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Completed

NCT Number: NCT03797807

Minimally-invasive Non-surgical and Surgical Periodontitis Treatment

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

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Key information

Age range

25 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Barts and The London Dental Hospital

London, E1 2AD, United Kingdom

About this study

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 .

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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. -

Exclusion criteria

  • 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).

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Treatment and study plan

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

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 subgroup (Geometrical/Thermal Imaging)

Diagnostic Test

Geometrical/Thermal Imaging

Primary outcomes

  1. Radiographic whole defect depth change

    Time frame: 9 months

    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

Other outcomes

  1. Probing Pocket Depth (PPD) change

    Time frame: Up to 15 months

    Probing Pocket Depth (PPD) change (in mm)

  2. Clinical Attachment Level (CAL) gain change

    Time frame: Up to 15 months

    Clinical Attachment Level (CAL) gain change (in mm)

  3. Markers and growth factors in gingival crevicular fluid (GCF)

    Time frame: Up to 15 months

    Levels of inflammatory markers and growth factors in gingival crevicular fluid (GCF). Specifically, markers related with the healing of epithelium, connective tissue, bone and related to inflammatory/host responses will be examined.

  4. Bacterial detection

    Time frame: Up to 15 months

    Bacterial detection associated with presence of intrabony defects

  5. Gingival inflammation and healing

    Time frame: Up to 15 months

    Gingival inflammation and healing (as measured by geometric/thermal stereophotogrammetry imaging in the 'GTI sub-study')

  6. Self administered OIDP (oral impact on daily performances index)

    Time frame: Up to 9 months

    We will utilize the oral impact on daily performances index (OIDP) to evaluate health and treatment outcomes. The OIDP focuses on the impact that the conditions of the teeth and mouth have on the physical/functional, psychological and social well-being of the person. Particularly, it assesses the impact of oral conditions on basic daily life activities and behaviours (eating, speaking, cleaning teeth, and going out, relaxing, smiling, major work or role, emotional stability, social contact). For each performance, both the frequency and severity of oral impacts are assessed. The overall OIDP score ranges from 0 to 100, with higher scores indicating worse quality of life.

  7. Global ratings on health and quality of life with Visual Analogue Scale (VAS)

    Time frame: Up to 9 months

    The VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'.

  8. Global ratings on health and quality of life with a question "How would you rate the quality of your life"

    Time frame: Up to 9 months

    The responses will be scored on a six-point scale as:

    • Excellent
    • Very good
    • Good
    • Fair
    • Poor
    • Very poor

Sponsors and collaborators

Lead sponsor

Queen Mary University of London

Other

Registry information

Official study title

Clinical and Radiographic Changes in Intrabony Defects Following Non-surgical vs. Surgical Minimally-invasive Periodontal Therapy. A Parallel Group, Single Centre, Examiner-blind, Non-inferiority Randomised Controlled Trial

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Jan 9, 2019
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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