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontal Diseases focused on measuring Periodontitis, MINST, Scaling and root planing, Split mouth, 3D analysis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Faculty of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MINST

Conventional SRP

Arm Description

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 non-surgical mechanical treatment using piezoelectric device (PiezoLED, Kavo) and standard Gracey curettes under local anaesthesia.

Outcomes

Primary Outcome Measures

Number of diseased sites
Difference in No of Sites with PPD (probing pocket depth) > 4 mm and BOP (bleeding upon probing)

Secondary Outcome Measures

PPD
Average probing pocket depth
CAL
Clinical attachment loss
REC
Gingival recession
VOL
Volumetric 3D differences evaluated by optical scanning

Full Information

First Posted
July 25, 2019
Last Updated
April 28, 2021
Sponsor
University of Ljubljana
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1. Study Identification

Unique Protocol Identification Number
NCT04036513
Brief Title
Minimally Invasive Non Surgical Therapy Versus Conventional Scaling and Root Planing for Treatment of Periodontitis
Acronym
MINST
Official Title
Split Mouth Comparison of Minimally Invasive Non Surgical Therapy Versus Conventional Scaling and Root Planing for Treatment of Periodontitis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
April 2, 2019 (Actual)
Primary Completion Date
April 2, 2021 (Actual)
Study Completion Date
April 2, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Ljubljana

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Diseases
Keywords
Periodontitis, MINST, Scaling and root planing, Split mouth, 3D analysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Split mouth - experimental and control side in the same individual Side selection will be randomized
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Evaluator different to care provider
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MINST
Arm Type
Experimental
Arm Description
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.
Arm Title
Conventional SRP
Arm Type
Active Comparator
Arm Description
Conventional non-surgical mechanical treatment using piezoelectric device (PiezoLED, Kavo) and standard Gracey curettes under local anaesthesia.
Intervention Type
Procedure
Intervention Name(s)
MINST
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Conventional SRP
Intervention Description
Scaling and root planing with conventional instruments.
Primary Outcome Measure Information:
Title
Number of diseased sites
Description
Difference in No of Sites with PPD (probing pocket depth) > 4 mm and BOP (bleeding upon probing)
Time Frame
3 months, 6 months, 12 months
Secondary Outcome Measure Information:
Title
PPD
Description
Average probing pocket depth
Time Frame
3 months, 6 months, 12 months
Title
CAL
Description
Clinical attachment loss
Time Frame
3 months, 6 months, 12 months
Title
REC
Description
Gingival recession
Time Frame
3 months, 6 months, 12 months
Title
VOL
Description
Volumetric 3D differences evaluated by optical scanning
Time Frame
1 week, 1 month, 3 months, 6 months, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Faculty of Medicine
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Have no intention to share
Citations:
PubMed Identifier
30307641
Citation
Nibali L, Yeh YC, Pometti D, Tu YK. Long-term stability of intrabony defects treated with minimally invasive non-surgical therapy. J Clin Periodontol. 2018 Dec;45(12):1458-1464. doi: 10.1111/jcpe.13021. Epub 2018 Nov 5.
Results Reference
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PubMed Identifier
26257238
Citation
Nibali L, Pometti D, Chen TT, Tu YK. Minimally invasive non-surgical approach for the treatment of periodontal intrabony defects: a retrospective analysis. J Clin Periodontol. 2015 Sep;42(9):853-859. doi: 10.1111/jcpe.12443. Epub 2015 Sep 29.
Results Reference
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Minimally Invasive Non Surgical Therapy Versus Conventional Scaling and Root Planing for Treatment of Periodontitis

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