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Trial registered on ANZCTR


Registration number
ACTRN12619000526178
Ethics application status
Approved
Date submitted
19/03/2019
Date registered
2/04/2019
Date last updated
22/04/2020
Date data sharing statement initially provided
2/04/2019
Date results information initially provided
2/04/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Biological & technical outcomes of restored implants after maxillary sinus augmentation using xenograft / autogenous bone & collagen-stabilized xenograft – results at 1 year loading
Scientific title
Biological & technical outcomes of restored implants after maxillary sinus augmentation using xenograft / autogenous bone & collagen-stabilized xenograft – results at 1 year loading
Secondary ID [1] 297751 0
nil
Universal Trial Number (UTN)
U1111-1230-3509
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
outcomes of maxillary Sinus augmentation 312083 0
Outcomes of restored dental Implants in maxillary sinus augmentation 312186 0
Condition category
Condition code
Oral and Gastrointestinal 310645 310645 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
2 arm non-randomized clinical trial comparing outcomes of implant supported restorations when placed into previously lateral wall augmented maxillary sinuses (MSA)
(treatment groups) both groups received the same tissue level SLA dental implant.
Test group - collagen stabilized anorganic bovine bone mineral (ABBM-C)
Control group: composite graft of anorganic bovine bone mineral (ABBM) and autogenous bone
(Intervention) lateral wall maxillary sinuse augmentation then dental implant placement and finally restoration.
(clinician performing intervention) specialist Periodontist
(type of intervention) clinical / surgical
(No. of times intervention carried out) Once. Outcomes of the dental implants measured after 1 year and then after 5 years of function
(location) private practice - level 1 141 Queen street Brisbane QLD 4000
(g) NA
MSA - 2hrs
Implant placement - 1hr
Restoration - 1hr
Review - 30min

2. Treatment allocation was based on defined clinical scenarios - reduced local autogenous bone availability and/or sinus membrane perforation received ABBM-C.
Intervention code [1] 313988 0
Treatment: Surgery
Comparator / control treatment
outcomes of restored dental implants after placed into augmented maxillary sinuses using a composite graft of anorganic bovine bone mineral (ABBM) and autogenous bone
Control group
Active

Outcomes
Primary outcome [1] 319491 0
radiographic assessment of interproximal marginal bone levels (DIB)
Timepoint [1] 319491 0
1 year after delivery of prosthesis
5 years after delivery of prosthesis
Secondary outcome [1] 368418 0
Peri-implant tissue health assessment - composite (includes probing depth, gingival recession, bleeding on probing, plaque index). Assessed by clinical examination.

Timepoint [1] 368418 0
12 months after prosthesis delivery
5 years after delivery of prosthesis
Secondary outcome [2] 368419 0
Implant supported restoration assessment - composite
Assessed by clinical examination.
Timepoint [2] 368419 0
12 months after prosthesis delivery
5 years after delivery of prosthesis
Secondary outcome [3] 368420 0
Dental implant survival. Assessed by clinical examination.
Timepoint [3] 368420 0
12 months after prosthesis delivery
5 years after delivery of prosthesis
Secondary outcome [4] 368683 0
Implant restoration survival. Assessed by clinical examination.
Timepoint [4] 368683 0
12 months after prosthesis delivery
5 years after delivery of prosthesis
Secondary outcome [5] 368802 0
Maxillary sinus graft stability
Timepoint [5] 368802 0
5 years after delivery of prosthesis assessed by radiographically

