Minimally-invasive Non-surgical and Surgical Periodontitis Treatment

NCT ID: NCT03797807

Last Updated: 2025-06-08

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-20
• Study Completion Date: 2025-12-31

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

Detailed Description

Periodontal diseases are inflammatory conditions that affect the supporting apparatus of the teeth, including gingiva and alveolar bone. The bone loss resulting from periodontitis often is irregular and localised, giving onset to 'intrabony' or 'vertical defects' affecting one side of the tooth more than the other and more than on the neighbouring teeth. Periodontal intrabony defects have been associated with a higher risk of further progression and eventually tooth loss.

The treatment of periodontitis involves a non-specific reduction of the bacterial load below the gingival margin. This is achieved by oral hygiene instructions (OHI) and non-surgical periodontal therapy (NSPT), aimed at removing calculus and disrupting the plaque biofilm from the affected root surfaces. Intrabony defects are considered sites requiring therapy, often beyond NSPT. Decades ago, intrabony defects were treated with surgical elimination of the defect achieved by sacrificing the adjacent healthy supportive or non-supportive bone. More recently periodontal regenerative procedures have been advocated for deep intrabony defects, which are considered amenable for guided tissue regeneration. This technique results in regeneration of periodontal attachment measurable histologically and radiographically and measurable clinically. However, this is associated with potential morbidity and high costs due to the use of bone graft and barrier materials and is not always predictable. The more recent introduction of minimally-invasive surgical therapy (MIST), modified-MIST (M-MIST) and single-flap approach suggested that the use of biomaterials may not be so crucial for obtaining periodontal regeneration.

Retrospective studies from the investigator's group have shown that minimally invasive non-surgical periodontal treatment of intrabony defects results in clinical improvements (measured as PPD reductions and clinical attachment level-CAL- gain) but also in bone fill of the bony defects, measurable radiographically. The extent of the radiographic resolution of the defect was positively associated with initial defect depth and use of adjunctive antibiotics, while smoking seemed to negatively influence this outcome. A non-surgical minimally-invasive treatment protocol, named MINST, has been proposed along these principles. A more recent retrospective analysis has revealed a reduction in bony defect of nearly 3 mm for cases treated with minimally-invasive non-surgical therapy. The effect of MINST may be mediated by improved blood flow and stable blood clot in the intrabony defect. However, very few studies have been published on MINST and no data are available on the comparison between MINST and MIST.

This is a parallel group, single centre, examiner-blind, non-inferiority randomized controlled trial to compare the effect of a modified minimally-invasive non-surgical therapy (MINST) approach to minimally invasive surgical treatment (MIST) in the healing of periodontal intrabony defects in 66 patients with periodontitis .

Conditions

Periodontitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

MINST

Minimally invasive non surgical treatment

Group Type: EXPERIMENTAL

MINST

Intervention Type: 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

MIST

Minimally invasive surgical treatment

Group Type: ACTIVE_COMPARATOR

MIST

Intervention Type: 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 + MINST

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

Group Type: ACTIVE_COMPARATOR

MINST

Intervention Type: 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 subgroup (Geometrical/Thermal Imaging)

Intervention Type: DIAGNOSTIC_TEST

Geometrical/Thermal Imaging

GTI + MIST

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

Group Type: ACTIVE_COMPARATOR

MIST

Intervention Type: 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 subgroup (Geometrical/Thermal Imaging)

Intervention Type: DIAGNOSTIC_TEST

Geometrical/Thermal Imaging

Interventions

MINST

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

Intervention Type: PROCEDURE

MIST

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

Intervention Type: PROCEDURE

GTI subgroup (Geometrical/Thermal Imaging)

Geometrical/Thermal Imaging

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

1. Age 25-70

2. Diagnosis of 'Periodontitis' stage III or IV (grades A to C)

3. Presence of ≥1 'intrabony defect' (PPD, >5 mm with intrabony defect depth ≥3mm at screening radiograph),

4. Signed informed consent. -

Exclusion Criteria

1. 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).

-

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Queen Mary University of London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Luigi Nibali, PhD

Role: PRINCIPAL_INVESTIGATOR

Barts & The London School of Medicine & Dentistry, QMUL

Locations

Barts and The London Dental Hospital

London, , United Kingdom

Countries

United Kingdom

References

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.

Reference Type: BACKGROUND

PMID: 11276518 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 2066446 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12787211 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 6964676 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11276509 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16625546 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19186978 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21303402 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21091528 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21284549 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26257238 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31351492 (View on PubMed)

Other Identifiers

18/LO/1956

Identifier Type: -

Identifier Source: org_study_id