- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01641198
An Implant With an Acid-etched Fixture Surface and Internal-hex Collar May Achieve Greater Osseointegration.
Prospective Randomized Clinical Trial Comparing Quantitative Osseous Healing of Acid Etched and Machined Titanium Implant Fixtures After 12 and 24 Months, and at 15-20 Years of Function With Full Arch Fixed Mandibular Prostheses.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This prospective randomized long-term superiority clinical trial tests the hypothesis that an implant with an acid-etched fixture surface and internal-hex machined flat collar results in greater bone preservation.
Age-eligible participants were recruited into this study between 1990 and 1992 from the external clinics of a university dental faculty and hospital affiliated dental department. Study was peer reviewed, had satisfied ethics committee's criteria for human clinical research, and was to take place at the university dental faculty and hospital affiliated department. Sixty participants were enrolled. The study's coordinator evaluated clinical charts to confirm that participants had satisfied the pre-determined inclusion criteria, and that registry operations, data collection, documentation and analysis followed established protocol.
A statistician who was not part of the research team prepared a sampling design that included three Configurations. Each Configuration contained five implants of the three types, thereby allowing an equal number of each implant type to be placed in a cyclical side-by-side rotating fashion at each of five sites between the mental foramen. Consequently, 100 implants of each of the three types were to be placed for a total of 300. However, two participants opted out before start of study so that 58 (30 women) received 290 implants, and each participant acted as their own control. A different identification number was placed on each participant's chart, and allocation concealment then allowed 20 participants to receive Configuration 1, 19 Configuration 2, and 19 Configuration 3. Configuration diagram (but not number) identifying the implant type and length to be placed at each site was stored inside each chart, and only shown to the operating team at surgery. Following restoration with a fixed complete dental prosthesis on the implants, each participant was examined and standardized peri-apical radiographs were taken of each implant after 12 and 24 months and at 15-20 years of function. Distance between first bone-to-implant contact point (fBIC) and crestal abutment-implant interface/microgap (MG) was measured at right and left sides of each abutment-implant surface on the radiographs by examiners who were not part of the research team. Mean fBIC-MG values were then calculated, documented and compared between Brånemark, Swede-Vent and Screw-vent at the three intervals.
Assessment was based on intention to treat. Inter and intra-examiner reliability of measurements was assessed using Intraclass Correlation Coefficient and Bland-Altman Repeatability. Statistical analysis was based on the mixed linear model that included fixed effects of time, implant position, implant configuration, implant type (and implant length as a covariate effect). Position and time were repeated within participants, and Shapiro-Wilk Test was applied to verify that data was following normal distribution. Bonferroni correction was used for pairwise comparisons, and a p value of <0.05 was considered significant. Confidence Interval was established at 2-sided 95% Confidence Level. All statistical analyses were performed using Statistical Package for the Social Sciences (SPSS) Version 23® (IBM Corp, Armonk US).
The following were consulted in order to utilize standardized descriptive terms.
American Society of Anesthesiologists Physical Status Classification System (1963) was used to classify each participant's physical health as Class 1 (obligatory).
Lekholm-Zarb Classification System (1987) was used to classify each participant's quality (density) of mandibular bone as Types 2 and 3 (obligatory).
Salzman Skeletal Bone Intermaxillary Classification System (1966) was used to classify each participant's profile skeletal relationship between maxilla and mandible as Class 1 (obligatory).
American Psychological Association (APA) Publication Manual (2001, fifth edition, Washington, DC) was used to describe certain participant baseline demographic characteristics.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Quebec
-
Montreal, Quebec, Canada, H3C 3J7
- Université de Montréal
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
No systemic disease (ASA Class 1)
Aged between 25 and 56 years
Non-smoking
No Temporomandibular Joint (TMJ) disorder or other facial pain
Wearing of complete maxillary and mandibular removable prostheses for at least one year
Skeletal Class 1 inter-maxillary relationship
Type 2 and/or Type 3 mandibular bone quality
Possess at least 1 cm of bone height between the superior and inferior cortical tables and at least 6 mm of bucco-lingual bone width between mental foramen
Specifically requesting a fixed full arch dental prosthesis over the implants and a conventional full arch removable maxillary prosthesis
Accepting to sign informed consent documents.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Configuration 1
Device placement: B (Brånemark) at two sites, SW (Swede-Vent) at two sites, SC (Screw-Vent) at one site
|
B placed at sites 2 and 5, SW placed at sites 1 and 4, SC placed at site 3
|
EXPERIMENTAL: Configuration 2
Device placement: B (Brånemark) at one site, SW (Swede-Vent) at two sites, SC (Screw-Vent) at two sites
|
B placed at site 3, SW placed at sites 2 and 5, SC placed at sites 1 and 4
|
EXPERIMENTAL: Configuration 3
Device placement: B (Brånemark) at two sites, SW (Swede-Vent) at one site, SC (Screw-Vent) at two sites
|
B placed at sites 1 and 4, SW placed at site 3, SC placed at sites 2 and 5
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparison of Quantitative Bone Healing
Time Frame: After 12 months of function
|
Distance between first bone-to-implant contact point (fBIC) and microgap (MG) placed at the crest was measured at the right and left sides of each implant-abutment complex on periapical radiographs taken of each implant.
Measurements were taken and recorded after 12 months of function.
Mean fBIC-MG values were calculated, recorded and compared between B and SW, between B and SC and between SW and SC for Configuration 1, Configuration 2 and Configuration 3
|
After 12 months of function
|
Comparison of Quantitative Bone Healing
Time Frame: After 24 months of function
|
Distance between first bone-to-implant contact point (fBIC) and microgap (MG) placed at the crest is measured at the right and left sides of each implant-abutment complex on periapical radiographs taken of each implant.
Measurements were taken and recorded after 24 months of function.
Mean fBIC-MG values were calculated, recorded and compared between B and SW, between B and SC and between SW and SC for Configuration 1, Configuration 2 and Configuration 3
|
After 24 months of function
|
Comparison of Quantitative Bone Healing
Time Frame: At 15-20 years of function
|
Distance between first bone-to-implant contact point (fBIC) and microgap (MG) placed at the crest is measured at the right and left sides of each implant-abutment complex on periapical radiographs taken of each implant.
Measurements were taken and recorded at 15 to 20 years of function.
Mean fBIC-MG values were calculated, recorded and compared between B and SW, between B and SC and between SW and SC for Configuration 1, Configuration 2 and Configuration 3
|
At 15-20 years of function
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Patrice Milot, DMD,MSD, Université de Montréal
- Principal Investigator: Hugo Ciaburro, DMD, MSc, Université de Montréal
- Principal Investigator: Aldo-Joseph Camarda, DDS, MSc, Université de Montréal
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12-069-CERES-D
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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