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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Periodontitis
• Intervention / Treatment: Procedure: Minimally-invasive non-surgical therapy (MINST)

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

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Luigi Nibali, PhD; Phone Number: 02071887188; Email: luigi.nibali@kcl.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Minimally-invasive non-surgical therapy (MINST); Study treatment	Procedure: Minimally-invasive non-surgical therapy (MINST); subgingival root debridement with a minimally-invasive approach using piezoelectric/ultrasonic instruments

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: Guy's and St Thomas' NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2020
• Primary Completion (Anticipated): October 31, 2021
• Study Completion (Anticipated): October 31, 2023

Study Registration Dates

• First Submitted: January 13, 2020
• First Submitted That Met QC Criteria: January 20, 2020
• First Posted (Actual): January 22, 2020

Study Record Updates

• Last Update Posted (Actual): January 22, 2020
• Last Update Submitted That Met QC Criteria: January 20, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis
• Other Study ID Numbers: Perio-19-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No