Marginal Bone Level Around Implants With Definitive Abutments

NCT04230837 | Completed DMC

• 1 other identifier: PER-ECL-2015-05
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the present study was to evaluate the peri-implant crestal bone level around implants placed 1.5 mm subcrestally, with a 1 mm or 3 mm definitive abutment height at the time of implant placement after 1 year. Patients were selected from the Department of Periodontology at Universitat Internacional de Catalunya. X-rays were taken at the time of implant placement, 8-12 weeks after placement, after screwing the provisional rehabilitation and at 12 months. An examiner indicated the crestal marginal bone level, the marginal bone level of the implant, and the marginal bone level of the abutment . The examiner, independent to the study, carried out the radiographic analysis using the Image J software on periapical radiographs.

Conditions

Implant Site Reaction

Keywords

definitive implant abutment; interproximal bone loss; soft tissue

Outcome Measures

Primary Outcomes (2)

• Change from Baseline Bone Loss, at 8-12 weeks and 1 year.

  X-rays were taken at the time of implant placement, 8-12 weeks after placement, after screwing the provisional rehabilitation and at 12 months.

  baseline, 8-12 weeks and 1 year

• Mucosal thickness (MT)

  Mucosal thickness (MT) before placement of the implant using a PCP-UNC15 periodontal probe. This measure will be compared with the abutment high and bone loss at 1 year.

  baseline

Secondary Outcomes (4)

• Change from Baseline the resonance frequency analysis at 8-12 weeks and 1 year.

  baseline, 8-12 weeks and 1 year

• Plaque index at 1 year

  1 year

• Bleeding on probing at 1 year

  1 year

• Probing depth at 1 year

  1 year

Study Arms (2)

A: Abutments of 1 mm

EXPERIMENTAL

Definitive abutments of 1 mm height were located.

Device: Inmediate abutment height

B: Abutments of 3 mm

EXPERIMENTAL

Definitive abutments of 3 mm height were located.

Device: Inmediate abutment height

Interventions

Inmediate abutment height DEVICE

The placement of the implant was done following the manufacturing protocol and using a surgical guide according to the radiological guide previously used. At this time, the Permanent® abutment of 1 or 3 mm was chosen randomly and was placed at 35 Ncm.

A: Abutments of 1 mm; B: Abutments of 3 mm

Eligibility Criteria

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

You may qualify if:

• Male or female ≥18 years old;
• Controlled ASA1 or ASA2 patient;
• Healthy periodontium or with controlled periodontal disease;
• Need for rehabilitation with implants in partially posterior edentulous sextants;
• Full Mouth Plaque Score (FMPS) less than 20% at the time of surgery;
• Collaborating patients.
• According to the implant location:
• Healed posterior sites, with a minimum of 2 months post-extraction;
• Ridge width of 7 mm or more and of 10 mm of height to the mandibular nerve and 8 mm to the maxillary sinus;
• Minimum keratinized mucosa (KM) width of 4 mm;
• Antagonist dentition having a fixed restoration or natural teeth, (5) restorative space greater than 5 mm.

You may not qualify if:

• Patients with endocrine, immunological or metabolic alterations;
• Pregnancy, allergy to any metallic component of the implant;
• Drug consumption or alcoholism;
• Tobacco ≥10 cig/d and
• Severe bruxism and TMJ pathology.
• According to the implant location:
• Require regeneration techniques;
• Width of KM less than 2 mm at any implant site;
• Infections in the treatment area;
• Absence of implant primary stability and
• Being unable to perform prosthetically guided screw-retained restorations.

Sponsors & Collaborators

• Universitat Internacional de Catalunya: lead

Study Sites (1)

Universitat Internacional de Catalunya

Barcelona, 08195, Spain

Location

Related Publications (12)

• Blanco J, Pico A, Caneiro L, Novoa L, Batalla P, Martin-Lancharro P. Effect of abutment height on interproximal implant bone level in the early healing: A randomized clinical trial. Clin Oral Implants Res. 2018 Jan;29(1):108-117. doi: 10.1111/clr.13108. Epub 2017 Dec 8.

  PMID: 29222809 BACKGROUND

• Borges T, Leitao B, Pereira M, Carvalho A, Galindo-Moreno P. Influence of the abutment height and connection timing in early peri-implant marginal bone changes: A prospective randomized clinical trial. Clin Oral Implants Res. 2018 Sep;29(9):907-914. doi: 10.1111/clr.13343.

