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Minimally-invasive Non-surgical Therapy of Intrabony Defects

Primary Purpose

Chronic Periodontitis

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Minimally-invasive non-surgical therapy (MINST)
Sponsored by
Queen Mary University of London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Periodontitis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • Dr Ryan Lee Private PracticeRecruiting
  • Studio Dentistico Associato Montevecchi D'Alessandro
  • Clinica de Periodoncia
  • South Coast Dental Specialists
  • The DentistRecruiting
  • High Barnet Dental CareRecruiting
  • Pall Mall DentalRecruiting
  • Ravenscourt Dental PracticeRecruiting
  • Claremont Dental PracticeRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Minimally-invasive non-surgical therapy

Arm Description

Intrabony defects treated with Minimally-invasive non-surgical therapy (MINST)

Outcomes

Primary Outcome Measures

Radiographic whole defect depth reduction
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

Probing Pocket Depth change
Probing Pocket Depth (PPD) change (in mm) at 12 months
Clinical Attachment Level change
Clinical Attachment Level (CAL) change at 12 months

Full Information

First Posted
November 5, 2018
Last Updated
May 25, 2023
Sponsor
Queen Mary University of London
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
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1. Study Identification

Unique Protocol Identification Number
NCT03741374
Brief Title
Minimally-invasive Non-surgical Therapy of Intrabony Defects
Official Title
Analysis of Intrabony Defects Treated With Minimally-invasive Non-surgical Therapy: A Prospective Cohort Multicentre Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
April 2025 (Anticipated)
Study Completion Date
April 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Queen Mary University of London
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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic 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
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Minimally-invasive non-surgical therapy
Arm Type
Experimental
Arm Description
Intrabony defects treated with Minimally-invasive non-surgical therapy (MINST)
Intervention Type
Procedure
Intervention Name(s)
Minimally-invasive non-surgical therapy (MINST)
Intervention Description
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 Measure Information:
Title
Radiographic whole defect depth reduction
Description
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)]
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Probing Pocket Depth change
Description
Probing Pocket Depth (PPD) change (in mm) at 12 months
Time Frame
12 months
Title
Clinical Attachment Level change
Description
Clinical Attachment Level (CAL) change at 12 months
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age 18-70 Diagnosis of Periodontitis (Tonetti et al. 2018) 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) 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: Smoking (current or in past 5 years, including electronic cigarettes, vaping or similar) Medical history including diabetes or hepatic or renal disease, or other serious medical conditions or transmittable diseases Presence of drug-induced gingival enlargement 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, Taking immunosuppressant medications Known allergy to local anaesthetic History of alcohol or drug abuse 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 (excluding not-extensive subgingival debridement as judged by the examining clinician).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Luigi Nibali, DipDent, MSc, PhD
Phone
+44(0)2078823134
Email
l.nibali@qmul.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Vandana Luthra, Dr.
Phone
02078826348
Email
BHNT.Clinicaloralresearchcentre@nhs.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luigi Nibali, DipDent, MSc, PhD
Organizational Affiliation
Barts & The London School of Medicine & Dentistry, QMUL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr Ryan Lee Private Practice
City
Brisbane
ZIP/Postal Code
QLD 4000
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ryan Lee
Email
r.sblee@uq.edu.au
First Name & Middle Initial & Last Name & Degree
Ryan Lee
Facility Name
Studio Dentistico Associato Montevecchi D'Alessandro
City
Forlimpopoli
ZIP/Postal Code
47034
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marco Montevecchi
Email
m.montevecchi@unibo.it
First Name & Middle Initial & Last Name & Degree
Marco Montevecchi
Facility Name
Clinica de Periodoncia
City
Coruna
ZIP/Postal Code
15003
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonio Linares
Email
antonio@antoniolinares.com
First Name & Middle Initial & Last Name & Degree
Antonio Linares
Facility Name
South Coast Dental Specialists
City
Dorchester
ZIP/Postal Code
DT1 1DT
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fernando Eriksson
Email
fernando.eriksson@gmail.com
First Name & Middle Initial & Last Name & Degree
Fernando Eriksson
Facility Name
The Dentist
City
London
ZIP/Postal Code
CM23 3AZ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luigi Nibali
Email
l.nibali@qmul.ac.uk
First Name & Middle Initial & Last Name & Degree
Luigi Nibali
Facility Name
High Barnet Dental Care
City
London
ZIP/Postal Code
EN5 5UR
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luigi Nibali
Email
l.nibali@qmul.ac.uk
First Name & Middle Initial & Last Name & Degree
Luigi Nibali
Facility Name
Pall Mall Dental
City
London
ZIP/Postal Code
SW1Y 5LU
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vasiliki Koidou
Email
vkoidou@hotmail.com
First Name & Middle Initial & Last Name & Degree
Vasiliki Koidou
Facility Name
Ravenscourt Dental Practice
City
London
ZIP/Postal Code
W6 0SL
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luigi Nibali
Email
l.nibali@qmul.ac.uk
First Name & Middle Initial & Last Name & Degree
Luigi Nibali
Facility Name
Claremont Dental Practice
City
Middlesex
ZIP/Postal Code
TW1 3EJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olanrewaju Onabolu
Email
onabolulanre@yahoo.com
First Name & Middle Initial & Last Name & Degree
Olanrewaju Onabolu

