Minimally-invasive Non-surgical Therapy of Intrabony Defects

NCT03741374 | Active Not Recruiting

• 1 other identifier: QMERC 2018/56
• Study Type: interventional
• Target: 66
• Locations: 4 countries
• Sites: 9

Brief Summary

This investigation aims to assess the clinical and radiographic outcomes of intrabony defects treated with minimally-invasive non-surgical therapy.

Conditions

Chronic Periodontitis

Outcome Measures

Primary Outcomes (1)

• Radiographic whole defect depth reduction

  Radiographic whole defect depth reduction in millimeters at 12 months \[considered a surrogate measure evaluating the entire regenerative process including bone, cementum and periodontal ligament (Polimeni et al. 2009)\]

  12 months

Secondary Outcomes (2)

• Probing Pocket Depth change

  12 months

• Clinical Attachment Level change

  12 months

Study Arms (1)

Minimally-invasive non-surgical therapy

EXPERIMENTAL

Intrabony defects treated with Minimally-invasive non-surgical therapy (MINST)

Procedure: Minimally-invasive non-surgical therapy (MINST)

Interventions

Minimally-invasive non-surgical therapy (MINST) PROCEDURE

A non-surgical minimally-invasive treatment protocol, named MINST, has been proposed (Ribeiro et al. 2011) for the treatment of periodontitis, in order to minimise patient discomfort and maximise the healing potential. This technique usually involve the use of magnification lenses or microscopes and small instruments which would reduce the risk of tissue trauma compared with traditional instruments.

Minimally-invasive non-surgical therapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-70
• Diagnosis of Periodontitis (Tonetti et al. 2018)
• Presence of ≥1 'intrabony defect' (PPD and CAL \>5 mm with radiographic intrabony defect depth ≥3mm and not in a site associated with furcation involvement)
• Signed informed consent \[Participants must be able and willing to read and sign a copy of the "Informed Consent Form" (ICF) form after reading the "Patient Information Leaflet" (PIS), and after the nature of the study has been fully explained\].

You may not qualify if:

• Smoking (current or in past 5 years, including electronic cigarettes, vaping or similar)
• Medical history including diabetes or hepatic or renal disease, or other serious medical conditions or transmittable diseases
• Presence of drug-induced gingival enlargement
• History of conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures
• Anti-inflammatory or anticoagulant therapy during the month preceding the baseline exam
• Systemic antibiotic therapy during the 3 months preceding the baseline exam,
• Taking immunosuppressant medications
• Known allergy to local anaesthetic
• History of alcohol or drug abuse
• Self-reported pregnancy or lactation
• Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that according to the investigator may increase the risk associated with trial participation
• Periodontal treatment to the study site within the last 12 months (excluding not-extensive subgingival debridement as judged by the examining clinician).

Sponsors & Collaborators

• Queen Mary University of London: lead
• Ravenscourt Dental Practice: collaborator
• South Coast Dental Specialists: collaborator
• Claremonth Dental Practice: collaborator
• Pall Mall Dental: collaborator
• Rose Lane Dental Practice: collaborator
• Periosouth: collaborator
• Clinica de Periodoncia: collaborator
• Studio Dentistico Associato Montevecchi D' Alessandro: collaborator
• 11th floor 141 Queen St. Brisdane: collaborator
• The Dentist: collaborator
• High Barnet Dental Care: collaborator

Study Sites (9)

Dr Ryan Lee Private Practice

Brisbane, QLD 4000, Australia

Location

Studio Dentistico Associato Montevecchi D'Alessandro

Forlimpopoli, 47034, Italy

Location

Clinica de Periodoncia

A Coruña, 15003, Spain

Location

South Coast Dental Specialists

Dorchester, DT1 1DT, United Kingdom

Location

The Dentist

London, CM23 3AZ, United Kingdom

Location

High Barnet Dental Care

London, EN5 5UR, United Kingdom

Location

Pall Mall Dental

London, SW1Y 5LU, United Kingdom

Location

Ravenscourt Dental Practice

London, W6 0SL, United Kingdom

Location

Claremont Dental Practice

Middlesex, TW1 3EJ, United Kingdom

Location

Related Publications (12)

• Papapanou PN, Tonetti MS. Diagnosis and epidemiology of periodontal osseous lesions. Periodontol 2000. 2000 Feb;22:8-21. doi: 10.1034/j.1600-0757.2000.2220102.x. No abstract available.

