Adhesion of Connective Tissue Around Laser-treated Abutments for Dental Implants - Clinical Trial in Humans

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by University of Barcelona
Sponsor:
Collaborator:
BioHorizons, Inc.
Information provided by (Responsible Party):
Raul Ayuso Montero, D.D.S., University of Barcelona
ClinicalTrials.gov Identifier:
NCT01954485
First received: September 19, 2013
Last updated: September 26, 2013
Last verified: September 2013
  Purpose

This study aims to demonstrate the histological differences in the connective tissue surrounding laser-treated abutments and untreated abutments in humans.

Working hypothesis: There are differences in the adhesion of collagen fibres around implant abutments with laser-produced microgrooves and standard abutments.


Condition Intervention Phase
Periimplantitis
Procedure: Dental implant placement with a final prosthetic abutment
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: Histological Differences in the Adhesion of Connective Tissue Around Laser-treated Abutments and Standard Abutments for Dental Implants - Clinical Trial in Humans

Resource links provided by NLM:


Further study details as provided by University of Barcelona:

Primary Outcome Measures:
  • Connective tissue adhesion [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

    At 90 days after the first operation, a second surgical procedure will be scheduled. A cilindrical scalpel of a diameter 2 mm greater than the abutment is used to make the incision and the abutment unscrewed together with the gingival insertion surrounding it for histological study.

    The attachment of connective tissue to the abutments will be determined by microscopic observation. It will be a binary variable: attachment IS present (YES-A); attachment IS NOT present (NO-A).



Study Start Date: January 2013
Estimated Study Completion Date: September 2014
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LaserLok abutment
Laser microtexturing dental implant abutment
Procedure: Dental implant placement with a final prosthetic abutment
Active Comparator: 3inOne abutment
Standard dental implant abutment
Procedure: Dental implant placement with a final prosthetic abutment

Detailed Description:

All patients will receive both abutment systems. The assignment of the abutments to each of the implants will be made randomly using SPSS 15.0 (SPSS Inc., Chicago, Il, United States) software.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • patient must have partial edentulism of at least 2 teeth
  • patients that have scheduled treatment for the placement of at least 2 implants
  • patients with favourable attached gingiva
  • patients without systemic diseases that would prevent the emplacement of implants
  • patient must accept participation in the study by signing an informed consent form

Exclusion Criteria:

  • smokers of 1 or more cigarettes per day
  • patients who suffer from any known condition that could be an absolute or relative contraindication to dental implant placement
  • patients requiring any additional surgical technique for bone or gum graft in order to insert the dental implant
  • patients who refuse to be included in the study or do not sign the informed consent form
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01954485

Contacts
Contact: Raul Ayuso-Montero raulayuso@ub.edu

Locations
Spain
Hospital Odontològic Recruiting
L'Hospitalet de Llobregat, Barcelona, Spain, 89070
Contact: Raul Ayuso-Montero, Associate Professor       raulayuso@ub.edu   
Principal Investigator: Monica Blazquez-Hinarejos, DDS         
Sponsors and Collaborators
University of Barcelona
BioHorizons, Inc.
Investigators
Principal Investigator: Monica Blazquez-Hinarejos, DDS Barcelona University
Study Director: Raul Ayuso-Montero, DDS, PhD Barcelona University
Study Chair: Jose Lopez-Lopez, MD, PhD Barcelona University
Study Director: Cristina Manzanares-Cespedes, MD, PhD Barcelona University
  More Information

No publications provided

Responsible Party: Raul Ayuso Montero, D.D.S., Physical Doctor, Doctor in Dental Science, University of Barcelona
ClinicalTrials.gov Identifier: NCT01954485     History of Changes
Other Study ID Numbers: Laser-Lok® abutment
Study First Received: September 19, 2013
Last Updated: September 26, 2013
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by University of Barcelona:
LaserLok, connective tissue, adhesion

Additional relevant MeSH terms:
Peri-Implantitis
Mouth Diseases
Stomatognathic Diseases
Periodontal Diseases

ClinicalTrials.gov processed this record on October 01, 2014