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Trial registered on ANZCTR


Registration number
ACTRN12613001034729
Ethics application status
Not yet submitted
Date submitted
11/09/2013
Date registered
17/09/2013
Date last updated
17/09/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Human clinical trial involving dental implants placed in the smile zone of the mouth comparing the aesthetics of the gum tissue around the implants restored with crowns using 2 different approaches.
Scientific title
A prospective split mouth clinical study comparing the bone levels and soft tissue aesthetics of single tooth implants restored using a one abutment one crown at one time concept with implants restored using the traditional multi abutment/ temporary crown to permanent crown concept.
Secondary ID [1] 283225 0
None
Universal Trial Number (UTN)
U1111-1147-9280
Trial acronym
The ONE ACT Clinical Trial ( ONE ACT refers to One Abutment One Crown at One Time concept in restoration of single tooth dental implants )
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Missing teeth in the smile zone of the mouth 290063 0
Condition category
Condition code
Oral and Gastrointestinal 290442 290442 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
Selection of healthy adults missing a tooth on each side of the same jaw confined to the smile window ( 2nd premolar to 2nd premolar ).
Subjects will be treated with identical dental implants placed using same surgical protocol but the restorations will differ . Test implant will undergo the ONE ACT concept.
The One Act concept refers to one abutment one crown at one time concept. This means at the time of implant placement surgery, an acrylic transfer jig will be made by fixing a transfer / impression coping onto the implant and then laying self curing acrylic over the adjacent natural teeth and around the transfer coping locking it in. This bridging/ jig is removed along with the transfer/ impression coping.

The implant is then going to be buried under the gum by closure through sutures which is referred to as the first or two stage surgery approach.

The transfer jig which was fabricated at the time of the surgery before closure is fitted onto a pre-prepared dental cast with a hole drilled out in the location where the implant was placed in the mouth. When this exercise is done a dummy implant is affixed to the transfer coping exactly as the real one was in the mouth and the dummy implant/ analog is set into the dental case with the hole filled with some self curing acrylic glue . Once set , the transfer coping is unscrewed and now we have our working model with an exact location of the implant as in the mouth transferred onto the cast.

While the healing is taking place over 3 months , the laboratory will work with the model and create an abutment and a definitive, anatomically contoured crown all ready to go in at the same time. When 3 months have lapsed after initial surgery , at the time of second stage surgery , the definitive abutment and the definitive crown will all be inserted and finished at one time , thereby adhering to the one abutment one crown at one time concept. The crown will be contoured to match the tooth as nature would have and the soft tissue is expected to heal and mature around the predefined shape of the crown.

With this concept the whole treatment can be finished at the second stage surgery. For the purposes of the study the first two visits will be used up in preliminary assessments and consent including preliminary data collection.

On the third visit the dental implant will be placed and then the fourth visit will involve a review and removal of sutures. The fifth visit at 3 months after first stage surgery, at the second stage surgery, the treatment will be completed.

Dental X rays and Photographs will be recorded at 6 and 12 months as part of assessment and comparison on which intervention resulted in better bone levels and soft tissue aesthetic outcome.
Intervention code [1] 287927 0
Treatment: Surgery
Comparator / control treatment
Control Implant will undergo the traditional approach to restoration of a single tooth implant in the anterior aesthetic zone.
The first two visits will be used up in preliminary assessments and consent including preliminary data collection. On the third visit the dental implant will be placed and then the fourth and fifth will be a review and removal of sutures.
Visit 6 , 3 months after surgery will see the exposure of the implant though a second stage surgery and fixation of an anatomically shaped and customised transmucosal healing abutment. Sutures will be placed if required.
Visit 7, Review and removal of sutures
Visit 8, a month after Visit 6, dental impressions will be taken for the fabrication of a temporary crown in an attempt to further refine the soft tissue shape around the implant.
Visit 9, Placement of temporary abutment/ crown
Visit 10 , used for first round of data collection for the test implant
Visit 11, after 4.5- 5.5 months of having the temporary crown in place, a new impression will be recorded to make a permanent crown to match the shape of the gum.
Visit 12, insertion of permanent crown
Visit 13 , 6 months after permanent crown , for review and data collection.
Visit 14, 12 months after permanent crown, for review and data collection.

