Bacterial Microleakage and Bone Loss in Internal Connection Dental Implants Based on the Type of Abutment Used in Zirconia Partial Fixed Prosthesis: in Vivo Study

NCT06156111 | Unknown

• 1 other identifier: 18/426-E
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial aims to observe if there are differences in bacterial micro-filtration on interfaces and to evaluate if there are differences in the occurrence of peri-implant diseases and bone loss in fixed partial monolithic zirconia CAD/CAM implantsupported prostheses with and without abutment in patients at the Advanced Implant Prosthetics Clinic of the Complutense University of Madrid, of both sexes, over 18 years of age, whose treatment plan is based on the replacement of dental pieces with two fixed partial dentures on implants, in such a way that the study will be performed "split mouth" rehabilitating one of them with zirconia bridges on attachments with connection and others with Zirconia bridges with flat attachments or without connection. The main question it aims to answer is whether the not use of abutment influence bacterial micro-leakage and the development of peri-implant diseases and bone loss at that level in fixed partial monolithic zirconia CAD/CAM prothesis. Participants will:

• Receive two fixed partial monolithic zirconia CAD/CAM prothesis, one will be attached to an abutment (control group) and the other not (test group)
• Subsequently, control appointments of the fixed implant supported prosthesis treatment will be performed (1, 3,6, 12 and 24 months) and radiographies will be made with the parallelizing device attached by the silicone key. Researchers will compare fixed partial monolithic zirconia CAD/CAM implant-supported prostheses with and without abutment to see:
• Differences in bacterial micro-leakage on interfaces.
• Occurrence of peri-implant diseases and bone loss

Conditions

Jaw, Edentulous, Partially

Keywords

Dental implants; Dental abutments; Dental prosthesis; Dental implant-abutment; Implant-Abutment Connections

Outcome Measures

Primary Outcomes (3)

• Bacterial micro-filtration: Bacterial load analysis

  Samples will be obtained at the conection of the study control and study test from each patient. Samples will be taken with two consecutive sterile medium paper-points (#30, Maillefer, Ballaigues, Switzerland) that were kept in place for 30 s and then transferred into a screw-capped vial. Samples will be transported to the microbiology laboratory within 2 h and stored in deep freezing (-80ºC). Samples will be processed for multiplex RTPCR for detection of total anaerobic counts and counts of selected periodontal pathogens Data will be expressed in colony-forming units (CFU) per mL of the original sample.

  2 years

• Bone level change

  On the standardized peri-apical radiographs implant bone levels will be evaluated. The reference point for the bone level measurement will be the implant shoulder. The bone level will be measured as the distance between the implant shoulder and the first visible bone contact on the implant. Mean bone level changes between two time-points will be computed by subtracting the average bone level from one visit with the other.

  2 years

• Peri-implant pathologies development

  The peri-implant pathologies development will be evaluated through the presence of unhealthy clinical records on probing pocket depth and bleeding on probing.

  2 years

Secondary Outcomes (7)

• Probing pocket depth (PPD)

  2 years

• Bleeding on Probing (BoP)

  2 years

• Inter-proximal contact point

  2 years

• Prosthetic mechanical behavior

  2 years

• Patient satisfaction

  2 years

Study Arms (2)

Transepithelial abutment

OTHER

The patients randomized to the transepithelial abutment group will receive a fixed screw implant-supported zirconia prosthesis which will be attached to the implants through an implant-abutment connection.

Device: Transepithelial abutment group

Direct to implant

EXPERIMENTAL

The patients randomized to the direct to implant group will receive a fixed screw implant-supported zirconia prosthesis which will be attached direct to the implants connection.

Device: Direct to implant group

Interventions

Transepithelial abutment group DEVICE

Before completing the essential clinical data registration to produce an individual patient-oriented prosthesis, trans-epithelial abutments on the implants randomized to this group will be put at the torque the manufacturer recommends (30 Ncm typically), according to the appropriate gingival height and then the fixed implant-supported monolithic zirconia will be placed at the torque of 15 Ncm

Also known as: Control Group

Transepithelial abutment

Direct to implant group DEVICE

It will be registered the essential clinical data registration to produce an individual patient-oriented prosthesis, and then the fixed implant-supported monolithic zirconia will be placed at the torque of 30 Ncm.

