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

Study Overview
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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.

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

Conditions
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Periodontal Diseases

Intervention / Treatment
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* Procedure: MINST
* Procedure: Conventional SRP


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Split mouth - experimental and control side in the same individual Side selection will be randomized
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MINST<br>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<br>* 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.<br>|
| Active Comparator: Conventional SRP<br>Conventional non-surgical mechanical treatment using piezoelectric device (PiezoLED, Kavo) and standard Gracey curettes under local anaesthesia. | Procedure: Conventional SRP<br>* Scaling and root planing with conventional instruments.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PPD | Average probing pocket depth | 3 months, 6 months, 12 months | 
| CAL | Clinical attachment loss | 3 months, 6 months, 12 months | 
| REC | Gingival recession | 3 months, 6 months, 12 months | 
| VOL | Volumetric 3D differences evaluated by optical scanning | 1 week, 1 month, 3 months, 6 months, 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Periodontitis, MINST, Scaling and root planing, Split mouth, 3D analysis