Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Minimally-invasive Non-surgical Therapy of Intrabony Defects

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: NCT03741374
Recruitment Status : Recruiting
First Posted : November 14, 2018
Last Update Posted : April 8, 2019
Sponsor:
Collaborators:
Ravenscourt Dental Practice
South Coast Dental Specialists
Claremonth Dental Practice
Pall Mall Dental
Rose Lane Dental Practice
Periosouth
Clinica de Periodoncia
Studio Dentistico Associato Montevecchi D' Alessandro
11th floor 141 Queen St. Brisdane
The Dentist
High Barnet Dental Care
Information provided by (Responsible Party):
Queen Mary University of London

Brief Summary:
This investigation aims to assess the clinical and radiographic outcomes of intrabony defects treated with minimally-invasive non-surgical therapy.

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

Detailed Description:

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.

A retrospective study from our group has shown that 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 generalizability and wide applicability of MINST.

This is a prospective cohort multicentre study to assess the effect of a modified minimally-invasive non-surgical therapy (MINST) approach in the healing of 100 periodontal intrabony defects in patients with periodontitis seen in private practice. The therapists responsible for delivering this treatment as part of this study all have experience in routinely carrying out this or similar procedures for this type of periodontal defects.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Analysis of Intrabony Defects Treated With Minimally-invasive Non-surgical Therapy: A Prospective Cohort Multicentre Study
Actual Study Start Date : February 1, 2019
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : February 2022

Arm Intervention/treatment
Experimental: Minimally-invasive non-surgical therapy
Intrabony defects treated with Minimally-invasive non-surgical therapy (MINST)
Procedure: Minimally-invasive non-surgical therapy (MINST)
A non-surgical minimally-invasive treatment protocol, named MINST, has been proposed (Ribeiro et al. 2011) for the treatment of periodontitis, in order to minimise patient discomfort and maximise the healing potential. This technique usually involve the use of magnification lenses or microscopes and small instruments which would reduce the risk of tissue trauma compared with traditional instruments.




Primary Outcome Measures :
  1. Radiographic whole defect depth reduction [ Time Frame: 12 months ]
    Radiographic whole defect depth reduction in millimeters at 12 months [considered a surrogate measure evaluating the entire regenerative process including bone, cementum and periodontal ligament (Polimeni et al. 2009)]


Secondary Outcome Measures :
  1. Probing Pocket Depth change [ Time Frame: 12 months ]
    Probing Pocket Depth (PPD) change (in mm) at 12 months

  2. Clinical Attachment Level change [ Time Frame: 12 months ]
    Clinical Attachment Level (CAL) change at 12 months



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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age 18-70
  2. Diagnosis of Periodontitis (Tonetti et al. 2018)
  3. Presence of ≥1 'intrabony defect' (PPD and CAL >5 mm with radiographic intrabony defect depth ≥3mm and not in a site associated with furcation involvement)
  4. Signed informed consent [Participants must be able and willing to read and sign a copy of the "Informed Consent Form" (ICF) form after reading the "Patient Information Leaflet" (PIS), and after the nature of the study has been fully explained].

Exclusion Criteria:

  1. Smoking (current or in past 5 years, including electronic cigarettes, vaping or similar)
  2. Medical history including diabetes or hepatic or renal disease, or other serious medical conditions or transmittable diseases
  3. Presence of drug-induced gingival enlargement
  4. History of conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures
  5. Anti-inflammatory or anticoagulant therapy during the month preceding the baseline exam
  6. Systemic antibiotic therapy during the 3 months preceding the baseline exam,
  7. Taking immunosuppressant medications
  8. Known allergy to local anaesthetic
  9. History of alcohol or drug abuse
  10. Self-reported pregnancy or lactation
  11. 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
  12. Periodontal treatment to the study site within the last 12 months (excluding not-extensive subgingival debridement as judged by the examining clinician).

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): NCT03741374


Contacts
Layout table for location contacts
Contact: Luigi Nibali, DipDent, MSc, PhD +44(0)2078823134 l.nibali@qmul.ac.uk

Locations
Layout table for location information
Australia
Dr Ryan Lee Private Practice Recruiting
Brisbane, Australia, QLD 4000
Contact: Ryan Lee       r.sblee@uq.edu.au   
Principal Investigator: Ryan Lee         
Italy
Studio Dentistico Associato Montevecchi D'Alessandro Not yet recruiting
Forlimpopoli, Italy, 47034
Contact: Marco Montevecchi       m.montevecchi@unibo.it   
Principal Investigator: Marco Montevecchi         
Spain
Clinica de Periodoncia Not yet recruiting
Coruna, Spain, 15003
Contact: Antonio Linares       antonio@antoniolinares.com   
Principal Investigator: Antonio Linares         
United Kingdom
South Coast Dental Specialists Not yet recruiting
Dorchester, United Kingdom, DT1 1DT
Contact: Fernando Eriksson       fernando.eriksson@gmail.com   
Principal Investigator: Fernando Eriksson         
The Dentist Recruiting
London, United Kingdom, CM23 3AZ
Contact: Luigi Nibali       l.nibali@qmul.ac.uk   
Principal Investigator: Luigi Nibali         
High Barnet Dental Care Recruiting
London, United Kingdom, EN5 5UR
Contact: Luigi Nibali       l.nibali@qmul.ac.uk   
Principal Investigator: Luigi Nibali         
Pall Mall Dental Recruiting
London, United Kingdom, SW1Y 5LU
Contact: Vasiliki Koidou       vkoidou@hotmail.com   
Principal Investigator: Vasiliki Koidou         
Ravenscourt Dental Practice Recruiting
London, United Kingdom, W6 0SL
Contact: Luigi Nibali       l.nibali@qmul.ac.uk   
Principal Investigator: Luigi Nibali         
Claremont Dental Practice Recruiting
Middlesex, United Kingdom, TW1 3EJ
Contact: Olanrewaju Onabolu       onabolulanre@yahoo.com   
Principal Investigator: Olanrewaju Onabolu         
Sponsors and Collaborators
Queen Mary University of London
Ravenscourt Dental Practice
South Coast Dental Specialists
Claremonth Dental Practice
Pall Mall Dental
Rose Lane Dental Practice
Periosouth
Clinica de Periodoncia
Studio Dentistico Associato Montevecchi D' Alessandro
11th floor 141 Queen St. Brisdane
The Dentist
High Barnet Dental Care
Investigators
Layout table for investigator information
Principal Investigator: Luigi Nibali, DipDent, MSc, PhD Barts & The London School of Medicine & Dentistry, QMUL

Publications:

Layout table for additonal information
Responsible Party: Queen Mary University of London
ClinicalTrials.gov Identifier: NCT03741374     History of Changes
Other Study ID Numbers: QMERC 2018/56
First Posted: November 14, 2018    Key Record Dates
Last Update Posted: April 8, 2019
Last Verified: October 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Periodontitis
Chronic Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases