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

NCT ID: NCT04036513

Last Updated: 2021-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-02

Study Completion Date

2021-04-02

Brief Summary

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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

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Conditions

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Periodontal Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Split mouth - experimental and control side in the same individual Side selection will be randomized
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
Evaluator different to care provider

Study Groups

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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.

Group Type EXPERIMENTAL

MINST

Intervention Type 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

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

Group Type ACTIVE_COMPARATOR

Conventional SRP

Intervention Type PROCEDURE

Scaling and root planing with conventional instruments.

Interventions

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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.

Intervention Type PROCEDURE

Conventional SRP

Scaling and root planing with conventional instruments.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Ljubljana

OTHER

Sponsor Role lead

Responsible Party

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Rok Gašperšič

Assist. Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Medicine

Ljubljana, , Slovenia

Site Status

Countries

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Slovenia

References

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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.

Reference Type BACKGROUND
PMID: 30307641 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26257238 (View on PubMed)

Kucic AC, Gaspersic R. Minimally invasive non-surgical therapy (MINST) in stage III periodontitis patients: 6-month results of a split-mouth, randomised controlled clinical trial. Clin Oral Investig. 2023 May;27(5):2075-2087. doi: 10.1007/s00784-023-04994-4. Epub 2023 Apr 4.

Reference Type DERIVED
PMID: 37014505 (View on PubMed)

Other Identifiers

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2019-1-1

Identifier Type: -

Identifier Source: org_study_id

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