An Implant With an Acid-etched Fixture Surface and Internal-hex Collar May Achieve Greater Osseointegration.

NCT01641198 | Completed Results DMC FDA Device

• 1 other identifier: 12-069-CERES-D
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

Brånemark System® dental implant osseointegration was introduced clinically in 1965 as a novel approach to the replacement of missing teeth. Although this implant's traditional machined screw-shaped surface had excellent, well-documented short- and long-term osseointegration success, newer implant designs were introduced that could enhance biological fusion of the implant to jaw bones, allowing more rapid restoration and function. It was also claimed that such implants could lead to less bone loss with function. One such implant, Screw-Vent®, had a macrostructure very similar to that of the Brånemark implant, except that it's fixture surface was acid-etched which could enhance biological osseointegration. It also had a longer narrower smooth internal-hex interlocking flat collar that could better resist occlusal forces, leading to even less bone loss according to the manufacturer. However, no well-controlled clinical studies existed in 1990 that supported these claims. This study was undertaken, therefore, to first compare the Brånemark implant with another implant, Swede-Vent®, a copy of the Brånemark implant except for its fixture surface that was identically acid-etched as that of Screw-Vent by the same manufacturer. The effect on bone healing could then be compared between Brånemark's machined and Swede-Vent's acid-etched surfaces in the short- and long-terms. Our hypothesis was that the microtextured Swede-Vent fixture would lead to greater bone preservation. Since Screw-Vent's fixture surface was identically acid-etched as that of Swede-Vent by the same manufacturer, we could then evaluate the effect on bone healing of Screw-Vent's collar and the shorter wider machined smooth external-hex flat collar of Swede-Vent (identical to that of Brånemark). All three 2-part platform-matched parallel-wall implants were made of commercially pure titanium, had a very similar fixture macro-design, were approved by the Food and Drug Administration (USA) and Health and Welfare Canada, and were commercially available in North America. Brånemark is still available, but with an oxidized microtextured fixture surface and a shortened machined smooth external-hex flat collar. Screw-Vent is still available with its microtextured fixture surface, but its machined smooth internal-hex flat collar has also been substantially shortened. Swede-Vent is no longer available.

Conditions

Jaw, Edentulous; Dental Implant

Keywords

Dental Implants Microtextured Fixture Machined Collar Bone

Outcome Measures

Primary Outcomes (3)

• Comparison of Quantitative Bone Healing

  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

  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

  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

Study Arms (3)

Configuration 1

ACTIVE COMPARATOR

Device placement: B (Brånemark) at two sites, SW (Swede-Vent) at two sites, SC (Screw-Vent) at one site

Device: Configuration 1

Configuration 2

EXPERIMENTAL

Device placement: B (Brånemark) at one site, SW (Swede-Vent) at two sites, SC (Screw-Vent) at two sites

Device: Configuration 2

Configuration 3

EXPERIMENTAL

Device placement: B (Brånemark) at two sites, SW (Swede-Vent) at one site, SC (Screw-Vent) at two sites

Device: Configuration 3

Interventions

Configuration 1 DEVICE

B placed at sites 2 and 5, SW placed at sites 1 and 4, SC placed at site 3

Configuration 1

Configuration 2 DEVICE

B placed at site 3, SW placed at sites 2 and 5, SC placed at sites 1 and 4

Configuration 2

Configuration 3 DEVICE

B placed at sites 1 and 4, SW placed at site 3, SC placed at sites 2 and 5

Configuration 3

Eligibility Criteria

• Age: 25 Years - 56 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Université de Montréal: lead
• Medical Research Council of Canada, FRSQ, CoreVent, Université de Montréal: collaborator

Study Sites (1)

Université de Montréal

Montreal, Quebec, H3C 3J7, Canada

Location

MeSH Terms

Conditions

Jaw, Edentulous

Condition Hierarchy (Ancestors)

Jaw Diseases; Musculoskeletal Diseases; Stomatognathic Diseases; Mouth, Edentulous; Mouth Diseases; Tooth Diseases

Results Point of Contact

• Title: Dr. Aldo-Joseph Camarda
• Organization: Université de Montréal

aj.camarda@umontreal.ca

(514) 343-7124

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 6, 2012
• First Posted: July 16, 2012
• Study Start: March 1, 1992
• Primary Completion: March 24, 1998
• Study Completion: September 30, 2013
• Last Updated: December 17, 2020
• Results First Posted: January 16, 2019

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)