Minimally Invasive Non- Surgical Periodontal Therapy of Intrabony Defects: Healing Patterns and Smoking Impact

NCT07117097 | Not Yet Recruiting

• 1 other identifier: Φ076/13310/Σ6276/5Νοε24/251ΓΝΑ
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is consisted of two arms. At first, a randomized controlled clinical trial will be conducted. Eighty systematically healthy, non-smoker patients with Periodontitis stage III or IV, grades B to C will be included. Each patient will have to present one intrabony defect site ( site with Probing Depth (PD)\>5mm and radiographic defect depth \> or =3mm). The patients will be randomized in two groups, regarding the treatment intervention of the intrabony defects: Group A (conventional Non-Surgical Periodontal Treatment, cNSPT) and Group B (Minimally Invasive Non-Surgical Therapy, MINST). At 5 days and 3 months following intervention, GCF samples will be collected from the intrabony defects in order to assess the molecular healing patterns through intergroup comparisons of inflammation and healing biomarkers. Then two prospective cohort studies will be conducted. The Group B patients will be matched with forty systematically healthy, smoker patients (Group C) with Periodontitis stage III or IV, grades B to C with each one presenting one intrabony defect site ( site with Probing Depth (PD)\>5mm and radiographic defect depth \> or =3mm). Then MINST will be performed in the patients of Group C and the two groups will be compared regarding the clinical and radiographic data obtained by clinical and radiographic examinations performed in both groups' intrabony defects pre-treatment and 6 months following the intervention (first prospective study) and regarding the differences in regeneration biomarkers in GCF samples obtained from the intrabony defects 5 days and 3 months post-treatment (second prospective study).

Conditions

Periodontitis

Keywords

Periodontitis; Intrabony defect; GCF; Minimally invasive; smoking; non surgical; bone

Outcome Measures

Primary Outcomes (2)

• Concentrations of GCF inflammation and regeneration biomarkers.

  Concentrations will be measured in pg/ml

  At 5 days and 3 months following intervention

• Total amounts of GCF inflammation and regeneration biomarkers

  Total amounts will be measured in pg/30 s

  At 5 days and 3 months following intervention

Secondary Outcomes (10)

• Plaque index (PI)

  pre-treatment and 6 months following the intervention

• Gingival index (GI)

  pre-treatment and 6 months following the intervention

• Bleeding on probing (BoP)

  pre-treatment and 6 months following the intervention

• Probing depth (PD)

  pre-treatment and 6 months following the intervention

• Gingival recession (REC)

  pre-treatment and 6 months following the intervention

Study Arms (3)

Non-smokers cNSPT

ACTIVE COMPARATOR

Participants will be non-smokers. Periodontal treatment intervention will include: thorough debridement of the root surface under local anaesthesia, using conventional piezoelectric devices (EMS, Switzerland) and hand instruments (Gracey, Hu Friedy).

Procedure: conventional Non-Surgical Periodontal Treatment (cNSPT)

Non-smokers MINST

EXPERIMENTAL

Participants will be non-smokers. Periodontal treatment intervention will include: local anaesthesia by infiltration without adrenaline, thorough debridement of the root surface through a subpapillary access using exclusively piezoelectric devices with specific thin and delicate tips (EMS, Switzerland) and 4X magnification loupes, taking care to minimize the soft tissue trauma and to stimulate the formation of a stable blood clot.

Procedure: Minimally Invasive Non- Surgical Periodontal Therapy (MINST)

Smokers MINST

EXPERIMENTAL

Participants will be smokers. Periodontal treatment intervention will include: local anaesthesia by infiltration without adrenaline, thorough debridement of the root surface through a subpapillary access using exclusively piezoelectric devices with specific thin and delicate tips (EMS, Switzerland) and 4X magnification loupes, taking care to minimize the soft tissue trauma and to stimulate the formation of a stable blood clot.

Procedure: Minimally Invasive Non- Surgical Periodontal Therapy (MINST)

Interventions

Minimally Invasive Non- Surgical Periodontal Therapy (MINST) PROCEDURE

The procedure consists of thorough debridement of the root surface through a subpapillary access using exclusively piezoelectric devices with specific thin and delicate tips (EMS, Switzerland) and 4X magnification loupes, taking care to minimize the soft tissue trauma and to stimulate the formation of a stable blood clot

Non-smokers MINST; Smokers MINST

conventional Non-Surgical Periodontal Treatment (cNSPT) PROCEDURE

The intervention consists of thorough debridement of the root surface under local anaesthesia, using conventional piezoelectric devices and hand instruments

Also known as: scaling and root planing, SRP, non-surgical periodontal treatment, periodontal debridement

Non-smokers cNSPT

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with Periodontitis stage III or IV, grades B to C . Each patient will have to present one intrabony defect site ( site with Probing Depth (PD)\>5mm and radiographic defect depth \>3mm).
• participants should be free of any systemic or oral conditions that could affect disease progression or treatment outcomes

You may not qualify if:

