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

NCT01954485 | Unknown Phase 4

• 1 other identifier: Laser-Lok® abutment
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Periimplantitis

Keywords

LaserLok, connective tissue, adhesion

Outcome Measures

Primary Outcomes (1)

• 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).

  3 months

Study Arms (2)

LaserLok abutment

EXPERIMENTAL

Laser microtexturing dental implant abutment

Procedure: Dental implant placement with a final prosthetic abutment

3inOne abutment

ACTIVE COMPARATOR

Standard dental implant abutment

Procedure: Dental implant placement with a final prosthetic abutment

Interventions

Dental implant placement with a final prosthetic abutment PROCEDURE

3inOne abutment; LaserLok abutment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Barcelona: lead
• BioHorizons, Inc.: collaborator

Study Sites (1)

Hospital Odontològic

L'Hospitalet de Llobregat, Barcelona, 89070, Spain

RECRUITING

MeSH Terms

Conditions

Peri-Implantitis; Tissue Adhesions

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Monica Blazquez-Hinarejos, DDS

  Barcelona University

  PRINCIPAL INVESTIGATOR

• Raul Ayuso-Montero, DDS, PhD

  Barcelona University

  STUDY DIRECTOR

• Jose Lopez-Lopez, MD, PhD

  Barcelona University

  STUDY CHAIR

• Cristina Manzanares-Cespedes, MD, PhD

  Barcelona University

  STUDY DIRECTOR

Central Study Contacts

Raul Ayuso-Montero

CONTACT

raulayuso@ub.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical Doctor, Doctor in Dental Science

Study Record Dates

• First Submitted: September 19, 2013
• First Posted: October 1, 2013
• Study Start: January 1, 2013
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2014
• Last Updated: October 1, 2013

Record last verified: 2013-09

Locations

ES (1)