Influence of the Implant-prosthetic Connection in the Marginal Bone Loss and Bacterial Leakage

NCT04328051 | Unknown DMC

• 1 other identifier: UBarcelonaOralSurgery2
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

This study consists in a double-blinded randomized controlled trial which objective is to assess the effect of the implant-abutment connection type -external hexagon, internal hexagon and conical connection- in the periimplant marginal bone loss in vertical side and the bacterial leakage 12 months after prosthesis placement.

Conditions

Dental Implant; Bone Loss; Bacterial Infections

Keywords

Dental Implant; Internal Connection; External Connection; Conical Connection; Marginal Bone Loss; Implant Prosthetic Connection; Bacterial Leakage

Outcome Measures

Primary Outcomes (1)

• Change in Vertical Marginal Bone Loss (VMBL)

  Distance in millimetres between the implant platform and the point of the intra-bone defect that is more apical.

  Since implant placement (Timing 0) through study completion (Timing 5), an average of 1 year.

Secondary Outcomes (12)

• Vertical Marginal Bone Loss Tax

  12 months after prosthesis placement.

• Early implant failure

  Since implant placement (Timing 0) through prosthesis placement (Timing 1).

• Late implant failure

  Since prosthesis placement (Timing 1) through study completion (Timing 5), an average of 1 year.

• Probing pocket depth

  Since prosthesis placement (Timing 1) through study completion (Timing 5), an average of 1 year.

• Mucosal recession

  Since prosthesis placement (Timing 1) through study completion (Timing 5), an average of 1 year.

Study Arms (3)

Ocean E.C.®, Avinent Implant System S.L.

ACTIVE COMPARATOR

Dental implant with geometry adapted to the biologic architecture of the bone, with platform switching with a positive angle and machined surface with micro-threads in the cervical region. Asymmetric and progressive threads in its body with a double thread pitch. Point-ratio geometry on its apical region, Biomimetic Advanced Surface and external hexagon connection.

Other: Dental Implant Placement

Ocean I.C.®, Avinent Implant System S.L.

ACTIVE COMPARATOR

Dental implant with geometry adapted to the biologic architecture of the bone, with platform switching with a positive angle and machined surface with micro-threads in the cervical region. Asymmetric and progressive threads in its body with a double thread pitch. Point-ratio geometry on its apical region, Biomimetic Advanced Surface and internal hexagon connection.

Other: Dental Implant Placement

Ocean C.C.®, Avinent Implant System S.L.

ACTIVE COMPARATOR

Dental implant with geometry adapted to the biologic architecture of the bone, with platform switching with a positive angle and machined surface with micro-threads in the cervical region. Asymmetric and progressive threads in its body with a double thread pitch. Point-ratio geometry on its apical region, Biomimetic Advanced Surface and conical connection.

Other: Dental Implant Placement

Interventions

Dental Implant Placement OTHER

Antibiotic prophylaxis will be done. After rinsing with 0.12 % chlorhexidine, patients will receive local anaesthesia. A crestal incision will be done and a mucoperiostic flap will be raised. As the commercial specifies, progressive diameter drills will be used under constant sterile saline irrigation to prepare the implant site. Once finished the drilling sequence, one investigator will open the opaque envelope to know which type of implant, depending on the connection, has to be placed by the surgeon. Dental implant will be placed crestally and depending if it has primary stability or not, it will be leaded submerged or non-submerged. The flap will be repositioned and sutured without tension with 4/0 polyamide. Postoperative instructions and medication will be prescribed and explained.

Also known as: Surgery

Ocean C.C.®, Avinent Implant System S.L.; Ocean E.C.®, Avinent Implant System S.L.; Ocean I.C.®, Avinent Implant System S.L.

Eligibility Criteria

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

You may qualify if:

• Subjects who accept signing voluntarily the informed consent before doing any action related to the study.
• ≥18-years-old patients.
• Edentulous single spaces or edentulous posterior maxilla or mandible (from the first premolar to the second molar) with screw-retained single fixed crowns.
• Single implants successfully osseointegrated placed at least 16 weeks post-extraction.
• O'Leary plaque index and or bleeding on probing ≤25%.
• Dental implants with screwed-retained prosthesis.

You may not qualify if:

• Systemic diseases that can interfere dental implant placement.
• Any contraindication for surgery procedures.
• Heavy smokers (\> 20cig/day).
• Background of drug abuse or other factors such as psychiatric diseases that, in opinion of the examiner, could interfere with the ability of the patient to cooperate and compliment with the study.
• Patients who have had participated with another clinical trial the last 30 days.
• Pregnant women or in lactation.
• Patients with bad oral hygiene or not motivated.
• Probing pockets depths with bleeding of ≥4 mm on a tooth adjacent to the edentulous space.
• Guided bone regeneration required in the same time of the implant placement.

Sponsors & Collaborators

• University of Barcelona: lead

Study Sites (1)

University of Barcelona

L'Hospitalet de Llobregat, Catalonia, 08903, Spain

RECRUITING

Related Publications (15)

• Branemark PI, Adell R, Breine U, Hansson BO, Lindstrom J, Ohlsson A. Intra-osseous anchorage of dental prostheses. I. Experimental studies. Scand J Plast Reconstr Surg. 1969;3(2):81-100. doi: 10.3109/02844316909036699. No abstract available.

  PMID: 4924041 BACKGROUND

• Albrektsson T, Donos N; Working Group 1. Implant survival and complications. The Third EAO consensus conference 2012. Clin Oral Implants Res. 2012 Oct;23 Suppl 6:63-5. doi: 10.1111/j.1600-0501.2012.02557.x.