visit which requires a temporary crown be made to help shape the gum and then a definitive crown is made to conform to the soft tissue out come from the temporary phase .
Control group
Active

Outcomes
Primary outcome [1] 290466 0
Primary Outcome 1: Bone level changes measured around implants undergoing the ONE ACT concept and those undergoing the Traditional Restorative approach.
Dental Periapical x rays using a standardised paralleling technique will be used to assess bone level changes. These x rays will be enlarged and printed on photopaper. Co-assessors will measure the dimensions required using callipers.
Timepoint [1] 290466 0
Timepoint : at 6 and 12 months after the insertion of permanent crowns on both the Test and Control implants
Primary outcome [2] 290467 0
Primary Outcome : Macro Phtotographs recorded of the Test and Control implants with one whole tooth on both sides of the implant including the soft tissue to assess the PINK ESTHETIC SCORE at defined by Furhauser et al ( 2005)
Timepoint [2] 290467 0
Primary Timepoint: At 6 and 12 months after insertion of the permanent definitive crowns.
Secondary outcome [1] 304563 0
PINK ESTHETIC SCORE of both the TEST and CONTROL Implants/crowns compared with a natural tooth ( identical FDI tooth number if possible ) on the contralateral side
Timepoint [1] 304563 0
Time Point : At 6 and 12 month after insertion of the permanent definitive crowns.

Eligibility
Key inclusion criteria
Inclusion criteria
Healthy males and females over the age of 18 will:
*Be informed of the nature of the study and will be given a written informed consent,
*Have no significant diseases/ medical conditions during screening,
*Be on no regular medical treatment or on medication affecting bone physiology,
*Be able to communicate effectively with study personnel,
&Have a missing tooth on each side of the one jaw in the antero lateral segments,
*Have adequate bone levels (judged by radiographic assessment) to afford an implant based therapy to replace these missing teeth, and
*Be keen and motivated to have these missing teeth replaced.
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria
*Any disease or condition which might compromise the haematopoietic, renal, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system.
*History of allergic conditions – asthma, urticaria, eczema.
*History of autoimmune disorders – lupus erythematosis (SLE).
*History of psychiatric disorders.
*Smokers
*Pregnancy or not using appropriate means on contraception.
*Use of any recreational drugs or a history of drug addiction.
*Bisphosphonate therapy.
*Patients with uncontrolled dental diseases like caries and periodontitis.
*Poor Oral hygiene
*Ridge deficiencies that warrant bone augmentation procedure either at or prior to implant placement. The minimum ridge dimension of 7mm width as measured by a ridge caliper or using a cone beam CT scan will be applied as a preliminary criteria. ( Should the subject need an augmentation for implants to be placed and should he/ she meet no other exclusion criteria but meet all inclusion criteria , he/ she can be reassessed for inclusion 6 months after an augmentation procedure ( at patients cost ) ).
*Patients lack of availability as and when recalled or attitudes / expectations gauged during interview process will be assessed for eligibility for the study.

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)
Interested participants will undergo initial health and oral examination followed by radiographic assessment if upon initial assessment they appear to qualify for the study. If after radiographic assessment the subject is deemed fit for the study, he/ she will be presented with the appropriate consent forms. Upon consent , the subjects will be assigned randomised identification numbers which will be recorded on all data collected.

The allocation concealment will be done through the use of sealed opaque envelopes.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The determination of test and control sites will be made using either a randomization software or a permuted block randomization process to be confirmed by the biostatistician .
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
In this study, we are using split-mouth design. The advantage is the need for smaller sample size as compared to normal design as the much of inter-subject variability is removed because each patient acts as his/her own control(left side as compared to left side of Jaw). This results in increased study power or a decrease in the number of participants required compared with a study in which patients receive only one intervention. Sample size depends also on the similarity of the sites within patients and it is estimated that the sample size may be further reduced compared with a parallel trial as the within-participant correlation increases. As the coefficient of correlation gets closer to one, the required sample size may be dramatically reduced. As our method is a new approach, there is no available data of mean and SD for the sample size calculation. Therefore we are using this number based on the literature in which there are mostly 12-15 patients needed to participate in the trials that use split-month design.

