Peri-Implant Healing Around Two Different Machined-Collar Designs After 25 Years of Function

NCT ID: NCT03862482

Last Updated: 2021-06-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-03
• Study Completion Date: 2019-12-31

Brief Summary

Brånemark System® dental implant osseointegration was introduced in 1965 as a novel approach to the replacement of missing teeth. Although this implant's machined, screw-shaped surface had excellent, well-documented, short- and long-term clinical success (Adell, R. 1987; Albrektsson, T., et al., 1981; Albrektsson, T., et al., 1986; Brånemark, P-I. , 1983; Brånemark P-I. 1987), newer implant designs were introduced that could enhance fusion of the implant to jaw bones, and better resist functional forces. One such implant, Screw-Vent®, has a fixture macro structure very similar to that of the Brånemark® implant. However, its fixture surface was acid etched (1-3µm) which could enhance osseointegration, and it has a longer, narrower machined internal-hex, friction-fit collar that could better resist functional forces.These characteristics should lead to less bone loss (Niznick, G. A., 1989). However, one clinical study (De Bruyen, et al., 1992) reported greater short-term bone loss with this implant compared to the Brånemark® implant, possibly due to its longer machined collar, and advocated long-term clinical studies. Therefore, this prospective within-subject clinical trial was undertaken in 1993 to first compare the Brånemark® implant with another implant, Swede-Vent®, a copy of the Brånemark® macro structure except for its fixture surface that was identically micro textured 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 micro textured fixture surfaces in the short- and long-terms. Since Screw-Vent®'s fixture surface was identically micro textured as that of Swede-Vent®, the investigators could then evaluate and compare the effects on bone healing of Screw-Vent®'s longer, narrower, internal-connection machined collar to the identical shorter, wider, external-connection machined collars of the Swede-Vent® and Brånemark® implants. All three two-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® and Screw-Vent® implants are still available, but the Swede-Vent® implant is not.

Detailed Description

Therefore, between 1993 and 1996, 58 of 60 eligible participants had been recruited into a prospective, randomized clinical trial. This trial had been peer reviewed, had received ethical approval, and had taken place at the Université de Montréal's Faculty of Dental Medicine and its affiliated hospital dental department. Follow-up documentation occurred at one year, two years, and 15 to 20 years following prostheses attachment (ClinicalTrials Identification Number NCT01641198), and the results were published (Camarda, et al., 2018). The present study reports on data collected at the 25-year (24.6 ± 0.19 years, mean ± SE) follow-up (ClinicalTrials Identification Number NCT03862482), focusing specifically on the evaluation and comparison of the effects on peri-implant healing and functional osseointegration of the two different machined collar designs. That is to say, the identical shorter, wider, external-connection Brånemark® and Swede-Vent® collars versus the longer, narrower, internal-connection Screw-Vent® collar. Twenty-two of the original participants (41.5%, age 71.1 ± 1.2 years, 11 women, 110 implants) were enrolled into this study. All study procedures were performed in accordance with the Helsinki Declaration and its later amendments, and all participants signed informed consent documents prior to inclusion into this study.

Conditions

Jaw, Edentulous

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Brånemark® 2, Swede-Vent® 2, Screw-Vent® 1 (Configuration 1)

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

Group Type: ACTIVE_COMPARATOR

Brånemark® 2, Swede-Vent® 2, Screw-Vent® 1 (Configuration 1)

Intervention Type: DEVICE

Brånemark® implant placed at sites 2 (left medial) and 5 (right distal), Swede-Vent® implant placed at sites 1 (left distal) and 4 (right medial), Screw-Vent® implant placed at site 3 (para symphysis)

Brånemark® 1, Swede-Vent® 2, Screw-Vent® 2 (Configuration 2)

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

Group Type: EXPERIMENTAL

Brånemark® 1, Swede-Vent® 2, Screw-Vent® 2 (Configuration 2)

Intervention Type: DEVICE

Brånemark® implant placed at site 3 (para symphysis), Swede-Vent® implant placed at sites 2 (left medial) and 5 (right distal), Screw-Vent® implant placed at sites 1 (left distal) and 4 (right medial)

Brånemark® 2, Swede-Vent® 1, Screw-Vent® 2 (Configuration 3)

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

Group Type: EXPERIMENTAL

Brånemark® 2, Swede-Vent® 1, Screw-Vent® 2 (Configuration 3)

Intervention Type: DEVICE

Brånemark® implant placed at sites 1 (left distal) and 4 (right medial), Swede-Vent® implant placed at site 3 (para symphysis), Screw-Vent® implant placed at sites 2 (left medial) and 5 (right distal)

Interventions

Brånemark® 2, Swede-Vent® 2, Screw-Vent® 1 (Configuration 1)

Brånemark® implant placed at sites 2 (left medial) and 5 (right distal), Swede-Vent® implant placed at sites 1 (left distal) and 4 (right medial), Screw-Vent® implant placed at site 3 (para symphysis)

Intervention Type: DEVICE

Brånemark® 1, Swede-Vent® 2, Screw-Vent® 2 (Configuration 2)

Brånemark® implant placed at site 3 (para symphysis), Swede-Vent® implant placed at sites 2 (left medial) and 5 (right distal), Screw-Vent® implant placed at sites 1 (left distal) and 4 (right medial)

Intervention Type: DEVICE

Brånemark® 2, Swede-Vent® 1, Screw-Vent® 2 (Configuration 3)

