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

NCT03862482 | Completed Results FDA Device

• 1 other identifier: CERC-19-015-P
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Jaw, Edentulous

Keywords

Dental Implants, Microtextured Fixture, Machined Collar

Outcome Measures

Primary Outcomes (1)

• 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

  Distance between first bone-to-implant contact point (fBIC) and microgap (MG) at the crest was measured (mm) at mesial and distal sides of each implant/abutment complex on conventional peri-apical radiographs using a standardized equipment and measurement protocol (Camarda, et al., 2018) after 25 years of function. Values fBIC-MG (Mean ± SE) ("-" for bone loss) were calculated, recorded and compared between all B and all SW, between all B and all SC and between all SW and all SC dental implant units in all three Configurations

  After 25 years (24.6 ± 0.19 years, mean ± SE) of function

Secondary Outcomes (5)

• Comparison of Prosthesis, Abutment, and Implant Mobility or Looseness: Absence (0) or Presence (1) of Mobility or Looseness After 25 Years of Function

  After 25 years (24.6 ± 0.19 years, mean ± SE) of function

• Comparison of Soft Tissue Healing: Height (mm) of Keratinized Tissue After 25 Years of Function

  After 25 years (24.6 ± 0.19 years, mean ± SE) of function

• Comparison of Soft Tissue Healing: Probing Depth (mm) After 25 Years of Function

  After 25 years (24.6 ± 0.19 years, mean ± SE) of function

• Comparison of Soft Tissue Healing: Absence (0) or Presence (1) of Plaque and/or Gingival Bleeding After 25 Years of Function

  After 25 years (24.6 ± 0.19 years, mean ± SE) of function

• Comparison of Soft Tissue Healing: Absence (0) or Presence (1) of Purulent Exudate After 25 Years of Function

  After 25 years (24.6 ± 0.19 years, mean ± SE) of function

Other Outcomes (1)

• Comparison of Two Measurement Systems Used to Evaluate Peri-implant Bone Healing After 25 Years of Function

  After 25 years (24.6 ± 0.19 years, mean ± SE) of function

Study Arms (3)

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

ACTIVE COMPARATOR

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

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

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

EXPERIMENTAL

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

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

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

EXPERIMENTAL

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

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

Interventions

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

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

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

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

Eligibility Criteria

• Age: 48 Years - 82 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• refusal to sign informed consent documents

Sponsors & Collaborators

• Université de Montréal: lead

Study Sites (1)

Université de Montréal

Montreal, Quebec, H3C 3J7, Canada

Location

Related Publications (12)

• 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.

  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.

  PMID: 7246093 BACKGROUND

• 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.

  PMID: 3527955 BACKGROUND

• 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.

  PMID: 16104978 BACKGROUND

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

  PMID: 2868172 BACKGROUND

• 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.

  PMID: 6352924 BACKGROUND

• 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.

  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.

  PMID: 1420725 BACKGROUND

• 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.

  PMID: 10803118 BACKGROUND

• 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.

  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.

  PMID: 33314332 RESULT

• 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.

  PMID: 30202836 RESULT

MeSH Terms

Conditions

Jaw, Edentulous

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Study results are applicable to implants placed between mental foramena in edentulous mandibles of patients, and restored with complete prostheses.

Results Point of Contact

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

aj.camarda@umontreal.ca

514-343-7124

Study Officials

• Aldo J Camarda, DDS, MSc

  Université de Montréal

  PRINCIPAL INVESTIGATOR

• Robert Durand, DMD, MSc

  Université de Montréal

  PRINCIPAL INVESTIGATOR

• Marwa Benkarim

  Université de Montréal

  PRINCIPAL INVESTIGATOR

• Pierre Rompré, MSc

  Université de Montréal

  PRINCIPAL INVESTIGATOR

• Geneviève Guertin, DMD, MSc

  Université de Montréal

  PRINCIPAL INVESTIGATOR

• Hugo Ciaburro, DMD, MSc

  Université de Montréal

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: For the initial study, a statistician had prepared a sampling design that included three configuration diagrams. Each diagram identified five implants of the three types, and showed how one of each type was to be placed in a cyclical, side-by-side, rotating fashion at five sites between mental foramena. Allocation concealment by the project coordinator then allowed 20 participants to receive Configuration 1, 19 had Configuration 2, and 19 had Configuration 3. Configuration diagram (but not number) was stored inside each chart, and only shown to the operating team at the time of surgery. The present study is a continuation of this clinical trial, including data collected at the 25-year (24.6 ± 0.19 years, mean ± SE) follow-up. Twenty-two of the original participants (41.5%, age 71.1 ± 1.2 years, 11 women, 110 implants) were enrolled in this study. Eight participants (40 implants) received Configuration 1, 8 (40 implants) had Configuration 2, and 6 (30 implants) had Configuration 3.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Associate Professor

Study Record Dates

• First Submitted: February 20, 2019
• First Posted: March 5, 2019
• Study Start: June 3, 2019
• Primary Completion: August 16, 2019
• Study Completion: December 31, 2019
• Last Updated: June 14, 2021
• Results First Posted: June 14, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)