  PMID: 30259582 BACKGROUND

• Chen Z, Lin CY, Li J, Wang HL, Yu H. Influence of abutment height on peri-implant marginal bone loss: A systematic review and meta-analysis. J Prosthet Dent. 2019 Jul;122(1):14-21.e2. doi: 10.1016/j.prosdent.2018.10.003. Epub 2019 Feb 16.

  PMID: 30782461 BACKGROUND

• Galindo-Moreno P, Leon-Cano A, Ortega-Oller I, Monje A, Suarez F, OValle F, Spinato S, Catena A. Prosthetic Abutment Height is a Key Factor in Peri-implant Marginal Bone Loss. J Dent Res. 2014 Jul;93(7 Suppl):80S-85S. doi: 10.1177/0022034513519800. Epub 2014 Mar 12.

  PMID: 24621670 BACKGROUND

• Linkevicius T, Apse P, Grybauskas S, Puisys A. Reaction of crestal bone around implants depending on mucosal tissue thickness. A 1-year prospective clinical study. Stomatologija. 2009;11(3):83-91.

  PMID: 19996674 BACKGROUND

• Linkevicius T, Puisys A, Steigmann M, Vindasiute E, Linkeviciene L. Influence of Vertical Soft Tissue Thickness on Crestal Bone Changes Around Implants with Platform Switching: A Comparative Clinical Study. Clin Implant Dent Relat Res. 2015 Dec;17(6):1228-36. doi: 10.1111/cid.12222. Epub 2014 Mar 28.

  PMID: 24673875 BACKGROUND

• Molina A, Sanz-Sanchez I, Martin C, Blanco J, Sanz M. The effect of one-time abutment placement on interproximal bone levels and peri-implant soft tissues: a prospective randomized clinical trial. Clin Oral Implants Res. 2017 Apr;28(4):443-452. doi: 10.1111/clr.12818. Epub 2016 Mar 25.

  PMID: 27016157 BACKGROUND

• Novoa L, Batalla P, Caneiro L, Pico A, Linares A, Blanco J. Influence of Abutment Height on Maintenance of Peri-implant Crestal Bone at Bone-Level Implants: A 3-Year Follow-up Study. Int J Periodontics Restorative Dent. 2017 Sep/Oct;37(5):721-727. doi: 10.11607/prd.2762.

  PMID: 28817138 BACKGROUND

• Puisys A, Linkevicius T. The influence of mucosal tissue thickening on crestal bone stability around bone-level implants. A prospective controlled clinical trial. Clin Oral Implants Res. 2015 Feb;26(2):123-9. doi: 10.1111/clr.12301. Epub 2013 Dec 9.

  PMID: 24313250 BACKGROUND

• Spinato S, Stacchi C, Lombardi T, Bernardello F, Messina M, Zaffe D. Biological width establishment around dental implants is influenced by abutment height irrespective of vertical mucosal thickness: A cluster randomized controlled trial. Clin Oral Implants Res. 2019 Jul;30(7):649-659. doi: 10.1111/clr.13450. Epub 2019 May 12.

  PMID: 31033035 BACKGROUND

• Vervaeke S, Dierens M, Besseler J, De Bruyn H. The influence of initial soft tissue thickness on peri-implant bone remodeling. Clin Implant Dent Relat Res. 2014 Apr;16(2):238-47. doi: 10.1111/j.1708-8208.2012.00474.x. Epub 2012 Jul 3.

  PMID: 22758656 BACKGROUND

• Canullo L, Camacho-Alonso F, Tallarico M, Meloni SM, Xhanari E, Penarrocha-Oltra D. Mucosa Thickness and Peri-implant Crestal Bone Stability: A Clinical and Histologic Prospective Cohort Trial. Int J Oral Maxillofac Implants. 2017 May/June;32(5):675-681. doi: 10.11607/jomi.5349. Epub 2017 Mar 15.

  PMID: 28296981 BACKGROUND

Study Officials

• Jose Nart

  Universitat Internacional de Catalunya

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The surgeon was unaware of the abutment height until after the insertion of the implant. Patients were unknown the abutment group. The examiner, independent to the study, carried out the radiographic analysis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman and Program Director, Department of Periodontology at UIC Barcelona

Model Details: Randomized controlled prospective study

Study Record Dates

• First Submitted: November 18, 2019
• First Posted: January 18, 2020
• Study Start: January 1, 2017
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2019
• Last Updated: January 18, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)