Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
St Lucia 4072
QLD
Australia
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
The aim of this RCT is to determine if there are any benefits of placing dental implants into sites that have previously received alveolar ridge preservation (ARP) when compared to conventional implant placement protocol. This study will be carried out on patients recruited from a specialist clinical practice who are referred for single implant replacement in the aesthetic zone (teeth 13-to-23) and who meet the inclusion criteria.
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
Dr 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
Dr 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.