Eligibility
Key inclusion criteria
• Individuals were 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).
• Must present with a bone deficiency in the maxillary sinus region, which necessitates sinus floor augmentation
• If bilateral sinus augmentation was required, only one sinus was randomly selected and used for the purposes of this study.
• Residual alveolar bone height of the edentulous maxilla below the floor of the maxillary sinus: less than or equal to 4.5 mm and greater than or equal to 1 mm (measured at the mid-point of the edentulous space where both the coronal and sagittal planes intersect) and residual alveolar bone width of equal to or greater than 6mm.
• Teeth at the surgical site which required removal were extracted a minimum of 12 weeks prior to sinus floor elevation
• Patients with a history of periodontal disease as assessed by specialist Periodontists (JA & SI) and according to the criteria of Armitage (Armitage 1999) were treated and deemed to be stable prior to sinus augmentation surgery. Stability was defined as having a full mouth bleeding score of equal to or less than 20% and no sites of residual periodontal probing depth of less than and equal to 5mm (Lang & Tonetti 2003).
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Pregnancy at the time of recruitment
• Physical handicaps that interfere with the ability to perform adequate oral hygiene
• Alcoholism or chronic drug abuse
• Patients who smoke more than 10 cigarettes per day
• Medications which interferes with bone formation
• Mucosal diseases such as Lichen Planus
• History of local radiation therapy
• Severe bruxism or clenching habits
• Signs and symptoms consistent with acute maxillary sinusitis
• Significant soft tissue thickening or sinus opacification in the sinus of interest.
• Previous bone augmentation or dental implant placement in the posterior maxilla
• Benign or malignant tumours of the maxillary sinus
• Pathological conditions that severely impact mucociliary clearance including; Chronic sinusitis, Primary Ciliary Dyskinesia or Cystic Fibrosis.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
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
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Measurement of radiographic bone levels was masked
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The patients in this study were part of a larger study designed to have sufficient statistical power to detect differences in maxillary sinus graft volume between the two groups (Alayan & Ivanovski 2018). Nonetheless, an analysis was performed for this equivalence study to ensure adequate power to perform a comparison on marginal bone level changes (G*Power 3.1.9, Faul, F., Erdfelder, E., Lang, A.-G., & Bychnner, A, Germany). This analysis indicated that 25 individuals in each group (total study population equal to 50) would be needed to achieve a power of 0.8 with a probability of 0.05 for type 1 (alpha) errors, assuming a standard deviation of 0.89mm, a true difference of zero and a zone of clinical equivalence of ± 0.74mm (Galindo-Moreno, et al. 2014).
Inter-group comparisons for continuous variables (DIB, PPD, DIM) were performed using an independent t-test after being assessed for normality. Homogeneity of variance was assessed using the Levene’s test. A paired t-test was used for intra-group time comparisons. Comparisons using count data (BOP and PI) were assessed using a GEE with a Poisson regression model. Proportions were analyzed using a Chi square or Fisher’s Exact test. A multi-variable linear regression model was used to assess the impact of treatment group, initial implant position (depth), residual ridge height, periodontal status, age and gender on ABL1 and ABL2. The null hypothesis was taken as non-equivalence in marginal alveolar bone loss, proportions of complications, and peri-implant parameters around dental implants placed into augmented maxillary sinuses using ABBM (Bio-Oss®) + AB or blocks of ABBM-C (Bio-Oss Collagen®) alone. A P value of less than or equal to 0.05 was considered to represent statistically significant differences.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 302274 0
Self funded/Unfunded
Name [1] 302274 0
Jamil Alayan
Address [1] 302274 0
Brisbane City Periodontics and Implants
level 11
141 queen street
brisbane QLD 4000
Country [1] 302274 0
Australia
Primary sponsor type
Individual
Name
jamil alayan
Address
Brisbane City Periodontics and Implants
level 11
141 queen street
brisbane QLD 4000
Country
Australia
Secondary sponsor category [1] 302147 0
Individual
Name [1] 302147 0
Saso Ivanovski
Address [1] 302147 0
Brisbane City Periodontics and Implants
level 11
141 queen street
brisbane QLD 4000
Country [1] 302147 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302951 0
The University of Queensland School of Dentistry Dental Sciences Research Ethics Committee
Ethics committee address [1] 302951 0
Turbot Street
Brisbane QLD 4000
Ethics committee country [1] 302951 0
Australia
Date submitted for ethics approval [1] 302951 0
Approval date [1] 302951 0
31/07/2010
Ethics approval number [1] 302951 0
Project Number: 1010

Summary
Brief summary
The aim of this controlled clinical trial was to test whether implant supported restorations have similar biological and technical outcomes when placed into previously augmented maxillary sinuses via the lateral wall approach using stabilized anorganic bovine bone mineral, as used in defined clinical scenarios (i.e. reduced local autogenous bone availability and/or sinus membrane perforation), when compared to those placed into a composite graft of anorganic bovine bone mineral and autogenous bone.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 91954 0
Dr Jamil Alayan
Address 91954 0
Brisbane City Periodontics and Implants
level 11
141 queen street
brisbane 4000
QLD
Country 91954 0
Australia
Phone 91954 0
+61 413121507
Fax 91954 0
Email 91954 0
jamil@bcpi.com.au
Contact person for public queries
Name 91955 0
Dr Jamil Alayan
Address 91955 0
Brisbane City Periodontics and Implants
level 11
141 queen street
brisbane 4000
QLD
Country 91955 0
Australia
Phone 91955 0
+61 413121507
Fax 91955 0
Email 91955 0
jamil@bcpi.com.au
Contact person for scientific queries
Name 91956 0
Dr Jamil Alayan
Address 91956 0
Brisbane City Periodontics and Implants
level 11
141 queen street
brisbane 4000
QLD
Country 91956 0
Australia
Phone 91956 0
+61 413121507
Fax 91956 0
Email 91956 0
jamil@bcpi.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
not relevant to the public assessment of the outcomes.
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – plain English summary
A survival rate of 100% was reported. No significant inter-group differences were noted for all parameters. Radiographic assessment at baseline revealed mean (SD) marginal bone loss of 0.66mm (0.40) and 0.77mm (0.48) from the implant shoulder in the control and test group respectively. After 12 months of loading a mean (SD) additional marginal bone loss of 0.32mm (0.24) and 0.35mm (0.23) was noted in the control and test group respectively. Mucositis (=1 site BOP) was diagnosed in 62.9% of control & 69.23% of test patients. Peri-implantitis was not diagnosed in any patient. Screw retention and single crowns predominated. Technical complications mostly comprised of ceramic veneer chipping and was noted in 7.4% of control and 11.54% of test patients.