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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
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
Secondary ID [1] 262475 0
there isn't a secondary ID for this trial
Universal Trial Number (UTN)
There is no UTN
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Single tooth loss 3817 0
Condition category
Condition code
Oral and Gastrointestinal 3999 3999 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
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.
Intervention code [1] 3536 0
Treatment: Devices
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.
Control group
Active

Outcomes
Primary outcome [1] 4903 0
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.
Timepoint [1] 4903 0
After implant placement and then annually for up to 5 years
Secondary outcome [1] 8279 0
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)
Timepoint [1] 8279 0
After implant placement and then annually for up to 5 years

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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
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.

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)
Not applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

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 outside Australia
Country [1] 1259 0
New Zealand
State/province [1] 1259 0

Funding & Sponsors
Funding source category [1] 3998 0
Commercial sector/Industry
Name [1] 3998 0
Southern Implants
Address [1] 3998 0
1 Albert Road
Irene 0062
Country [1] 3998 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] 3655 0
None
Name [1] 3655 0
Address [1] 3655 0
Country [1] 3655 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6075 0
Lower South Regional Ethics Committee
Ethics committee address [1] 6075 0
229 Moray Place
Ministry of Health
PO Box 5849
Dunedin
Ethics committee country [1] 6075 0
New Zealand
Date submitted for ethics approval [1] 6075 0
Approval date [1] 6075 0
Ethics approval number [1] 6075 0
LRS/08/08/034

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).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29027 0
Address 29027 0
Country 29027 0
Phone 29027 0
Fax 29027 0
Email 29027 0
Contact person for public queries
Name 12184 0
Dr Warwick Duncan
Address 12184 0
Oral Implantology Research Group
Sir John Walsh Research Institute
School of Dentistry
University of Otago
P.O Box 647
Dunedin 9054
Country 12184 0
New Zealand
Phone 12184 0
+64 3 479 7110
Fax 12184 0
+64 3 479 5079
Email 12184 0
warwick.duncan@otago.ac.nz
Contact person for scientific queries
Name 3112 0
Dr Warwick Duncan
Address 3112 0
Oral Implantology Research Group
Sir John Walsh Research Institute
School of Dentistry
University of Otago
P.O Box 647
Dunedin 9054
Country 3112 0
New Zealand
Phone 3112 0
+64 3 479 7110
Fax 3112 0
+64 3 479 5079
Email 3112 0
warwick.duncan@otago.ac.nz

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary