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

NCT04036513 | Completed

• 1 other identifier: 2019-1-1
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontal Diseases

Keywords

Periodontitis; MINST; Scaling and root planing; Split mouth; 3D analysis

Outcome Measures

Primary Outcomes (1)

• Number of diseased sites

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

  3 months, 6 months, 12 months

Secondary Outcomes (4)

• PPD

  3 months, 6 months, 12 months

• CAL

  3 months, 6 months, 12 months

• REC

  3 months, 6 months, 12 months

• VOL

  1 week, 1 month, 3 months, 6 months, 12 months

Study Arms (2)

MINST

EXPERIMENTAL

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

Conventional SRP

ACTIVE COMPARATOR

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

Procedure: Conventional SRP

Interventions

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.

MINST

Conventional SRP PROCEDURE

Scaling and root planing with conventional instruments.

Conventional SRP

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Ljubljana: lead

Study Sites (1)

Faculty of Medicine

Ljubljana, 1000, Slovenia

Location

Related Publications (3)

• 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.

  PMID: 30307641 BACKGROUND

• 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.

  PMID: 26257238 BACKGROUND

• 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.

  PMID: 37014505 DERIVED

MeSH Terms

Conditions

Periodontal Diseases; Periodontitis

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Evaluator different to care provider
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist. Prof.

Model Details: Split mouth - experimental and control side in the same individual Side selection will be randomized

Study Record Dates

• First Submitted: July 25, 2019
• First Posted: July 29, 2019
• Study Start: April 2, 2019
• Primary Completion: April 2, 2021
• Study Completion: April 2, 2021
• Last Updated: April 29, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)