  PMID: 23062128 BACKGROUND

• Derks J, Tomasi C. Peri-implant health and disease. A systematic review of current epidemiology. J Clin Periodontol. 2015 Apr;42 Suppl 16:S158-71. doi: 10.1111/jcpe.12334.

  PMID: 25495683 BACKGROUND

• Buser D, Ingimarsson S, Dula K, Lussi A, Hirt HP, Belser UC. Long-term stability of osseointegrated implants in augmented bone: a 5-year prospective study in partially edentulous patients. Int J Periodontics Restorative Dent. 2002 Apr;22(2):109-17.

  PMID: 12019706 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

• Oh TJ, Yoon J, Misch CE, Wang HL. The causes of early implant bone loss: myth or science? J Periodontol. 2002 Mar;73(3):322-33. doi: 10.1902/jop.2002.73.3.322.

  PMID: 11922263 BACKGROUND

• Quirynen M, Naert I, van Steenberghe D. Fixture design and overload influence marginal bone loss and fixture success in the Branemark system. Clin Oral Implants Res. 1992 Sep;3(3):104-11. doi: 10.1034/j.1600-0501.1992.030302.x.

  PMID: 1290790 BACKGROUND

• Malevez C, Hermans M, Daelemans P. Marginal bone levels at Branemark system implants used for single tooth restoration. The influence of implant design and anatomical region. Clin Oral Implants Res. 1996 Jun;7(2):162-9. doi: 10.1034/j.1600-0501.1996.070210.x.

  PMID: 9002835 BACKGROUND

• Vidyasagar L, Apse P. Dental implant design and biological effects on bone implant interface. Baltic Dent Maxillofac J. 2004;6:51-4.

  BACKGROUND

• Isidor F. Influence of forces on peri-implant bone. Clin Oral Implants Res. 2006 Oct;17 Suppl 2:8-18. doi: 10.1111/j.1600-0501.2006.01360.x.

  PMID: 16968378 BACKGROUND

• Abrahamsson I, Berglundh T. Effects of different implant surfaces and designs on marginal bone-level alterations: a review. Clin Oral Implants Res. 2009 Sep;20 Suppl 4:207-15. doi: 10.1111/j.1600-0501.2009.01783.x.

  PMID: 19663966 BACKGROUND

• Koo KT, Lee EJ, Kim JY, Seol YJ, Han JS, Kim TI, Lee YM, Ku Y, Wikesjo UM, Rhyu IC. The effect of internal versus external abutment connection modes on crestal bone changes around dental implants: a radiographic analysis. J Periodontol. 2012 Sep;83(9):1104-9. doi: 10.1902/jop.2011.110456. Epub 2011 Dec 6.

  PMID: 22145806 BACKGROUND

• Nishioka RS, de Vasconcellos LG, de Melo Nishioka GN. Comparative strain gauge analysis of external and internal hexagon, Morse taper, and influence of straight and offset implant configuration. Implant Dent. 2011 Apr;20(2):e24-32. doi: 10.1097/ID.0b013e318211fce8.

  PMID: 21448016 BACKGROUND

• Lin MI, Shen YW, Huang HL, Hsu JT, Fuh LJ. A retrospective study of implant-abutment connections on crestal bone level. J Dent Res. 2013 Dec;92(12 Suppl):202S-7S. doi: 10.1177/0022034513510322. Epub 2013 Oct 24.

  PMID: 24158343 BACKGROUND

• Astrand P, Engquist B, Dahlgren S, Grondahl K, Engquist E, Feldmann H. Astra Tech and Branemark system implants: a 5-year prospective study of marginal bone reactions. Clin Oral Implants Res. 2004 Aug;15(4):413-20. doi: 10.1111/j.1600-0501.2004.01028.x.

  PMID: 15248875 BACKGROUND

MeSH Terms

Conditions

Bone Diseases, Metabolic; Bacterial Infections

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Bacterial Infections and Mycoses; Infections

Study Officials

• Rui Figueiredo, DDS, MS, PhD

  University of Barcelona

  STUDY DIRECTOR

• Eduard Valmaseda-Castellón, DDS, MS, PhD

  University of Barcelona

  STUDY CHAIR

• Octavi Camps-Font, DDS, MS

  University of Barcelona

  PRINCIPAL INVESTIGATOR

• Roxana Ghiorghiu, DDS, MS

  University of Barcelona

  PRINCIPAL INVESTIGATOR

• Laura Rubianes-Porta, DDS, MS

  University of Barcelona

  PRINCIPAL INVESTIGATOR

• Anna Piñol-Olea, DDS, MS

  University of Barcelona

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura Rubianes-Porta, DDS, MS

CONTACT

+34630873804; od074964@uic.es

Octavi J. Camps-Font, DDS, MS

CONTACT

+34665980569

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patient will not know the type of connection of his or her implant until the study has finished. Outcome Assessor will be blinded. In the radiographic evaluation the implant-abutment connection will be hidden to assess the marginal bone loss.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Active comparator: Ocean E.C.®, Avinent Implant System S.L., Santpedor, Spain. Active comparator: Ocean I.C.®, Avinent Implant System S.L., Santpedor, Spain. Active comparator: Ocean C.C.®, Avinent Implant System S.L., Santpedor, Spain.

Study Record Dates

• First Submitted: June 21, 2018
• First Posted: March 31, 2020
• Study Start: June 13, 2018
• Primary Completion: June 13, 2021
• Study Completion: December 13, 2021
• Last Updated: March 31, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)