Also known as: Test Group

Direct to implant

Eligibility Criteria

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

You may qualify if:

• Patients susceptible to treatment with implants.
• Being over 18 years old.
• Not being severe smokers (\>20 cigarettes/day)
• Not having diseases that can affect bone metabolism, such as arthritis and osteoporosis, and not having uncontrolled systemic diseases.

You may not qualify if:

• Any contraindications for oral surgical procedures.
• Conditions or circumstances that, in the opinion of the investigator, would preclude completion of participation in the study or interfere with the analysis of the study results.

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead

Study Sites (1)

School of Dentistry, Complutense University. Pza Ramón y Cajal s/n.

Madrid, 28040, Spain

Location

Related Publications (18)

• Smith NA, Turkyilmaz I. Evaluation of the sealing capability of implants to titanium and zirconia abutments against Porphyromonas gingivalis, Prevotella intermedia, and Fusobacterium nucleatum under different screw torque values. J Prosthet Dent. 2014 Sep;112(3):561-7. doi: 10.1016/j.prosdent.2013.11.010. Epub 2014 Mar 20.

  PMID: 24656409 BACKGROUND

• Baldassarri M, Hjerppe J, Romeo D, Fickl S, Thompson VP, Stappert CF. Marginal accuracy of three implant-ceramic abutment configurations. Int J Oral Maxillofac Implants. 2012 May-Jun;27(3):537-43.

  PMID: 22616046 BACKGROUND

• Larrucea C, Conrado A, Olivares D, Padilla C, Barrera A, Lobos O. Bacterial microleakage at the abutment-implant interface, in vitro study. Clin Implant Dent Relat Res. 2018 Jun;20(3):360-367. doi: 10.1111/cid.12589. Epub 2018 Feb 15.

  PMID: 29446238 BACKGROUND

• Alves DCC, de Carvalho PSP, Elias CN, Vedovatto E, Martinez EF. In vitro analysis of the microbiological sealing of tapered implants after mechanical cycling. Clin Oral Investig. 2016 Dec;20(9):2437-2445. doi: 10.1007/s00784-016-1744-0. Epub 2016 Feb 20.

  PMID: 26895757 BACKGROUND

• Elshiyab SH, Nawafleh N, George R. Survival and testing parameters of zirconia-based crowns under cyclic loading in an aqueous environment: A systematic review. J Investig Clin Dent. 2017 Nov;8(4). doi: 10.1111/jicd.12261. Epub 2017 Mar 19.

  PMID: 28317331 BACKGROUND

• Gehrke SA, Delgado-Ruiz RA, Prados Frutos JC, Prados-Privado M, Dedavid BA, Granero Marin JM, Calvo Guirado JL. Misfit of Three Different Implant-Abutment Connections Before and After Cyclic Load Application: An In Vitro Study. Int J Oral Maxillofac Implants. 2017 Jul/Aug;32(4):822-829. doi: 10.11607/jomi.5629.

  PMID: 28708914 BACKGROUND

• Bressan E, Stocchero M, Jimbo R, Rosati C, Fanti E, Tomasi C, Lops D. Microbial Leakage at Morse Taper Conometric Prosthetic Connection: An In Vitro Investigation. Implant Dent. 2017 Oct;26(5):756-761. doi: 10.1097/ID.0000000000000657.

  PMID: 28945671 BACKGROUND

• Guerra E, Pereira C, Faria R, Jorge AO, Bottino MA, de Melo RM. The Impact of Conical and Nonconical Abutments on Bacterial Infiltration at the Implant-Abutment Interface. Int J Periodontics Restorative Dent. 2016 Nov/Dec;36(6):825-831. doi: 10.11607/prd.2779.

  PMID: 27740643 BACKGROUND

• Butignon LE, Basilio Mde A, Pereira Rde P, Arioli Filho JN. Influence of three types of abutments on preload values before and after cyclic loading with structural analysis by scanning electron microscopy. Int J Oral Maxillofac Implants. 2013 May-Jun;28(3):e161-70. doi: 10.11607/jomi.2481.

