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

Primary Purpose

Periimplantitis

Status
Unknown status
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Dental implant placement with a final prosthetic abutment
Sponsored by
University of Barcelona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Periimplantitis focused on measuring LaserLok, connective tissue, adhesion

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Hospital OdontològicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

LaserLok abutment

3inOne abutment

Arm Description

Laser microtexturing dental implant abutment

Standard dental implant abutment

Outcomes

Primary Outcome Measures

Connective tissue adhesion
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).

Secondary Outcome Measures

Full Information

First Posted
September 19, 2013
Last Updated
September 26, 2013
Sponsor
University of Barcelona
Collaborators
BioHorizons, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01954485
Brief Title
Adhesion of Connective Tissue Around Laser-treated Abutments for Dental Implants - Clinical Trial in Humans
Official Title
Histological Differences in the Adhesion of Connective Tissue Around Laser-treated Abutments and Standard Abutments for Dental Implants - Clinical Trial in Humans
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Unknown status
Study Start Date
January 2013 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Barcelona
Collaborators
BioHorizons, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periimplantitis
Keywords
LaserLok, connective tissue, adhesion

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
Participant
Allocation
Randomized

8. Arms, Groups, and Interventions

Arm Title
LaserLok abutment
Arm Type
Experimental
Arm Description
Laser microtexturing dental implant abutment
Arm Title
3inOne abutment
Arm Type
Active Comparator
Arm Description
Standard dental implant abutment
Intervention Type
Procedure
Intervention Name(s)
Dental implant placement with a final prosthetic abutment
Primary Outcome Measure Information:
Title
Connective tissue adhesion
Description
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).
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Raul Ayuso-Montero
Email
raulayuso@ub.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Monica Blazquez-Hinarejos, DDS
Organizational Affiliation
Barcelona University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Raul Ayuso-Montero, DDS, PhD
Organizational Affiliation
Barcelona University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jose Lopez-Lopez, MD, PhD
Organizational Affiliation
Barcelona University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Cristina Manzanares-Cespedes, MD, PhD
Organizational Affiliation
Barcelona University
Official's Role
Study Director
Facility Information:
Facility Name
Hospital Odontològic
City
L'Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
89070
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raul Ayuso-Montero, Associate Professor
Email
raulayuso@ub.edu
First Name & Middle Initial & Last Name & Degree
Monica Blazquez-Hinarejos, DDS

12. IPD Sharing Statement

Learn more about this trial

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

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