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This is a pilot prospective cohort study to assess the efficacy of minimally-invasive non-surgical periodontal therapy (MINST) for the treatment of teeth with unfavourable periodontal prognosis. 20 patients who have teeth with unfavourable periodontal prognosis (due to bone loss to the apex or furcation involvement grade II C) will receive minimally-invasive non-surgical treatment (MINST) and will be reassessed up to 12 months after treatment.
Twenty patients with advanced periodontitis who have teeth with unfavourable periodontal prognosis (due to bone loss to the apex or furcation involvement grade II C) will be entered in this study, conducted at Guy's Hospital in London, UK. The study has a prospective cohort design, so following baseline assessment, all patients will receive minimally-invasive non-surgical treatment (MINST). A total of 10 visits are planned over a 12-13 months period including initial treatment (MINST) and follow-up appointments.
The primary outcomes are radiographic defect depth (for teeth with bone loss to the apex, n=10) and furcation involvement (for teeth with furcation involvement degree II C, n=10). Paired t-test will be used to detect significant changes between baseline and 12 months for the primary outcomes using the patient as unit of analysis. Additional outcomes will be probing pocket depths (PPD), clinical attachment level (CAL), levels of inflammatory markers and growth factors in gingival crevicular fluid (GCF) and saliva and bacterial detection in periodontal pockets
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Minimally-invasive non-surgical therapy (MINST) | Other | Study treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Minimally-invasive non-surgical therapy (MINST) | Procedure | subgingival root debridement with a minimally-invasive approach using piezoelectric/ultrasonic instruments |
|
| Measure | Description | Time Frame |
|---|---|---|
| Radiographic defect depth | defect depth measured in radiographs in mm (as measured on standardised radiographs) | baseline-12 months |
| Furcation involvement | furcation involvement measured clinically (as measured based on validated horizontal and vertical furcation involvement scales, by Hamp et al. 1975 and Tarnow 1984). Hamp et al. 1975 goes from 1 to 3 in increasing severity. Tarnow et al. score goes from A to C in increasing severity | baseline-12 months |
| Measure | Description | Time Frame |
|---|---|---|
| probing pocket depth | measure of gingival pocket depth (in mm with the use of University of North Carolina(UNC)-15 probe) | 0-12 months |
| clinical attachment level | measure of pocket + gingival recession (in mm with use of UNC-15 probe) |
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Inclusion Criteria:
A. Furcation involvement degree II C based on Hamp et al. 1975 horizontal classification and Tarnow & Fletcher 1984 vertical classification (with concomitant furcation involvement (FI) not exceeding degree II on the other aspects of the same tooth) B. gingival recession ≤ 2mm on furcation site C. mobility maximum degree 2
A. radiographic bone loss to the apex or beyond the apex on at least one inter-dental aspect B. presence of severe attachment loss (>10 mm) at the same inter-proximal site/s and at least at one of either the buccal or lingual aspect (Cortellini et al. 2011) C. lack of function because of hypermobility, and/or lack of chewing strength, and/or pain, and/or recurrent periodontal infection/abscesses (Cortellini et al. 2011) D. positive response to vitality testing with electric pulp test (EPT) or previous endodontic treatment considered satisfactory, as judged by the examining clinician
- Willing to sign informed consent to take part in the study
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Luigi Nibali, PhD | Contact | 02071887188 | luigi.nibali@kcl.ac.uk |
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| ID | Term |
|---|---|
| D010518 | Periodontitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| 0-12 months |
| patient-reported outcomes | Oral Health Impact Profile (OHIP)-14 questionnaire (standardised scale based on 14 questions). Each question can score from 0 to 4 in increasing severity (maximum total score can be 14x4= 56) | 0-12 months |
| inflammatory response (in saliva and GCF) | measure of inflammatory cytokines (concentration in saliva and GCF), not restricted to some cytokines but explorative analyses of multiple cytokines by multiplex. The measure will be continuous, expressed for example in picograms/ml | 0-12 months |
| subgingival microbes | analysis of presence of microbes subgingivally (metagenomic analysis) | 0-12 months |