Recruitment
Recruitment status
Not yet 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)
NT

Funding & Sponsors
Funding source category [1] 287945 0
Other
Name [1] 287945 0
Co-Sponsor : Extreme Dentistry ( Private Dental surgery )
Address [1] 287945 0
12 Orchard Road ,
Coconut Grove ,
Darwin,
Northern Territory 0810
Country [1] 287945 0
Australia
Funding source category [2] 287946 0
Other
Name [2] 287946 0
Subjects Participating in Trial will be required to meet the cost of implant components and prosthetic lab fees
Address [2] 287946 0
12 Orchard Road
Coconut Grove,
Darwin,
NT, 0810
Country [2] 287946 0
Australia
Primary sponsor type
Individual
Name
Dr Anand Patel
Address
Extreme Dentistry,
12 Orchard Road
Coconut Grove,
Darwin,
NT 0810
Country
Australia
Secondary sponsor category [1] 286664 0
None
Name [1] 286664 0
Address [1] 286664 0
Country [1] 286664 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 289873 0
Human Research Ethics Committee (HREC) of the Northern Territory Department of Health and Menzies School of Health Reasearch
Ethics committee address [1] 289873 0
P O Box 41096
Casuarina,
NT, 0811.
Ethics committee country [1] 289873 0
Australia
Date submitted for ethics approval [1] 289873 0
06/11/2013
Approval date [1] 289873 0
Ethics approval number [1] 289873 0

Summary
Brief summary
The evaluation of the soft tissue level outcome of implants placed and restored in the anterior –premolar regions using a “one abutment one crown at one time concept “ compared to the traditional protocol of multiple abutments and crowns (temporary and permanent). The soft tissue parameters will be evaluated using the papilla score, pink esthetic score, plaque and bleeding on probing upto 1 year after the placement of the definitive/ permanent restoration.
Research hypothesis
The soft tissue formation and stabilization around single dental implants in the esthetic zone is achieved in a faster and more predictable way when the “one abutment, one crown at one time“ protocol is used.

Trial website
Trial related presentations / publications
Public notes
Scheduled clinic visits

Visit number, Week / Time line and type of visit /procedure-

Visit 1:Week 1; Interview/ Initial oral assessment

Visit 2: Week2; Radiographic assessment/ consent / preliminary Records

Visit 3: Week 4;Implant placement surgery

Visit 4: Week 5;One week review after surgery

Visit 5: Week 6;Two Week Review and removal of sutures

Visit 6: Week 16; Second Stage surgery, 12 weeks after surgery and restoration of test implant

Visit 7: Week 17;Review and removal of sutures

Visit 8: Week20; Impressions for a temporary crown for the control implant

Visit 9: Week 24,Placement of the temporary abutment/ crown on control Implant

Visit 10: Week 30;1st Round data collection for test implant

Visit 11: Week 42;Impressions for permanent crown on control implant, 2nd data collection for test implant

Visit 12: Week 48; Permanent restoration of control implant

Visit 13:Week 68; 2nd Data collection on test implant and 1st Data collection on control Implant

Visit 14:Week 100;2nd Data collection on control implant

Contacts
Principal investigator
Name 42874 0
Dr Anand Patel
Address 42874 0
Extreme Dentistry,
12 Orchard Road,
Coconut Grove,
Darwin,
NT 0810
Country 42874 0
Australia
Phone 42874 0
+618-89481225
Fax 42874 0
+618-89485233
Email 42874 0
anand.patel@bigpond.com
Contact person for public queries
Name 42875 0
Dr Anand Patel
Address 42875 0
Extreme Dentistry,
12 Orchard Road,
Coconut Grove,
Darwin,
NT 0810
Country 42875 0
Australia
Phone 42875 0
+618-89481225
Fax 42875 0
+618-89485233
Email 42875 0
anand.patel@bigpond.com
Contact person for scientific queries
Name 42876 0
Dr Anand Patel
Address 42876 0
Extreme Dentistry,
12 Orchard Road,
Coconut Grove,
Darwin,
NT 0810
Country 42876 0
Australia
Phone 42876 0
+618-89481225
Fax 42876 0
+618-89485233
Email 42876 0
anand.patel@bigpond.com

No data has been provided for results reporting
Summary results
Not applicable