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Trial registered on ANZCTR
Registration number
ACTRN12608000569303
Ethics application status
Approved
Date submitted
10/10/2008
Date registered
12/11/2008
Date last updated
4/07/2012
Type of registration
Prospectively registered
Titles & IDs
Public title
Single implant crowns placed immediately after molar tooth removal
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Scientific title
Interventions for replacing missing teeth: single oral implants placed into fresh extraction sockets or early or completely healed sockets (immediate, early and delayed placement) to support single implant crowns for 5 years
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Secondary ID [1]
262475
0
there isn't a secondary ID for this trial
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Universal Trial Number (UTN)
There is no UTN
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Single tooth loss
3817
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Condition category
Condition code
Oral and Gastrointestinal
3999
3999
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0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Placement of single endosseous wide diameter titanium oral implants in the fresh extraction sockets or early healed sockets (3-5 weeks) in the molar region to support single implant crowns for 5 years.
Surgical technique: Atraumatic extraction, sectioning of the molars and removal of each root individually. Sockets will be prepared with standard drills and tapered osteotomes to prepare the interradicular bone.
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Intervention code [1]
3536
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Treatment: Devices
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Comparator / control treatment
Placement of single endosseous wide diameter titanium oral implants after complete bone healing (at least 4 months post-extraction) in the molar region.
Same type of implants will be used in both test and control groups.
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Control group
Active
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Outcomes
Primary outcome [1]
4903
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To evaluate the success rates of single wide-diameter implants placed at different times following extraction of molar teeth.
The success criteria of Zarb and Albrektsson (1998) and prosthodontic success criteria of Walton (1998) will be used.
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Assessment method [1]
4903
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Timepoint [1]
4903
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After implant placement and then annually for up to 5 years
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Secondary outcome [1]
8279
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To evaluate the crestal bone level using standardised radiographs (Payne et al 1999) and peri-implant microbiota through collecting plaque samples for detection and quantification of microbial pathogens by real-time polymerase chain reaction (PCR)
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Assessment method [1]
8279
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Timepoint [1]
8279
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After implant placement and then annually for up to 5 years
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Eligibility
Key inclusion criteria
(1) Require a single molar tooth extraction in either jaw. (2) Aged 18 or over. (3) Physical status P1 or P2, according to the classification system of the American Society of Anesthesiologists (ASA) (4) Controlled oral hygiene. (5) Type I-III bone quality (Lekholm and Zarb, 1985). (6) Presence of 3-4 remaining osseous walls. (7) Good compliance and commitment to attend follow-up review appointments. (8) Willing to provide informed consent.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
(1) Traumatic tooth extraction. (2) Dehiscence in extraction socket wall greater than 4 mm. (3) Inadequate bone quality (Type IV) (Lekholm and Zarb, 1985). (4) Localized infection (suppuration at the surgical field) (5) Ankylosed teeth. (6) Aggressive or refractory periodontitis. (7)Severe bruxism or parafunctional habits. (8) Large occlusal discrepancies. (9) Medical risk patients.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not applicable
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Date of first participant enrolment
Anticipated
12/11/2008
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
39
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
1259
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New Zealand
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State/province [1]
1259
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Funding & Sponsors
Funding source category [1]
3998
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Commercial sector/Industry
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Name [1]
3998
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Southern Implants
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Address [1]
3998
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1 Albert Road
Irene 0062
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Country [1]
3998
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South Africa
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Primary sponsor type
Commercial sector/Industry
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Name
Southern Implants
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Address
1 Albert Road
Irene 0062
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Country
South Africa
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Secondary sponsor category [1]
3655
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None
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Name [1]
3655
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Address [1]
3655
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Country [1]
3655
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
6075
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Lower South Regional Ethics Committee
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Ethics committee address [1]
6075
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229 Moray Place
Ministry of Health
PO Box 5849
Dunedin
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Ethics committee country [1]
6075
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New Zealand
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Date submitted for ethics approval [1]
6075
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Approval date [1]
6075
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Ethics approval number [1]
6075
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LRS/08/08/034
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Summary
Brief summary
Objectives: To evaluate the clinical outcomes, peri-implant parameters, microbial environment and success rates of three different placement times of single wide implants for replacing molar teeth.
Materials and mehtods:
Wide –diameter implants will be placed at different times following extraction of a single molar tooth in either mandibular or maxillary arches. A total of 39 participants will be randomly allocated to three equal sized groups (13 per group), a control and one of the test groups as follows:
Control group: Implants placed after complete bone healing
Test group 1: Implants immediately place after extraction
Test group II: Implants placed after an early osseous healing time (3-5 weeks).
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
29027
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Address
29027
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Country
29027
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Phone
29027
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Fax
29027
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Email
29027
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Contact person for public queries
Name
12184
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Dr Warwick Duncan
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Address
12184
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Oral Implantology Research Group
Sir John Walsh Research Institute
School of Dentistry
University of Otago
P.O Box 647
Dunedin 9054
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Country
12184
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New Zealand
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Phone
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+64 3 479 7110
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Fax
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+64 3 479 5079
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Email
12184
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[email protected]
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Contact person for scientific queries
Name
3112
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Dr Warwick Duncan
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Address
3112
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Oral Implantology Research Group
Sir John Walsh Research Institute
School of Dentistry
University of Otago
P.O Box 647
Dunedin 9054
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Country
3112
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New Zealand
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Phone
3112
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+64 3 479 7110
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Fax
3112
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+64 3 479 5079
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Email
3112
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[email protected]
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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.
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