Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000054718
Ethics application status
Approved
Date submitted
13/11/2021
Date registered
18/01/2022
Date last updated
16/02/2024
Date data sharing statement initially provided
18/01/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessing the impact of the size of a maxillary sinus graft and its contact with surrounding sinus walls on bone regeneration
Scientific title
Graft contact area to volume ratio – a critical factor in new bone formation after maxillary sinus augmentation in adults?
Secondary ID [1] 305789 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
alveolar bone regeneration 324298 0
Condition category
Condition code
Oral and Gastrointestinal 321786 321786 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
70 patients included in this trial will be undergoing maxillary sinus augmentation for the purposes of dental implant rehabilitation. This procedure allows new bone formation thereby facilitating dental implant placement. The extent of new bone formation will be measured histologically and correlated to sinus graft volume and degree of contact this graft has with surrounding bone walls. The surgical procedures will be carried out by specialist clinicians (periodontists) with at more than 15 years experience in a specialist private practice. A bone sample will be collected at the time of dental implant placement (6 months after grafting surgery). Histological preparation and measurements will be performed at a university laboratory using well established protocols and an experienced scientific team. This procedure is routinely performed in patients requiring dental implant rehabilitation in the posterior maxilla in situations of insufficient bone due to maxillary sinus pneumatization. The same procedure will still be carried out when clinically indicated in patients who elect to not participate in this trial or withdraw at any time.
Intervention code [1] 322186 0
Diagnosis / Prognosis
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 329550 0
Area fraction of new bone formation - assessed histologically
Timepoint [1] 329550 0
6 months after maxillary sinus augmentation
Secondary outcome [1] 402938 0
Percentage bone graft osseointegrated - assessed histologically
Timepoint [1] 402938 0
6 months after maxillary sinus augmentation
Secondary outcome [2] 402939 0
area fraction of residual graft - assessed histologically
Timepoint [2] 402939 0
6 months after maxillary sinus augmentation
Secondary outcome [3] 402940 0
area fraction of non-mineralized tissue - assessed histologically
Timepoint [3] 402940 0
6 months after maxillary sinus augmentation
Secondary outcome [4] 402941 0
area fraction of lamellar bone - assessed histologically
Timepoint [4] 402941 0
6 months after maxillary sinus augmentation
Secondary outcome [5] 402942 0
area fraction of woven bone - assessed histologically
Timepoint [5] 402942 0
6 months after maxillary sinus augmentation

Eligibility
Key inclusion criteria
• Individuals are at least 18 years of age, medically healthy or with mild controlled systemic disease, able to undergo oral surgical procedures under local or general anaesthesia (ASA I and II; American Society of Anesthesiologists, Schaumburg, Illinois, USA).
• Adequate plaque control (FM plaque and BOP scores equal to or greater than 25%) at study baseline
• Residual alveolar bone height of the edentulous maxilla below the floor of the maxillary sinus less than or equal to 4.9 mm and equal to or greater than 3.0 mm (measured at the mid-point of the edentulous space where both the coronal and sagittal planes intersect) and residual alveolar bone width of greater than or equal to 6mm.
• If bilateral sinus augmentation was required, only one sinus was randomly selected and used for the purposes of this study.
• Teeth at the surgical site which require removal are extracted a minimum of 12 weeks prior to sinus floor elevation
• Treated and stable periodontal disease as assessed by specialist Periodontists (JA & SI) with stability defined as having a full mouth bleeding score great than 20% and no sites of residual periodontal probing depth greater than 5mm (Lang & Tonetti 2003).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Pregnancy at the time of recruitment
• Alcoholism or chronic drug abuse
• Patients who smoke more than 10 cigarettes per day
• Medications which interferes with bone formation
• History of local radiation therapy
• Severe parafunction
• Signs and symptoms consistent with acute maxillary sinusitis
• Significant soft tissue thickening (=2mm thickening) or sinus opacification in the sinus of interest.
• Previous maxillary sinus augmentation.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Descriptive statistics such as mean (± standard deviation) in addition to median (inter-quartile range) and range (minimum, maximum) as well as absolute and relative frequencies will be provided for baseline and outcome parameters. A multi-variable linear regression model will be used with the following parameters:
o Predictors: graft-to-surrounding sinus wall contact area (CA) to initial graft volume (GV) ratio
o Primary outcomes: faction new bone (%NB)
o Secondary outcomes: remaining bone graft fractions (%WB, LB, RG, ST, OI)
o Control for age, gender, medical status, periodontal status

The null hypothesis was taken as no correlation between the ratio CA: GV and %NB regenerated after staged MSA in the apical third region of the graft. A P = 0.05 was considered to represent statistically significant differences.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/02/2022
Actual
13/03/2023
Date of last participant enrolment
Anticipated
31/12/2024
Actual
Date of last data collection
Anticipated
30/06/2025
Actual
Sample size
Target
50
Accrual to date
38
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 310144 0
University
Name [1] 310144 0
University of Queensland
Country [1] 310144 0
Australia
Funding source category [2] 310145 0
University
Name [2] 310145 0
University of Queensland
Country [2] 310145 0
Australia
Primary sponsor type
University
Name
University of Queensland
Address
Herston Road
Herston QLD 4006
Country
Australia
Secondary sponsor category [1] 311219 0
None
Name [1] 311219 0
Address [1] 311219 0
Country [1] 311219 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309833 0
University of Queensland Human Research Ethics Committee
Ethics committee address [1] 309833 0
Ethics committee country [1] 309833 0
Australia
Date submitted for ethics approval [1] 309833 0
13/11/2021
Approval date [1] 309833 0
08/03/2023
Ethics approval number [1] 309833 0
2021/HE002120

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

Contacts
Principal investigator
Name 115542 0
Dr jamil alayan
Address 115542 0
University of Queensland
Herston Road
Hertston QLD 4006
Country 115542 0
Australia
Phone 115542 0
+61733658022
Fax 115542 0
Email 115542 0
[email protected]
Contact person for public queries
Name 115543 0
jamil alayan
Address 115543 0
University of Queensland
Herston Road
Hertston QLD 4006
Country 115543 0
Australia
Phone 115543 0
+61733658022
Fax 115543 0
Email 115543 0
[email protected]
Contact person for scientific queries
Name 115544 0
jamil alayan
Address 115544 0
University of Queensland
Herston Road
Hertston QLD 4006
Country 115544 0
Australia
Phone 115544 0
+61733658022
Fax 115544 0
Email 115544 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Only group data will be presented rather than individual participant data


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.