12. IPD Sharing Statement

Citations:
PubMed Identifier
11276518
Citation
Papapanou PN, Tonetti MS. Diagnosis and epidemiology of periodontal osseous lesions. Periodontol 2000. 2000 Feb;22:8-21. doi: 10.1034/j.1600-0757.2000.2220102.x. No abstract available.
Results Reference
background
PubMed Identifier
2066446
Citation
Papapanou PN, Wennstrom JL. The angular bony defect as indicator of further alveolar bone loss. J Clin Periodontol. 1991 May;18(5):317-22. doi: 10.1111/j.1600-051x.1991.tb00435.x.
Results Reference
background
PubMed Identifier
12787211
Citation
Heitz-Mayfield LJ, Trombelli L, Heitz F, Needleman I, Moles D. A systematic review of the effect of surgical debridement vs non-surgical debridement for the treatment of chronic periodontitis. J Clin Periodontol. 2002;29 Suppl 3:92-102; discussion 160-2. doi: 10.1034/j.1600-051x.29.s3.5.x.
Results Reference
background
PubMed Identifier
6964676
Citation
Nyman S, Lindhe J, Karring T, Rylander H. New attachment following surgical treatment of human periodontal disease. J Clin Periodontol. 1982 Jul;9(4):290-6. doi: 10.1111/j.1600-051x.1982.tb02095.x.
Results Reference
background
PubMed Identifier
11276509
Citation
Cortellini P, Tonetti MS. Focus on intrabony defects: guided tissue regeneration. Periodontol 2000. 2000 Feb;22:104-32. doi: 10.1034/j.1600-0757.2000.2220108.x. No abstract available.
Results Reference
background
PubMed Identifier
16625546
Citation
Needleman IG, Worthington HV, Giedrys-Leeper E, Tucker RJ. Guided tissue regeneration for periodontal infra-bony defects. Cochrane Database Syst Rev. 2006 Apr 19;(2):CD001724. doi: 10.1002/14651858.CD001724.pub2.
Results Reference
background
PubMed Identifier
19186978
Citation
Trombelli L, Farina R, Franceschetti G, Calura G. Single-flap approach with buccal access in periodontal reconstructive procedures. J Periodontol. 2009 Feb;80(2):353-60. doi: 10.1902/jop.2009.080420.
Results Reference
background
PubMed Identifier
21303402
Citation
Cortellini P, Tonetti MS. Clinical and radiographic outcomes of the modified minimally invasive surgical technique with and without regenerative materials: a randomized-controlled trial in intra-bony defects. J Clin Periodontol. 2011 Apr;38(4):365-73. doi: 10.1111/j.1600-051X.2011.01705.x. Epub 2011 Feb 8.
Results Reference
background
PubMed Identifier
21091528
Citation
Nibali L, Pometti D, Tu YK, Donos N. Clinical and radiographic outcomes following non-surgical therapy of periodontal infrabony defects: a retrospective study. J Clin Periodontol. 2011 Jan;38(1):50-7. doi: 10.1111/j.1600-051X.2010.01648.x. Epub 2010 Nov 22.
Results Reference
background
PubMed Identifier
21284549
Citation
Ribeiro FV, Casarin RC, Palma MA, Junior FH, Sallum EA, Casati MZ. Clinical and patient-centered outcomes after minimally invasive non-surgical or surgical approaches for the treatment of intrabony defects: a randomized clinical trial. J Periodontol. 2011 Sep;82(9):1256-66. doi: 10.1902/jop.2011.100680. Epub 2011 Feb 2.
Results Reference
background
PubMed Identifier
26257238
Citation
Nibali L, Pometti D, Chen TT, Tu YK. Minimally invasive non-surgical approach for the treatment of periodontal intrabony defects: a retrospective analysis. J Clin Periodontol. 2015 Sep;42(9):853-859. doi: 10.1111/jcpe.12443. Epub 2015 Sep 29.
Results Reference
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Minimally-invasive Non-surgical Therapy of Intrabony Defects

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