Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000040268
Ethics application status
Approved
Date submitted
12/12/2017
Date registered
15/01/2018
Date last updated
20/06/2022
Date data sharing statement initially provided
28/01/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Impact of Alveolar Ridge Preservation on Implant Supported Restorations
Scientific title
The Impact Of Alveolar Ridge Preservation In Buccal Wall Dehiscence Defects & Intact Socket Walls On Surgical & Prosthetic Outcomes In Implant Supported Restorations
Secondary ID [1] 293595 0
nil
Universal Trial Number (UTN)
U1111-1206-5614
Trial acronym
ARP vs. USH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
oral tissue deficiency 305850 0
partial edentulism 305851 0
Condition category
Condition code
Oral and Gastrointestinal 305060 305060 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Alveolar ridge preservation (ARP): upon extraction, an alveolar ridge preservation procedure is performed using anorganic bovine bone mineral stabilized in 10% porcine type-1 collagen matrix (ABBM-C) (Bio-Oss Collagen®) and covered with a type 1 and 3 non-cross linked porcine collagen matrix seal (CMS) (Mucograft Seal®). Implant placement will take place 12 weeks later. All surgical interventions will be administered by a specialist periodontist.

Intervention code [1] 299853 0
Treatment: Devices
Comparator / control treatment
Unassisted socket healing (USH): no treatment is carried out after extraction. Subsequent implant placement will take place 8 weeks later.
Control group
Active

Outcomes
Primary outcome [1] 304225 0
Volumetric ridge changes as measured using a 3D intra-oral scan at various time points
Timepoint [1] 304225 0
o Pre-extraction (T-1)
o Pre-implant placement (T1)
o Delivery of the implant supported restoration (T2)
o 12 months post-placement of restoration (T3)
Primary outcome [2] 304303 0
Linear topographical ridge changes as measured using a 3D intra-oral scan at various time points
Timepoint [2] 304303 0
Pre-extraction (T-1)
o Pre-implant placement (T1)
o Delivery of the implant supported restoration (T2)
o 12 months post-placement of restoration (T3)
Secondary outcome [1] 341295 0
Radiographic: linear socket changes as measured using cone beam computed topography (CBCT) scans
Timepoint [1] 341295 0
o Immediately post-extraction (T0)
o Pre-implant placement (T1)
o Delivery of the implant supported restoration (T2)
o 12 months post-placement of restoration (T3)
Secondary outcome [2] 341296 0
Clinical - implant and implant restoration success criteria:
- assessment of peri-implant tissue attachment using periodontal probe
- assessment of crestal alveolar bone levels using standard intra-oral radiogrpahy,
- visual assessment of peri-implant tissue inflammation / infection
- asses reports of pain / dysaesthesia
- technical complications with implant supported restorations such as fractures and loosening
Timepoint [2] 341296 0
1. Immediately post-restoration insertion (within 8 weeks of insertion of restoration)
2. After 12 months of function (12 months after insertion of restoration)
Secondary outcome [3] 341297 0
Implant restoration aesthetics using an aesthetic index
Timepoint [3] 341297 0
1. Immediately post-restoration insertion (within 8 weeks of insertion of restoration)
2. After 12 months of function (12 months after insertion of restoration)
Secondary outcome [4] 341527 0
Implant restoration aesthetics as a patient reported outcome measure (PROM) using a 100mm visual analogue scale
Timepoint [4] 341527 0
1. Immediately post-restoration insertion (within 8 weeks of insertion of restoration)
2. After 12 months of function (12 months after insertion of restoration)
Secondary outcome [5] 341528 0
Average post-operative pain as a patient reported outcome measure (PROM) using a 100mm visual analogue scale
Timepoint [5] 341528 0
1st 7 days after extraction
Secondary outcome [6] 341529 0
Average post-operative interference to daily activities as a patient reported outcome measure (PROM) using a 100mm visual analogue scale
Timepoint [6] 341529 0
1st 7 days after extraction

Eligibility
Key inclusion criteria
• Over 18 years of age, medically healthy or mild controlled systemic disease
• Required the replacement of single tooth in the anterior maxilla with an implant supported restoration and was bounded by natural teeth.
• The tooth is in-vivo
• No evidence of acute infection
• Implant primary stability can be achieved using an early implant placement protocol
• Adequate plaque control (full mouth plaque and bleeding on probing (BOP) scores less than or equal to 25%).
• Treated periodontal disease deemed to be stable and patients are enrolled into a supportive periodontal program.
Minimum age
19 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Advanced buccal wall defects
• Required multiple implant replacement either adjacent or part of a multi-unit implant supported restoration
• Less than 2mm of gingival tissue height on the buccal aspect
• A systemic medical condition that could interfere with surgical procedure or negatively impact bone turnover
• Pregnancy at the time of recruitment
• A physical handicap that would interfere with the ability to perform adequate oral hygiene
• Self-reported smoking of more than 10 cigarettes per day
• A reported history of local radiation therapy
• Untreated / unstable periodontal disease

