Minimally-invasive Non-surgical and Surgical Periodontitis Treatment

NCT03797807 | Active Not Recruiting

• 1 other identifier: 18/LO/1956
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

To compare the efficacy of a modified minimally-invasive non-surgical periodontal therapy (MINST) approach with a surgical approach (M-MIST) in determining bone and clinical attachment changes in intrabony defects

Conditions

Periodontitis

Outcome Measures

Primary Outcomes (1)

• Radiographic whole defect depth change

  Radiographic whole defect depth change in millimeters at 9 months \[considered a surrogate measure evaluating the entire regenerative process including bone, cementum and periodontal ligament

  9 months

Other Outcomes (8)

• Probing Pocket Depth (PPD) change

  Up to 15 months

• Clinical Attachment Level (CAL) gain change

  Up to 15 months

• Markers and growth factors in gingival crevicular fluid (GCF)

  Up to 15 months

Study Arms (4)

MINST

EXPERIMENTAL

Minimally invasive non surgical treatment

Procedure: MINST

MIST

ACTIVE COMPARATOR

Minimally invasive surgical treatment

Procedure: MIST

GTI + MINST

ACTIVE COMPARATOR

Minimally invasive non surgical treatment + Geometric/Thermal Imaging (GTI subgroup)

Procedure: MINST; Diagnostic Test: GTI subgroup (Geometrical/Thermal Imaging)

GTI + MIST

ACTIVE COMPARATOR

Minimally invasive surgical treatment + Geometric/Thermal Imaging (GTI subgroup)

Procedure: MIST; Diagnostic Test: GTI subgroup (Geometrical/Thermal Imaging)

Interventions

MINST PROCEDURE

A non-surgical minimally invasive treatment protocol, named MINST, has been proposed for the treatment of periodontal intrabony defects, in order to minimize patient discomfort and maximize the healing potential

GTI + MINST; MINST

MIST PROCEDURE

A minimally invasive surgical treatment protocol, named MIST, has been proposed for the treatment of periodontal intrabony defects, in order to minimize patient discomfort and maximize the healing potential

GTI + MIST; MIST

GTI subgroup (Geometrical/Thermal Imaging) DIAGNOSTIC_TEST

Geometrical/Thermal Imaging

GTI + MINST; GTI + MIST

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 25-70
• Diagnosis of 'Periodontitis' stage III or IV (grades A to C)
• Presence of ≥1 'intrabony defect' (PPD, \>5 mm with intrabony defect depth ≥3mm at screening radiograph),
• Signed informed consent. -

You may not qualify if:

• \. Smoking (current or in past 5 years) including e-cigarettes/vaping 2. Medical history including diabetes or hepatic or renal disease, or other serious medical conditions or transmittable diseases 3. History of conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures 4. Antiinflammatory or anticoagulant therapy during the month preceding the baseline exam 5. Systemic antibiotic therapy during the 3 months preceding the baseline exam 6. History of alcohol or drug abuse, 7. Self-reported pregnancy or lactation 8. 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, 9. 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

Study Sites (1)

Barts and The London Dental Hospital

London, E1 2AD, 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

• 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.

  PMID: 31351492 DERIVED

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Luigi Nibali, PhD

  Barts & The London School of Medicine & Dentistry, QMUL

  PRINCIPAL INVESTIGATOR

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: SPONSOR

Study Record Dates

• First Submitted: December 19, 2018
• First Posted: January 9, 2019
• Study Start: March 20, 2019
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: June 8, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)