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

September 26, 2013 updated by: Raul Ayuso Montero, D.D.S., University of Barcelona

Histological Differences in the Adhesion of Connective Tissue Around Laser-treated Abutments and Standard Abutments for Dental Implants - Clinical Trial in Humans

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Spain, 89070
        • Recruiting
        • Hospital Odontologic
        • Contact:
        • Principal Investigator:
          • Monica Blazquez-Hinarejos, DDS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Connective tissue adhesion
Time Frame: 3 months

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).
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Barcelona

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

September 1, 2013

Study Completion (Anticipated)

September 1, 2014

Study Registration Dates

First Submitted

September 19, 2013

First Submitted That Met QC Criteria

September 26, 2013

First Posted (Estimate)

October 1, 2013

Study Record Updates

Last Update Posted (Estimate)

October 1, 2013

Last Update Submitted That Met QC Criteria

September 26, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Laser-Lok® abutment

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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