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Periodontal DiseasesMINSTNCT04036513

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

A study testing MINST and Conventional SRP in people with Periodontal Diseases, run by University of Ljubljana at 1 site in Slovenia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Periodontal Diseases
What is being tested?
MINST and Conventional SRP
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteSlovenia
Study dates
2 Apr 2019to 2 Apr 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Slovenia1 site

  • Faculty of Medicine

    Ljubljana, Slovenia, 1000

Other trials in Slovenia

About this study

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

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.

Being tested
MINST, Conventional SRP
Keywords
Periodontitis, MINST, Scaling and root planing, Split mouth, 3D analysis
Medical subject headings
Periodontal Diseases, Periodontitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MINSTProcedure or surgery

    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 SRPProcedure or surgery

    Scaling and root planing with conventional instruments.

Study groups in NCT04036513
Study groupRoleWhat they receive
MINSTExperimentalUsage 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.
Receives: Procedure: MINST
Conventional SRPActive comparatorConventional non-surgical mechanical treatment using piezoelectric device (PiezoLED, Kavo) and standard Gracey curettes under local anaesthesia.
Receives: Procedure: Conventional SRP

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of diseased sites

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

    Measured: 3 months, 6 months, 12 months

Secondary outcomes (4)

  1. PPD

    Average probing pocket depth

    Measured: 3 months, 6 months, 12 months

  2. CAL

    Clinical attachment loss

    Measured: 3 months, 6 months, 12 months

  3. REC

    Gingival recession

    Measured: 3 months, 6 months, 12 months

  4. VOL

    Volumetric 3D differences evaluated by optical scanning

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2019
  2. Study start2 Apr 2019
  3. Primary completion2 Apr 2021
  4. Study completion2 Apr 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Split mouth - experimental and control side in the same individual Side selection will be randomized
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04036513
Sponsor's protocol ID
2019-1-1
Acronym
MINST
Status last verified
Oct 2026
First submitted
25 Jul 2019
Last updated
2 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Have no intention to share

Publications

  • 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.

    PubMed 30307641

  • 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.

    PubMed 26257238

  • 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.

    PubMed 37014505

Questions about this trial

What is this clinical trial studying?

A study testing MINST and Conventional SRP in people with Periodontal Diseases, run by University of Ljubljana at 1 site in Slovenia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of diseased sites (time frame: 3 months, 6 months, 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04036513, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.

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