  PMID: 11276518 BACKGROUND

• Papapanou PN, Wennstrom JL. The angular bony defect as indicator of further alveolar bone loss. J Clin Periodontol. 1991 May;18(5):317-22. doi: 10.1111/j.1600-051x.1991.tb00435.x.

  PMID: 2066446 BACKGROUND

• Heitz-Mayfield LJ, Trombelli L, Heitz F, Needleman I, Moles D. A systematic review of the effect of surgical debridement vs non-surgical debridement for the treatment of chronic periodontitis. J Clin Periodontol. 2002;29 Suppl 3:92-102; discussion 160-2. doi: 10.1034/j.1600-051x.29.s3.5.x.

  PMID: 12787211 BACKGROUND

• Nyman S, Lindhe J, Karring T, Rylander H. New attachment following surgical treatment of human periodontal disease. J Clin Periodontol. 1982 Jul;9(4):290-6. doi: 10.1111/j.1600-051x.1982.tb02095.x.

  PMID: 6964676 BACKGROUND

• Cortellini P, Tonetti MS. Focus on intrabony defects: guided tissue regeneration. Periodontol 2000. 2000 Feb;22:104-32. doi: 10.1034/j.1600-0757.2000.2220108.x. No abstract available.

  PMID: 11276509 BACKGROUND

• Needleman IG, Worthington HV, Giedrys-Leeper E, Tucker RJ. Guided tissue regeneration for periodontal infra-bony defects. Cochrane Database Syst Rev. 2006 Apr 19;(2):CD001724. doi: 10.1002/14651858.CD001724.pub2.

  PMID: 16625546 BACKGROUND

• Trombelli L, Farina R, Franceschetti G, Calura G. Single-flap approach with buccal access in periodontal reconstructive procedures. J Periodontol. 2009 Feb;80(2):353-60. doi: 10.1902/jop.2009.080420.

  PMID: 19186978 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

• Nibali L, Pometti D, Tu YK, Donos N. Clinical and radiographic outcomes following non-surgical therapy of periodontal infrabony defects: a retrospective study. J Clin Periodontol. 2011 Jan;38(1):50-7. doi: 10.1111/j.1600-051X.2010.01648.x. Epub 2010 Nov 22.

  PMID: 21091528 BACKGROUND

• Ribeiro FV, Casarin RC, Palma MA, Junior FH, Sallum EA, Casati MZ. Clinical and patient-centered outcomes after minimally invasive non-surgical or surgical approaches for the treatment of intrabony defects: a randomized clinical trial. J Periodontol. 2011 Sep;82(9):1256-66. doi: 10.1902/jop.2011.100680. Epub 2011 Feb 2.

  PMID: 21284549 BACKGROUND

• 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

• Mehta J, Montevecchi M, Garcia-Sanchez R, Onabolu O, Linares A, Eriksson F, Ghezzi C, Donghi C, Lu EM, Nibali L. Minimally invasive non-surgical periodontal therapy of intrabony defects: A prospective multi-centre cohort study. J Clin Periodontol. 2024 Jul;51(7):905-914. doi: 10.1111/jcpe.13984. Epub 2024 May 6.

  PMID: 38710583 DERIVED

MeSH Terms

Conditions

Chronic Periodontitis

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Luigi Nibali, DipDent, MSc, PhD

  Barts & The London School of Medicine & Dentistry, QMUL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2018
• First Posted: November 14, 2018
• Study Start: February 1, 2019
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: June 8, 2025

Record last verified: 2025-06

Locations

ES (1); GB (6); AU (1); IT (1)