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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.

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.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12613001034729
Acronym
The ONE ACT Clinical Trial ( ONE ACT refers to One Abutment One Crown at One Time concept in restor
Enrollment
12
Registered
2013-09-17
Start date
2014-01-02
Completion date
2015-12-04
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 / imp

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.

Sponsors

Dr Anand Patel
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
Yes

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.

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026