Clinical trial NCT03862482: Peri-Implant Healing Around Two Different Machined-Collar Designs After 25 Years of Function
Official title: Prospective Randomised Clinical Trial Evaluating the Effects of Two Different Implant Collar Designs on Peri-Implant Healing and Functional Osseointegration After 25 Years of Function With Full Arch Mandibular Prostheses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Jaw, Edentulous
Keywords: Dental Implants, Microtextured Fixture, Machined Collar
Lead sponsor: Université de Montréal
Sponsor class: OTHER
First posted: 2019-03-05
Enrollment: 22
Sex: ALL
Minimum age (years): 48
Maximum age (years): 82
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Comparison of Distance Between First Bone to Implant Contact Point (fBIC) and Microgap (MG), After 25 Years of Function, Between All B, All SW, and All SC Dental Implant Units in All Three Configurations
timeFrame: After 25 years (24.6 ± 0.19 years, mean ± SE) of function
Secondary outcomes:
measure: Comparison of Prosthesis, Abutment, and Implant Mobility or Looseness: Absence (0) or Presence (1) of Mobility or Looseness After 25 Years of Function
timeFrame: After 25 years (24.6 ± 0.19 years, mean ± SE) of function
measure: Comparison of Soft Tissue Healing: Height (mm) of Keratinized Tissue After 25 Years of Function
timeFrame: After 25 years (24.6 ± 0.19 years, mean ± SE) of function
measure: Comparison of Soft Tissue Healing: Probing Depth (mm) After 25 Years of Function
timeFrame: After 25 years (24.6 ± 0.19 years, mean ± SE) of function
measure: Comparison of Soft Tissue Healing: Absence (0) or Presence (1) of Plaque and/or Gingival Bleeding After 25 Years of Function
timeFrame: After 25 years (24.6 ± 0.19 years, mean ± SE) of function
measure: Comparison of Soft Tissue Healing: Absence (0) or Presence (1) of Purulent Exudate After 25 Years of Function
timeFrame: After 25 years (24.6 ± 0.19 years, mean ± SE) of function
Other outcomes:
measure: Comparison of Two Measurement Systems Used to Evaluate Peri-implant Bone Healing After 25 Years of Function
timeFrame: After 25 years (24.6 ± 0.19 years, mean ± SE) of function
Locations:
city: Montreal
country: Canada
facility: Université de Montréal
state: Quebec
Study officials:
affiliation: Université de Montréal
name: Aldo J Camarda, DDS, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Université de Montréal
name: Robert Durand, DMD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Université de Montréal
name: Marwa Benkarim
role: PRINCIPAL_INVESTIGATOR
affiliation: Université de Montréal
name: Pierre Rompré, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Université de Montréal
name: Geneviève Guertin, DMD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Université de Montréal
name: Hugo Ciaburro, DMD, MSc
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet. 1986 Feb 8;1(8476):307-10.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.