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Minimally-invasive Non-surgical Treatment in Teeth With Unfavourable Prognosis

Primary Purpose

Periodontitis

Status

Not yet recruiting

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Minimally-invasive non-surgical therapy (MINST)

About this trial

This is an interventional treatment trial for Periodontitis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age 18-70
Diagnosis of Periodontitis stage III or IV (grade A, B or C) (Tonetti et al. 2018)
Presence of:
N=10: Maxillary or mandibular molars with:

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

N=10: 'Teeth with bone loss to the apex' (also defined as 'hopeless' by Cortellini et al. 2011), defined as having:

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:

Smoking (any current or in past 5 years)
Medical history including diabetes or hepatic or renal disease, or other serious medical conditions or transmittable disease
History of conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures
Anti-inflammatory or anticoagulant therapy during the month preceding the baseline exam
Systemic antibiotic therapy during the 3 months preceding the baseline exam
History of alcohol or drug abuse, vii) Self-reported pregnancy or lactation
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
Periodontal treatment to the study site within the last 12 months

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Minimally-invasive non-surgical therapy (MINST)

Arm Description

Study treatment

Outcomes

Primary Outcome Measures

Radiographic defect depth

defect depth measured in radiographs in mm (as measured on standardised radiographs)

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

Secondary Outcome Measures

probing pocket depth

measure of gingival pocket depth (in mm with the use of University of North Carolina(UNC)-15 probe)

clinical attachment level

measure of pocket + gingival recession (in mm with use of UNC-15 probe)

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)

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

subgingival microbes

analysis of presence of microbes subgingivally (metagenomic analysis)

Full Information

NCT ID

NCT04236648

First Posted

January 13, 2020

Last Updated

January 20, 2020

Sponsor

Guy's and St Thomas' NHS Foundation Trust

1. Study Identification

Unique Protocol Identification Number

NCT04236648

Brief Title

Minimally-invasive Non-surgical Treatment in Teeth With Unfavourable Prognosis

Official Title

Clinical and Radiographic Changes Following Minimally-invasive Non-surgical Therapy in Teeth With Unfavourable Prognosis: A Pilot Prospective Cohort Study

Study Type

Interventional

2. Study Status

Record Verification Date

January 2020

Overall Recruitment Status

Not yet recruiting

Study Start Date

February 1, 2020 (Anticipated)

Primary Completion Date

October 31, 2021 (Anticipated)

Study Completion Date

October 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Guy's and St Thomas' NHS Foundation Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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.

Detailed Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Periodontitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Minimally-invasive non-surgical therapy (MINST)

Arm Type

Other

Arm Description

Study treatment

Intervention Type

Procedure

Intervention Name(s)

Minimally-invasive non-surgical therapy (MINST)

Intervention Description

subgingival root debridement with a minimally-invasive approach using piezoelectric/ultrasonic instruments

Primary Outcome Measure Information:

Title

Radiographic defect depth

Description

defect depth measured in radiographs in mm (as measured on standardised radiographs)

Time Frame

baseline-12 months

Title

Furcation involvement

Description

Time Frame

baseline-12 months

Secondary Outcome Measure Information:

Title

probing pocket depth

Description

measure of gingival pocket depth (in mm with the use of University of North Carolina(UNC)-15 probe)

Time Frame

0-12 months

Title

clinical attachment level

Description

measure of pocket + gingival recession (in mm with use of UNC-15 probe)

Time Frame

0-12 months

Title

patient-reported outcomes

Description

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)

Time Frame

0-12 months

Title

inflammatory response (in saliva and GCF)

Description

Time Frame

0-12 months

Title

subgingival microbes

Description

analysis of presence of microbes subgingivally (metagenomic analysis)

Time Frame

0-12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age 18-70 Diagnosis of Periodontitis stage III or IV (grade A, B or C) (Tonetti et al. 2018) Presence of: N=10: Maxillary or mandibular molars with: 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 N=10: 'Teeth with bone loss to the apex' (also defined as 'hopeless' by Cortellini et al. 2011), defined as having: 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: Smoking (any current or in past 5 years) Medical history including diabetes or hepatic or renal disease, or other serious medical conditions or transmittable disease History of conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures Anti-inflammatory or anticoagulant therapy during the month preceding the baseline exam Systemic antibiotic therapy during the 3 months preceding the baseline exam History of alcohol or drug abuse, vii) Self-reported pregnancy or lactation 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 Periodontal treatment to the study site within the last 12 months

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Luigi Nibali, PhD

Phone

02071887188

luigi.nibali@kcl.ac.uk

12. IPD Sharing Statement

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Minimally-invasive Non-surgical Treatment in Teeth With Unfavourable Prognosis

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