Clinical trial NCT04036513: Minimally Invasive Non Surgical Therapy Versus Conventional Scaling and Root Planing for Treatment of Periodontitis
Official title: Split Mouth Comparison of Minimally Invasive Non Surgical Therapy Versus Conventional Scaling and Root Planing for Treatment of Periodontitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontal Diseases
Keywords: Periodontitis
MINST
Scaling and root planing
Split mouth
3D analysis
Lead sponsor: University of Ljubljana
Sponsor class: OTHER
First posted: 2019-07-29
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Split mouth - experimental and control side in the same individual Side selection will be randomized
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Number of diseased sites
timeFrame: 3 months, 6 months, 12 months
Secondary outcomes:
measure: PPD
timeFrame: 3 months, 6 months, 12 months
measure: CAL
timeFrame: 3 months, 6 months, 12 months
measure: REC
timeFrame: 3 months, 6 months, 12 months
measure: VOL
timeFrame: 1 week, 1 month, 3 months, 6 months, 12 months
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: Faculty of Medicine
Study officials:
References:
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.
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.