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
ACTRN12609000076279
Ethics application status
Approved
Date submitted
28/11/2008
Date registered
30/01/2009
Date last updated
4/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Interventions for replacing missing teeth: single oral implants placed into fresh extraction sockets or healed sites (immediate and delayed placement) to support ceramic single crowns in the anterior maxilla
Scientific title
Interventions for replacing missing teeth: single oral implants placed into fresh extraction sockets or healed sites (immediate and delayed placement) to support ceramic single crowns in the anterior maxilla
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Single tooth loss 4044 0
Condition category
Condition code
Oral and Gastrointestinal 4248 4248 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
Immediate loading of single tapered oral implants placed immediately following extraction of maxillary anterior and premolar teeth.
Intervention code [1] 3766 0
Treatment: Devices
Comparator / control treatment
Immediate loading of single tapered oral implants placed in healed sites (4 months postextraction) in the anterior and premolar sites of the maxilla (A historical control group; Hall et al., 2006).
Control group
Historical

Outcomes
Primary outcome [1] 5133 0
To clinically and radiographically evaluate the success rates of immediately loaded single tapered implants placed at two different times (immediate versus delayed) in the anterior maxilla. The success criteria of Zarb and Albrektsson (1998) and prosthodontic success criteria of Walton (1998) will be used
Timepoint [1] 5133 0
At definitive implant crown placement and then annually for up to five years
Secondary outcome [1] 8642 0
implant stability measurement using resonance frequency analysis
Timepoint [1] 8642 0
At implant placement immediately following extraction and then annually for up to five years
Secondary outcome [2] 8999 0
Crestal bone level changes using standardized radiograph
Timepoint [2] 8999 0
At definitive implant crown placement and then annually for up to five years
Secondary outcome [3] 9000 0
Patient satisfaction using standardized questionnaire
Timepoint [3] 9000 0
At definitive implant crown placement and then annually for up to five years

Eligibility
Key inclusion criteria
(1)Require a single tooth extraction for the anterior maxilla (anterior, canine and premolar teeth).
(2)Minimum age of 18 years.
(3)Willing to provide informed consent.
(4)Adequate oral hygiene.
(5)Able to follow instructions and attend follow-up review appointments for 5 years.
(6)Presence of 4 mm bone apical to the socket
(7) Stable socket walls post-extraction with 3 wall dehiscence of less than 4 mm
(8) Adequate bone quality and quantity (type I-III) (Lekholm and Zarb, 1985).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
(1)Localised infection
(2)Heavy occlusion with parafunctional activity
(3)Smokers
(4)Drug and/or alcohol dependences
(5)Immune-compromised
(6)Uncontrolled diabetes
(7)Dehiscence in extraction socket wall greater than 4 mm
(8) Inadequate bone quality (type IV) (Lekholm and Zarb, 1985)

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
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
3/12/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
32
Accrual to date
Final
Recruitment outside Australia
Country [1] 1422 0
New Zealand
State/province [1] 1422 0

Funding & Sponsors
Funding source category [1] 4222 0
Commercial sector/Industry
Name [1] 4222 0
Southern Implants
Country [1] 4222 0
South Africa
Primary sponsor type
Commercial sector/Industry
Name
Southern Implants
Address
1 Albert Road
Irene 0062
Country
South Africa
Secondary sponsor category [1] 3796 0
None
Name [1] 3796 0
Address [1] 3796 0
Country [1] 3796 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6277 0
Lower South Regional Ethics Committee
Ethics committee address [1] 6277 0
229 Moray Place
Ministry of Health
PO Box 5849
Dunedin 9016
Ethics committee country [1] 6277 0
New Zealand
Date submitted for ethics approval [1] 6277 0
Approval date [1] 6277 0
Ethics approval number [1] 6277 0
LRS/07/08/029

Summary
Brief summary
Objectives: to investigate the success rates, marginal bone level, implant stability and patient satisfaction with immediately loaded single oral implants placed in fresh extraction sockets in anterior maxilla.
A total of 32 participants will receive immediately loaded Co-Axis implants (Southern Implants, Irene, South Africa) placed into fresh extraction sockets. The control group is from a previous research project of similar design (Hall et al., 2007) which involved immediate loading of single oral implants placed in healed sites in anterior maxilla
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29179 0
Address 29179 0
Country 29179 0
Phone 29179 0
Fax 29179 0
Email 29179 0
Contact person for public queries
Name 12336 0
Associate Professor Alan GT Payne
Address 12336 0
Oral Implantology Research Group
Sir John Walsh Research Institute
School of Dentistry
University of Otago
PO Box 647
Dunedin 9054
Country 12336 0
New Zealand
Phone 12336 0
+64 3 479 7119
Fax 12336 0
+64 3 479 5079
Email 12336 0
[email protected]
Contact person for scientific queries
Name 3264 0
Associate Professor Alan GT Payne
Address 3264 0
Oral Implantology Research Group
Sir John Walsh Research Institute
School of Dentistry
University of Otago
PO Box 647
Dunedin 9054
Country 3264 0
New Zealand
Phone 3264 0
+64 3 479 7119
Fax 3264 0
+64 3 479 5079
Email 3264 0
[email protected]

No information has been provided regarding IPD availability


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.