  PMID: 23748335 BACKGROUND

• Butignon LE, de Almeida Basilio M, Santo JS, Arioli Filho JN. Vertical Misfit of Single-Implant Abutments Made from Different Materials Under Cyclic Loading. Int J Oral Maxillofac Implants. 2016 Sep-Oct;31(5):1017-22. doi: 10.11607/jomi.4477.

  PMID: 27632255 BACKGROUND

• Larrucea Verdugo C, Jaramillo Nunez G, Acevedo Avila A, Larrucea San Martin C. Microleakage of the prosthetic abutment/implant interface with internal and external connection: in vitro study. Clin Oral Implants Res. 2014 Sep;25(9):1078-83. doi: 10.1111/clr.12217. Epub 2013 Jul 4.

  PMID: 23822097 BACKGROUND

• Colpani JT, Borba M, Della Bona A. Evaluation of marginal and internal fit of ceramic crown copings. Dent Mater. 2013 Feb;29(2):174-80. doi: 10.1016/j.dental.2012.10.012. Epub 2012 Dec 4.

  PMID: 23218747 BACKGROUND

• Kim KB, Kim JH, Kim WC, Kim JH. Three-dimensional evaluation of gaps associated with fixed dental prostheses fabricated with new technologies. J Prosthet Dent. 2014 Dec;112(6):1432-6. doi: 10.1016/j.prosdent.2014.07.002. Epub 2014 Sep 11.

  PMID: 25218032 BACKGROUND

• Fernandez M, Delgado L, Molmeneu M, Garcia D, Rodriguez D. Analysis of the misfit of dental implant-supported prostheses made with three manufacturing processes. J Prosthet Dent. 2014 Feb;111(2):116-23. doi: 10.1016/j.prosdent.2013.09.006. Epub 2013 Oct 28.

  PMID: 24176182 BACKGROUND

• Tartaglia GM, Sidoti E, Sforza C. Seven-year prospective clinical study on zirconia-based single crowns and fixed dental prostheses. Clin Oral Investig. 2015 Jun;19(5):1137-45. doi: 10.1007/s00784-014-1330-2. Epub 2014 Oct 12.

  PMID: 25304166 BACKGROUND

• Guess PC, Att W, Strub JR. Zirconia in fixed implant prosthodontics. Clin Implant Dent Relat Res. 2012 Oct;14(5):633-45. doi: 10.1111/j.1708-8208.2010.00317.x. Epub 2010 Dec 22.

  PMID: 21176095 BACKGROUND

• Lang NP, Berglundh T; Working Group 4 of Seventh European Workshop on Periodontology. Periimplant diseases: where are we now?--Consensus of the Seventh European Workshop on Periodontology. J Clin Periodontol. 2011 Mar;38 Suppl 11:178-81. doi: 10.1111/j.1600-051X.2010.01674.x.

  PMID: 21323713 BACKGROUND

• Zarone F, Russo S, Sorrentino R. From porcelain-fused-to-metal to zirconia: clinical and experimental considerations. Dent Mater. 2011 Jan;27(1):83-96. doi: 10.1016/j.dental.2010.10.024. Epub 2010 Nov 21.

  PMID: 21094996 BACKGROUND

MeSH Terms

Conditions

Jaw, Edentulous, Partially

Interventions

Control Groups

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Miguel Gómez Polo, DDS, PhD

  UComplutense de Madrid

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The assessment and the measurements will be performed by a separate person, not the operator. The patient will not know in which quadrant the abutments will be placed or not.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Conservative Dentistry and Prosthodontics

Model Details: Prospective double-blinded, randomized, paired sample (split-mouth).

Study Record Dates

• First Submitted: November 20, 2023
• First Posted: December 5, 2023
• Study Start: February 26, 2020
• Primary Completion: November 30, 2022
• Study Completion: November 30, 2023
• Last Updated: December 5, 2023

Record last verified: 2023-12

Locations

ES (1)