Barts and The London Dental Hospital
London, E1 2AD, United Kingdom
NCT Number: NCT03797807
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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Notify Me25 year–70 year
All sexes
Interventional
Not applicable
London, E1 2AD, United Kingdom
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 .
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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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
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
Geometrical/Thermal Imaging
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
Time frame: Up to 15 months
Probing Pocket Depth (PPD) change (in mm)
Time frame: Up to 15 months
Clinical Attachment Level (CAL) gain change (in mm)
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.
Time frame: Up to 15 months
Bacterial detection associated with presence of intrabony defects
Time frame: Up to 15 months
Gingival inflammation and healing (as measured by geometric/thermal stereophotogrammetry imaging in the 'GTI sub-study')
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.
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'.
Time frame: Up to 9 months
The responses will be scored on a six-point scale as:
Queen Mary University of London
Other
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
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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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