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)
permuted block randomization
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
To detect a mean difference in buccal horizontal topographical ridge change of 0.5mm, a power analysis (G*Power 3.1.9, Faul, F., Erdfelder, E., Lang, A.-G., & Bychnner, A, Germany) indicated we would need 17 individuals in each group (total study population = 34 patients) to achieve a power of 0.81 with a probability of 0.05 for type 1(alpha) errors, using a standard deviation of 0.5mm (Schneider, et al. 2014). The sample was increased to 45 individuals in each group since a multivariable linear regression model will be used to assess the impact of 3 predictors (treatment, gingival biotype and baseline buccal wall thickness or presence /absence buccal wall defect) on various treatment outcomes (Stevens 2002). Assuming a drop-out rate of 10% then 50 individuals in each group would be needed (total study population = 100 patients).

Baseline parameters such as age, socket and ridge dimensions were compared using an independent t-test and categorical parameters such as gender, smoking, periodontal status and gingival biotype were compared using a Chi square test. Surgical complications after implant placement were analyzed using a comparison of proportions. An independent t-test will be used to compare linear and volumetric changes from both CBCT and IOS in addition to all PROMs reported using VAS and peri-implant parameters (PPD, recession, interproximal bone levels). %BOP and PI will be compared using a Chi square test. A Fishers Exact test was used for comparing success criteria and technical complications.

A multivariable linear regression model will be used to assess the impact of treatment (ARF vs. USH), baseline buccal wall thickness and gingival biotype (thick vs. thin) on peri-implant defects, PES/WES, and volumetric ridge changes.

The null hypothesis was taken as no difference in topographical ridge changes or in surgical, aestheitc, and peri-implant outcomes around dental implants placed into USH sites using an early placement protocol when compared to those placed into sites receiving ARP. A P = 0.05 was considered to represent statistically significant differences.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/02/2020
Actual
1/09/2020
Date of last participant enrolment
Anticipated
31/12/2022
Actual
Date of last data collection
Anticipated
30/06/2024
Actual
Sample size
Target
100
Accrual to date
10
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 18295 0
4000 - Brisbane Adelaide Street

Funding & Sponsors
Funding source category [1] 298213 0
Commercial sector/Industry
Name [1] 298213 0
Geistlich AG
Country [1] 298213 0
Switzerland
Funding source category [2] 298285 0
Commercial sector/Industry
Name [2] 298285 0
Straumann
Country [2] 298285 0
Switzerland
Primary sponsor type
University
Name
University of Queensland
Address
288 Herston Road
Herston QLD 4006
Country
Australia
Secondary sponsor category [1] 297316 0
None
Name [1] 297316 0
Address [1] 297316 0
Country [1] 297316 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299221 0
University of Queensland Human Research and Ethics Committee
Ethics committee address [1] 299221 0
Ethics committee country [1] 299221 0
Australia
Date submitted for ethics approval [1] 299221 0
01/01/2020
Approval date [1] 299221 0
05/03/2020
Ethics approval number [1] 299221 0

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

Contacts
Principal investigator
Name 79702 0
Dr Jamil Alayan
Address 79702 0
Brisbane City Periodontics and Implants
Jamil Alayan
Level 20
141 Queen Street
Brisbane QLD 4000
Country 79702 0
Australia
Phone 79702 0
+61732219363
Fax 79702 0
Email 79702 0
[email protected]
Contact person for public queries
Name 79703 0
Jamil Alayan
Address 79703 0
Brisbane City Periodontics and Implants
Jamil Alayan
Level 20
141 Queen Street
Brisbane QLD 4000
Country 79703 0
Australia
Phone 79703 0
+61732219363
Fax 79703 0
Email 79703 0
[email protected]
Contact person for scientific queries
Name 79704 0
Jamil Alayan
Address 79704 0
Brisbane City Periodontics and Implants
Jamil Alayan
Level 20
141 Queen Street
Brisbane QLD 4000
Country 79704 0
Australia
Phone 79704 0
+61732219363
Fax 79704 0
Email 79704 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
Group data is relevant


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.