MedDataX Logo

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

NCT ID: NCT01954485

Last Updated: 2013-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2014-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Periimplantitis

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

LaserLok, connective tissue, adhesion

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

LaserLok abutment

Laser microtexturing dental implant abutment

Group Type EXPERIMENTAL

Dental implant placement with a final prosthetic abutment

Intervention Type PROCEDURE

3inOne abutment

Standard dental implant abutment

Group Type ACTIVE_COMPARATOR

Dental implant placement with a final prosthetic abutment

Intervention Type PROCEDURE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dental implant placement with a final prosthetic abutment

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

BioHorizons, Inc.

INDUSTRY

Sponsor Role collaborator

University of Barcelona

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Raul Ayuso Montero, D.D.S.

Physical Doctor, Doctor in Dental Science

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Monica Blazquez-Hinarejos, DDS

Role: PRINCIPAL_INVESTIGATOR

Barcelona University

Raul Ayuso-Montero, DDS, PhD

Role: STUDY_DIRECTOR

Barcelona University

Jose Lopez-Lopez, MD, PhD

Role: STUDY_CHAIR

Barcelona University

Cristina Manzanares-Cespedes, MD, PhD

Role: STUDY_DIRECTOR

Barcelona University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hospital Odontològic

L'Hospitalet de Llobregat, Barcelona, Spain

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Spain

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Raul Ayuso-Montero

Role: CONTACT

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Raul Ayuso-Montero, Associate Professor

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Laser-Lok® abutment

Identifier Type: -

Identifier Source: org_study_id