Trial Review

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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03741374
Ethics application status
Date submitted
5/11/2018
Date registered
14/11/2018
Date last updated
18/12/2023

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
Timepoint [1] 0 0
12 months
Secondary outcome [1] 0 0
Probing Pocket Depth change
Timepoint [1] 0 0
12 months
Secondary outcome [2] 0 0
Clinical Attachment Level change
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
Sex
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
NA
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
NA
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
1/02/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/04/2025
Actual
Sample size
Target
100
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
Trial website
Trial related presentations / publications
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
[email protected]
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT03741374