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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03741374




Registration number
NCT03741374
Ethics application status
Date submitted
5/11/2018
Date registered
14/11/2018
Date last updated
27/01/2020

Titles & IDs
Public title
Minimally-invasive Non-surgical Therapy of Intrabony Defects
Scientific title
Analysis of Intrabony Defects Treated With Minimally-invasive Non-surgical Therapy: A Prospective Cohort Multicentre Study
Secondary ID [1] 0 0
QMERC 2018/56
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Periodontitis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Minimally-invasive non-surgical therapy (MINST)

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


Treatment: Surgery: 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.

Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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)]
Timepoint [1] 0 0
12 months
Secondary outcome [1] 0 0
Probing Pocket Depth change - Probing Pocket Depth (PPD) change (in mm) at 12 months
Timepoint [1] 0 0
12 months
Secondary outcome [2] 0 0
Clinical Attachment Level change - Clinical Attachment Level (CAL) change at 12 months
Timepoint [2] 0 0
12 months

Eligibility
Key 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].
Minimum age
18 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key 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).

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Dr Ryan Lee Private Practice - Brisbane
Recruitment postcode(s) [1] 0 0
QLD 4000 - Brisbane
Recruitment outside Australia
Country [1] 0 0
Italy
State/province [1] 0 0
Forlimpopoli
Country [2] 0 0
Spain
State/province [2] 0 0
Coruna
Country [3] 0 0
United Kingdom
State/province [3] 0 0
Dorchester
Country [4] 0 0
United Kingdom
State/province [4] 0 0
London
Country [5] 0 0
United Kingdom
State/province [5] 0 0
Middlesex

Funding & Sponsors
Primary sponsor type
Other
Name
Queen Mary University of London
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Ravenscourt Dental Practice
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
South Coast Dental Specialists
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Claremonth Dental Practice
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Pall Mall Dental
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
Rose Lane Dental Practice
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
Periosouth
Address [6] 0 0
Country [6] 0 0
Other collaborator category [7] 0 0
Other
Name [7] 0 0
Clinica de Periodoncia
Address [7] 0 0
Country [7] 0 0
Other collaborator category [8] 0 0
Other
Name [8] 0 0
Studio Dentistico Associato Montevecchi D' Alessandro
Address [8] 0 0
Country [8] 0 0
Other collaborator category [9] 0 0
Other
Name [9] 0 0
11th floor 141 Queen St. Brisdane
Address [9] 0 0
Country [9] 0 0
Other collaborator category [10] 0 0
Other
Name [10] 0 0
The Dentist
Address [10] 0 0
Country [10] 0 0
Other collaborator category [11] 0 0
Other
Name [11] 0 0
High Barnet Dental Care
Address [11] 0 0
Country [11] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This investigation aims to assess the clinical and radiographic outcomes of intrabony defects
treated with minimally-invasive non-surgical therapy.
Trial website
https://clinicaltrials.gov/show/NCT03741374
Trial related presentations / publications
Papapanou PN, Tonetti MS. Diagnosis and epidemiology of periodontal osseous lesions. Periodontol 2000. 2000 Feb;22:8-21. Review.
Papapanou PN, Wennström JL. The angular bony defect as indicator of further alveolar bone loss. J Clin Periodontol. 1991 May;18(5):317-22.
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. Review.
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.
Cortellini P, Tonetti MS. Focus on intrabony defects: guided tissue regeneration. Periodontol 2000. 2000 Feb;22:104-32. Review.
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. Review. Update in: Cochrane Database Syst Rev. 2019 May 29;5:CD001724.
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 .
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.
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.
Ribeiro FV, Casarin RC, Palma MA, Júnior 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.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Luigi Nibali, DipDent, MSc, PhD
Address 0 0
Barts & The London School of Medicine & Dentistry, QMUL
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Luigi Nibali, DipDent, MSc, PhD
Address 0 0
Country 0 0
Phone 0 0
+44(0)2078823134
Fax 0 0
Email 0 0
l.nibali@qmul.ac.uk
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03741374