Clinical trial NCT04328051: Influence of the Implant-prosthetic Connection in the Marginal Bone Loss and Bacterial Leakage
Official title: Influence of the Implant-prosthetic Connection in the Marginal Bone Loss and Bacterial Leakage. A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dental Implant
Bone Loss
Bacterial Infections
Keywords: Dental Implant
Internal Connection
External Connection
Conical Connection
Marginal Bone Loss
Implant Prosthetic Connection
Bacterial Leakage
Lead sponsor: University of Barcelona
Sponsor class: OTHER
First posted: 2020-03-31
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed description: Location: This study is going to take place in the Dentistry Hospital of the University of Barcelona (Campus of Bellvitge).

Study subjects: The sample (105 patients) consists of patients with single tooth edentulous spaces or posterior maxillary and/or mandible edentulous spaces in need of dental implants with screw-retained single fixed crowns. All of them are being properly informed about the study according to the Comité Ético (CEIC) del Hospital Odontològic Universitat de Barcelona guidelines, and informed consent must be signed prior to the interventions.

Material: Registration papers for the study, dental implants, surgery material, prosthetic components, Florida Probe Software®, Periapical x-rays, computer, Software Stata 14 and Software ImageJ®.

Determinations: Clinical, radiographic and microbiologic measures since implant placement, prosthesis placement and 3, 6, 9 and 12 months after it.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in Vertical Marginal Bone Loss (VMBL)
timeFrame: Since implant placement (Timing 0) through study completion (Timing 5), an average of 1 year.
Secondary outcomes:
measure: Vertical Marginal Bone Loss Tax
timeFrame: 12 months after prosthesis placement.
measure: Early implant failure
timeFrame: Since implant placement (Timing 0) through prosthesis placement (Timing 1).
measure: Late implant failure
timeFrame: Since prosthesis placement (Timing 1) through study completion (Timing 5), an average of 1 year.
measure: Probing pocket depth
timeFrame: Since prosthesis placement (Timing 1) through study completion (Timing 5), an average of 1 year.
measure: Mucosal recession
timeFrame: Since prosthesis placement (Timing 1) through study completion (Timing 5), an average of 1 year.
measure: Mucosal hyperplasia
timeFrame: Since prosthesis placement (Timing 1) through study completion (Timing 5), an average of 1 year.
measure: Clinical attachment level
timeFrame: Since prosthesis placement (Timing 1) through study completion (Timing 5), an average of 1 year.
measure: O'Leary plaque index
timeFrame: First visit
measure: Bleeding on probing
timeFrame: Since first visit through study completion (Timing 5), an average of 1 year.
measure: Suppuration on probing
timeFrame: Since first visit through study completion (Timing 5), an average of 1 year.
measure: Prosthetic complications
timeFrame: Since prosthesis placement (Timing 1) through study completion (Timing 5), an average of 1 year.
measure: Bacterial leakage
timeFrame: 12 months after prosthesis placement.
Other outcomes:
Locations:
city: L'Hospitalet De Llobregat
country: Spain
facility: University of Barcelona
state: Catalunya
Study officials:
affiliation: University of Barcelona
name: Rui Figueiredo, DDS, MS, PhD
role: STUDY_DIRECTOR
affiliation: University of Barcelona
name: Eduard Valmaseda-Castellón, DDS, MS, PhD
role: STUDY_CHAIR
affiliation: University of Barcelona
name: Octavi Camps-Font, DDS, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Barcelona
name: Roxana Ghiorghiu, DDS, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Barcelona
name: Laura Rubianes-Porta, DDS, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Barcelona
name: Anna Piñol-Olea, DDS, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
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: 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.
citation: 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.
citation: 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.
citation: Vidyasagar L, Apse P. Dental implant design and biological effects on bone implant interface. Baltic Dent Maxillofac J. 2004;6:51-4.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.