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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04236648
Recruitment Status : Not yet recruiting
First Posted : January 22, 2020
Last Update Posted : January 22, 2020
Sponsor:
Information provided by (Responsible Party):
Guy's and St Thomas' NHS Foundation Trust

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.

Condition or disease Intervention/treatment Phase
Periodontitis Procedure: Minimally-invasive non-surgical therapy (MINST) Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical and Radiographic Changes Following Minimally-invasive Non-surgical Therapy in Teeth With Unfavourable Prognosis: A Pilot Prospective Cohort Study
Estimated Study Start Date : February 1, 2020
Estimated Primary Completion Date : October 31, 2021
Estimated Study Completion Date : October 31, 2023

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Radiographic defect depth [ Time Frame: baseline-12 months ]
    defect depth measured in radiographs in mm (as measured on standardised radiographs)

  2. Furcation involvement [ Time Frame: baseline-12 months ]
    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 :
  1. probing pocket depth [ Time Frame: 0-12 months ]
    measure of gingival pocket depth (in mm with the use of University of North Carolina(UNC)-15 probe)

  2. clinical attachment level [ Time Frame: 0-12 months ]
    measure of pocket + gingival recession (in mm with use of UNC-15 probe)

  3. patient-reported outcomes [ Time Frame: 0-12 months ]
    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)

  4. inflammatory response (in saliva and GCF) [ Time Frame: 0-12 months ]
    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

  5. subgingival microbes [ Time Frame: 0-12 months ]
    analysis of presence of microbes subgingivally (metagenomic analysis)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04236648


Contacts
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Contact: Luigi Nibali, PhD 02071887188 luigi.nibali@kcl.ac.uk

Sponsors and Collaborators
Guy's and St Thomas' NHS Foundation Trust

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Responsible Party: Guy's and St Thomas' NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT04236648    
Other Study ID Numbers: Perio-19-001
First Posted: January 22, 2020    Key Record Dates
Last Update Posted: January 22, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases