Clinical trial NCT03797807: Minimally-invasive Non-surgical and Surgical Periodontitis Treatment
Official 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Periodontitis
Lead sponsor: Queen Mary University of London
Sponsor class: OTHER
First posted: 2019-01-09
Enrollment: 66
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 .

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).

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Primary outcomes:
measure: Radiographic whole defect depth change
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
measure: Probing Pocket Depth (PPD) change
timeFrame: Up to 15 months
measure: Clinical Attachment Level (CAL) gain change
timeFrame: Up to 15 months
measure: Markers and growth factors in gingival crevicular fluid (GCF)
timeFrame: Up to 15 months
measure: Bacterial detection
timeFrame: Up to 15 months
measure: Gingival inflammation and healing
timeFrame: Up to 15 months
measure: Self administered OIDP (oral impact on daily performances index)
timeFrame: Up to 9 months
measure: Global ratings on health and quality of life with Visual Analogue Scale (VAS)
timeFrame: Up to 9 months
measure: Global ratings on health and quality of life with a question "How would you rate the quality of your life"
timeFrame: Up to 9 months
Locations:
city: London
country: United Kingdom
facility: Barts and The London Dental Hospital
Study officials:
affiliation: Barts & The London School of Medicine & Dentistry, QMUL
name: Luigi Nibali, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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