• diabetes
• hepatic or renal disease
• history of conditions requiring prophylactic antibiotics
• anti-inflammatory or anticoagulant therapy the preceding month
• systemic antibiotic therapy the preceding 3 months
• history of alcohol or drug abuse
• self-reported pregnancy or lactation
• other severe acute or chronic medical or psychiatric condition
• periodontal treatment within the last 12 months
• presence of drug-induced gingival overgrowth

Sponsors & Collaborators

• University of Turku: lead
• 251 Hellenic Air Force & VA General Hospital: collaborator

Related Publications (21)

• Nibali L, Koidou V, Salomone S, Hamborg T, Allaker R, Ezra R, Zou L, Tsakos G, Gkranias N, Donos N. Minimally invasive non-surgical vs. surgical approach for periodontal intrabony defects: a randomised controlled trial. Trials. 2019 Jul 27;20(1):461. doi: 10.1186/s13063-019-3544-8.

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• Anoixiadou S, Parashis A, Vouros I. Enamel matrix derivative as an adjunct to minimally invasive non-surgical treatment of intrabony defects: A randomized clinical trial. J Clin Periodontol. 2022 Feb;49(2):134-143. doi: 10.1111/jcpe.13567. Epub 2021 Nov 9.

  PMID: 34708441 BACKGROUND

• Reynolds MA, Kao RT, Camargo PM, Caton JG, Clem DS, Fiorellini JP, Geisinger ML, Mills MP, Nares S, Nevins ML. Periodontal regeneration - intrabony defects: a consensus report from the AAP Regeneration Workshop. J Periodontol. 2015 Feb;86(2 Suppl):S105-7. doi: 10.1902/jop.2015.140378. Epub 2014 Oct 15.

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• Chang J, Meng HW, Lalla E, Lee CT. The impact of smoking on non-surgical periodontal therapy: A systematic review and meta-analysis. J Clin Periodontol. 2021 Jan;48(1):60-75. doi: 10.1111/jcpe.13384. Epub 2020 Nov 5.

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• Haber J, Wattles J, Crowley M, Mandell R, Joshipura K, Kent RL. Evidence for cigarette smoking as a major risk factor for periodontitis. J Periodontol. 1993 Jan;64(1):16-23. doi: 10.1902/jop.1993.64.1.16.

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• Liu S, Hu B, Zhang Y, Li W, Song J. Minimally Invasive Surgery Combined with Regenerative Biomaterials in Treating Intra-Bony Defects: A Meta-Analysis. PLoS One. 2016 Jan 19;11(1):e0147001. doi: 10.1371/journal.pone.0147001. eCollection 2016.

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• 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.

  PMID: 26257238 BACKGROUND

• Cortellini P, Tonetti MS. Clinical and radiographic outcomes of the modified minimally invasive surgical technique with and without regenerative materials: a randomized-controlled trial in intra-bony defects. J Clin Periodontol. 2011 Apr;38(4):365-73. doi: 10.1111/j.1600-051X.2011.01705.x. Epub 2011 Feb 8.

  PMID: 21303402 BACKGROUND

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  PMID: 22050544 BACKGROUND

• Cortellini P, Tonetti MS. Improved wound stability with a modified minimally invasive surgical technique in the regenerative treatment of isolated interdental intrabony defects. J Clin Periodontol. 2009 Feb;36(2):157-63. doi: 10.1111/j.1600-051X.2008.01352.x.

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• Cortellini P, Tonetti MS. A minimally invasive surgical technique with an enamel matrix derivative in the regenerative treatment of intra-bony defects: a novel approach to limit morbidity. J Clin Periodontol. 2007 Jan;34(1):87-93. doi: 10.1111/j.1600-051X.2006.01020.x.

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MeSH Terms

Conditions

Periodontitis; Smoking

Interventions

Tooth Exfoliation; Root Planing; Periodontal Debridement

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Behavior

Intervention Hierarchy (Ancestors)

Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Dental Scaling; Dental Prophylaxis; Periodontics; Dentistry; Subgingival Curettage; Preventive Dentistry

Study Officials

• ILIAS OIKONOMOU, DDS,MSc

  Institute of Dentistry, University of Turku, Turku, Finland

  PRINCIPAL INVESTIGATOR

• Ulvi Gürsoy, DDS, PhD

  Institute of Dentistry, University of Turku, Turku, Finland

  STUDY DIRECTOR

Central Study Contacts

ILIAS OIKONOMOU, DDS, MSc

CONTACT

+306906522601; oikonomou.perioortho@gmail.com

Ulvi Gürsoy, DDS, PhD

CONTACT

+358 50 514 8132; ulvi.gursoy@utu.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Periodontist, Department of Periodontology, 251 Hellenic Air Force & VA Hospital, Athens, Greece, Doctoral researcher, Department of Periodontology, Institute of Dentistry, University of Turku, Turku, Finland

Model Details: At first a Randomized Controlled clinical trial study (RCT) will be conducted and then a prospective cohort study

Study Record Dates

• First Submitted: March 31, 2025
• First Posted: August 12, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Access Criteria: The IPD sharing requests will be reviewed by the principal investigator and the study director.