Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000497909
Ethics application status
Approved
Date submitted
20/03/2020
Date registered
20/04/2020
Date last updated
9/08/2023
Date data sharing statement initially provided
20/04/2020
Date results provided
9/08/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of grafting with dental biomaterials on the tooth-supporting tissues surrounding lower second molars following removal of impacted third molars in healthy young adults
Scientific title
Bio-Oss Collagen grafting and the periodontal attachment effects following extraction of mesioangular, impacted third molars in medically healthy and periodontally sound 18 - 35 year old adults.
Secondary ID [1] 300834 0
None
Universal Trial Number (UTN)
U1111-1250-0467
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Loss of periodontal attachment on distal aspect of mandibular second molar as a result of an impacted third molar 316722 0
Condition category
Condition code
Oral and Gastrointestinal 314966 314966 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Tooth extraction and ridge preservation will be performed by the specialist oral and maxillofacial surgeon (under local or general anaesthesia) using a minimally traumatic approached aimed to preserve an intact buccal bony cortex. If necessary, roots will be sectioned with a bur and removed separately to minimize damage to the bony cortex. Careful curettage of the socket will be performed to remove all bony and tooth debris and infective tissue and exposed tooth structure of the adjacent tooth will be debrided. It is anticipated that extracting both third molars will take approximately 45 minutes of surgical time. Once both third mandibular third molars have been removed, the surgeon will then open a sealed envelope indicating which side (left or right) is receiving the grafting procedure (test site) and which site is receiving no additional treatment (control site).

In test sites, the extraction socket will be grafted with Bio-Oss Collagen which will be firmly compacted and secured against the exposed root, cemento-enamel junction and approximately one millimetre above the junction. This will take approximately one minute of surgical time and the study intervention is completed at this time.

Both test and control sites will be closed by primary flap closure where possible and secured with sutures.

The surgeon will discuss post-operative antibiotic and analgesic therapy with each patient. Subjects will be instructed to avoid rinsing and spitting for the first twenty-four hours. Subjects will be advised to use zero-point two percent chlorhexidine mouth wash for rinsing twice daily and to avoid brushing directly on the surgical site for one week. Subjects will be advised to maintain a soft diet for two weeks. Patients will be reviewed in approximately two weeks (or similar timeframe as required by the surgeon) and sutures will be removed. Any incidence of postoperative complications will be recorded and can be compared between control and test groups.

Final clinical and radiographic measures will be taken six months after the surgery.
Intervention code [1] 317161 0
Treatment: Surgery
Intervention code [2] 317204 0
Treatment: Devices
Comparator / control treatment
The control treatment is no treatment. Both test and control sites will receive the clinically necessary extractions and primary flap closure as per the inclusion criteria. Experimentally, test sites are receiving grafting with Bio-Oss Collagen and control sites are receiving nothing.
Control group
Active

Outcomes
Primary outcome [1] 323277 0
A primary outcome measure will be the linear measurements between the cemento-enamel junction and the alveolar bone crest on the distal aspect of the second molar on the cone beam CT scan.
Timepoint [1] 323277 0
6 months after the extractions
Primary outcome [2] 335706 0
A primary outcome measure will be volumetric bone infill measurements on the cone beam CT scan.
Timepoint [2] 335706 0
6 months after the extraction
Secondary outcome [1] 381409 0
Bleeding on probing between test and control sites. This will be measured by probing the periodontal pockets and waiting 15 seconds. A scoring system of 1 (present) and 0 (absent) will be used to measure bleeding on probing
Timepoint [1] 381409 0
6 months after the extraction
Secondary outcome [2] 381410 0
The probing pocket depths between test and control sites six months after healing. This will be assessed by periodontal probes.
Timepoint [2] 381410 0
6 months after the extractions
Secondary outcome [3] 381411 0
Patient reported outcomes: measuring pain levels between test and control sites on the visual analogue scale
Timepoint [3] 381411 0
6 months after the extraction
Secondary outcome [4] 381546 0
patient reported outcomes: measuring patient level satisfaction on the patient satisfaction questionnaire.
Timepoint [4] 381546 0
6 months post-operatively