Brånemark® implant placed at sites 1 (left distal) and 4 (right medial), Swede-Vent® implant placed at site 3 (para symphysis), Screw-Vent® implant placed at sites 2 (left medial) and 5 (right distal)

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• non-smoker
• no temporomandibular joint (TMJ) disorder or facial pain
• having participated in the original study (1993 - 1996) at which time the minimum participants' age was 25 years and the maximum 56 years

Exclusion Criteria

• refusal to sign informed consent documents

• Minimum Eligible Age: 48 Years
• Maximum Eligible Age: 82 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Université de Montréal

OTHER

Sponsor Role: lead

Responsible Party

Aldo Joseph Camarda

Principal Investigator, Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Aldo J Camarda, DDS, MSc

Role: PRINCIPAL_INVESTIGATOR

Université de Montréal

Robert Durand, DMD, MSc

Role: PRINCIPAL_INVESTIGATOR

Université de Montréal

Marwa Benkarim

Role: PRINCIPAL_INVESTIGATOR

Université de Montréal

Pierre Rompré, MSc

Role: PRINCIPAL_INVESTIGATOR

Université de Montréal

Geneviève Guertin, DMD, MSc

Role: PRINCIPAL_INVESTIGATOR

Université de Montréal

Hugo Ciaburro, DMD, MSc

Role: STUDY_DIRECTOR

Université de Montréal

Locations

Université de Montréal

Montreal, Quebec, Canada

Countries

Canada

References

Adell, R. (1987). Long-term treatment results. In: Brånemark, P-I., Zarb, G.A., Albrektsson, T. (Eds.). Tissue-integrated prostheses: osseointegration in clinical dentistry (pp. 175-285). Quintessence Publishing Co. Inc.

Reference Type: BACKGROUND

Albrektsson T, Branemark PI, Hansson HA, Lindstrom J. Osseointegrated titanium implants. Requirements for ensuring a long-lasting, direct bone-to-implant anchorage in man. Acta Orthop Scand. 1981;52(2):155-70. doi: 10.3109/17453678108991776.

Reference Type: BACKGROUND

PMID: 7246093 (View on PubMed)

Albrektsson T, Zarb G, Worthington P, Eriksson AR. The long-term efficacy of currently used dental implants: a review and proposed criteria of success. Int J Oral Maxillofac Implants. 1986 Summer;1(1):11-25. No abstract available.

Reference Type: BACKGROUND

PMID: 3527955 (View on PubMed)

Bhaskaran V, Qualtrough AJ, Rushton VE, Worthington HV, Horner K. A laboratory comparison of three imaging systems for image quality and radiation exposure characteristics. Int Endod J. 2005 Sep;38(9):645-52. doi: 10.1111/j.1365-2591.2005.00998.x.

Reference Type: BACKGROUND

PMID: 16104978 (View on PubMed)

Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet. 1986 Feb 8;1(8476):307-10.

Reference Type: BACKGROUND

PMID: 2868172 (View on PubMed)

Branemark PI. Osseointegration and its experimental background. J Prosthet Dent. 1983 Sep;50(3):399-410. doi: 10.1016/s0022-3913(83)80101-2. No abstract available.

Reference Type: BACKGROUND

PMID: 6352924 (View on PubMed)

Brånemark P-I. (1987). Introduction to osseointegration. In Brånemark, P-I., Zarb, G.A., Albrektsson, T. (Eds.). Tissue-integrated prostheses: osseointegration in clinical dentistry (pp. 11-76). Quintessence Publishing Co. Inc.

Reference Type: BACKGROUND

De Bruyn H, Collaert B, Linden U, Flygare L. A comparative study of the clinical efficacy of Screw Vent implants versus Branemark fixtures, installed in a periodontal clinic. Clin Oral Implants Res. 1992 Mar;3(1):32-41. doi: 10.1034/j.1600-0501.1992.030106.x.

Reference Type: BACKGROUND

PMID: 1420725 (View on PubMed)

Galgut P. A comparison of different indices used in the clinical assessment of plaque and gingival bleeding. Clin Oral Investig. 1999 Jun;3(2):96-9. doi: 10.1007/s007840050085.

Reference Type: BACKGROUND

PMID: 10803118 (View on PubMed)

Niznick, G. A. (1989). Open letters no. 1 and no. 2 to the dental profession, Core-Vent Corporation Newsletter and manufacturer's product description. Encino, California USA.

Reference Type: BACKGROUND

Camarda AJ, Durand R, Benkarim M, Rompre PH, Guertin G, Ciaburro H. Prospective randomized clinical trial evaluating the effects of two different implant collar designs on peri-implant healing and functional osseointegration after 25 years. Clin Oral Implants Res. 2021 Mar;32(3):285-296. doi: 10.1111/clr.13699. Epub 2021 Jan 25.

Reference Type: RESULT

PMID: 33314332 (View on PubMed)

Camarda AJ, Milot P, Ciaburro H, Rompre PH, Sallaleh I, Do CMA. Long-term randomized clinical trial evaluating the effects of fixture surface acid-etching and machined collar design on bone healing. Quintessence Int. 2018;49(9):733-743. doi: 10.3290/j.qi.a41013.

Reference Type: RESULT

PMID: 30202836 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CERC-19-015-P

Identifier Type: -

Identifier Source: org_study_id