Periodontal Diseases Clinical Trial
— MINSTOfficial title:
Split Mouth Comparison of Minimally Invasive Non Surgical Therapy Versus Conventional Scaling and Root Planing for Treatment of Periodontitis
NCT number | NCT04036513 |
Other study ID # | 2019-1-1 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 2, 2019 |
Est. completion date | April 2, 2021 |
Verified date | April 2021 |
Source | University of Ljubljana |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Slovenia | Faculty of Medicine | Ljubljana |
Lead Sponsor | Collaborator |
---|---|
University of Ljubljana |
Slovenia,
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
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 |
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