Eligibility
Key inclusion criteria
• One or two unerupted mandibular third molars that are Class I or II and Position B or C on the Pell and Gregory scale with a Horizontal or Mesioangular (10-80 degrees) of the Winter classification
• Evidence of radiographic bone loss of more than 5mm from the cementoenamel junction to the crest of the alveolar bone on the distal aspect of the distal root of the adjacent second molar at time of initial examination due to an impacted wisdom tooth
• Able to tolerate extraction procedure: surgeon will determine this parameter
• Medically fit and well. Classified as American Society of Anaesthesiologist (ASA) Class I patient as a normal, healthy patient. (no medical illness e.g. diabetes, not smoking, low alcohol intake)
• Aged 18 – 45 years old
Minimum age
18 Years
Maximum age
35 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Impacted third molars that are disto-angular impacted or require extensive surgery
• Patient has a history of diagnosed periodontitis disease (more than 2mm of clinical attachment loss)
• Patient currently has periodontal disease in any aspect of the mouth except periodontal breakdown associated with impacted third molars (mandibular or maxillary)
• Patient has lost more than 2mm of clinical attachment due to non-periodontal reasons
• Pathology that requires more than just extraction and primary wound closure
• Plaque index of 40% or more (indicating poor oral hygiene)
• Patients unwilling to return for all periodontal review appointment

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Enrollment into the test or control sites will be based on randomisation sequences. For patients with two eligible sites, one will be enrolled as a test site and the other will be a control site. This will be done according to the randomisation sequence.
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size calculations: As the primary outcome variable is linear radiographic measurements from the cemento-enamel junction to the bone crest, on the cone beam CT an effect size of 1.5mm was deemed clinically significant. Considering that the physiological bone level is at most 2mm from the cemento-enamel junction, a 5mm measurement from the cemento-enamel junction to the bone crest, which is characteristic of the included population, is consistent with 3mm of pathological bone loss. Consequently an effect size of 1.5mm is concurrent with an additional 50% resolution of the pathological bony defect.

Calculating the sample size with an alpha error of 0.05 and power of 0.90 resulted in a sample size of 9 sites in each group, assuming that the data will be normally distributed. To account for subject drop-outs and the chance that the data will not be normally distributed, we will target 18 sites per group. As such, the maximum number of patients that will be recruited is 36 or 18 sites per group.

At the 6 month review, ANOVA tests will be used to compare means between and within test and control groups at the beginning and end of the trial.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2020
Actual
1/08/2020
Date of last participant enrolment
Anticipated
31/12/2022
Actual
30/06/2022
Date of last data collection
Anticipated
30/06/2023
Actual
13/01/2023
Sample size
Target
36
Accrual to date
Final
42
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 29681 0
4305 - Ipswich
Recruitment postcode(s) [2] 29682 0
4122 - Mount Gravatt
Recruitment postcode(s) [3] 29684 0
4064 - Milton
Recruitment postcode(s) [4] 34345 0
4066 - Auchenflower
Recruitment postcode(s) [5] 34346 0
4109 - Sunnybank

Funding & Sponsors
Funding source category [1] 305292 0
Commercial sector/Industry
Name [1] 305292 0
Geitslich Pharma Australia
Country [1] 305292 0
Australia
Primary sponsor type
University
Name
The University Of Queensland
Address
School of Dentistry
Oral Health Centre Herston
288 Herston Rd,
Herston QLD 4006
Country
Australia
Secondary sponsor category [1] 305652 0
None
Name [1] 305652 0
Address [1] 305652 0
Country [1] 305652 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308734 0
University of Queensland Human Ethics Committee A
Ethics committee address [1] 308734 0
Ethics committee country [1] 308734 0
Australia
Date submitted for ethics approval [1] 308734 0
05/03/2020
Approval date [1] 308734 0
05/05/2020
Ethics approval number [1] 308734 0
2020000215

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 101018 0
Dr Su Sheng Quach
Address 101018 0
Periodontics Department, School of Dentistry
The University of Queensland
288 Herston Rd
Herston QLD 4006
Country 101018 0
Australia
Phone 101018 0
+61425861499
Fax 101018 0
Email 101018 0
[email protected]
Contact person for public queries
Name 101019 0
Su Sheng Quach
Address 101019 0
Periodontics Department, School of Dentistry
The University of Queensland
288 Herston Rd
Herston QLD 4006
Country 101019 0
Australia
Phone 101019 0
+61425861499
Fax 101019 0
Email 101019 0
[email protected]
Contact person for scientific queries
Name 101020 0
Su Sheng Quach
Address 101020 0
Periodontics Department, School of Dentistry
The University of Queensland
288 Herston Rd
Herston QLD 4006
Country 101020 0
Australia
Phone 101020 0
+61425861499
Fax 101020 0
Email 101020 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
all of the individual participant data collected during the trial, after de-identification
When will data be available (start and end dates)?
Immediately following publication, for 6 months
Available to whom?
only researchers who provide a methodologically sound proposal
Available for what types of analyses?
to achieve the aims in the approved proposal and for IPD meta-analyses
How or where can data be obtained?
access subject to approvals by Principal Investigator (email: [email protected])


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.