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

Periodontal Diseases Clinical Trial

— MINST  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04036513
• Other study ID #: 2019-1-1
• Status: Completed
• Phase: N/A
• Start date: April 2, 2019
• Est. completion date: April 2, 2021

Study information

• Verified date: April 2021
• Source: University of Ljubljana
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 2, 2021
• Est. primary completion date: April 2, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Periodontal Diseases
• Periodontitis

Intervention

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.
• Conventional SRP
Scaling and root planing with conventional instruments.

Locations

Country	Name	City	State
Slovenia	Faculty of Medicine	Ljubljana

Sponsors (1)

Lead Sponsor	Collaborator
University of Ljubljana

Country where clinical trial is conducted

Slovenia, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	PPD	Average probing pocket depth	3 months, 6 months, 12 months
Secondary	CAL	Clinical attachment loss	3 months, 6 months, 12 months
Secondary	REC	Gingival recession	3 months, 6 months, 12 months
Secondary	VOL	Volumetric 3D differences evaluated by optical scanning	1 week, 1 month, 3 months, 6 months, 12 months