Status unknownNCT01954485Updated Oct 1, 2013

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

A Phase 4 interventional study of Dental implant placement with a final prosthetic abutment in Periimplantitis, sponsored by University of Barcelona. Status unknown at 1 site in Spain. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-10-01.

Sponsored by University of Barcelona · Phase 4, Interventional, and Basic science

The sponsor has not verified this record recently (last verified Sep 2013), so the status shown — last known as Recruiting — may be out of date.

Phase: Phase 4
Study type: Interventional
Allocation: Randomized
Ages: 18 Years to 80 Years
Sex: All

Study 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.

Read the 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.

Conditions studied

Periimplantitis

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Keywords

LaserLok, connective tissue, adhesion

In context

Peri-Implantitis

304 studies on the registry are indexed under Peri-Implantitis; 84 are open to participants now.

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Lead sponsor

University of Barcelona is the lead sponsor of 95 studies on the registry; 27 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 80 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

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

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 design

Phase: Phase 4
Primary purpose: Basic science
Allocation: Randomized
Intervention model: Factorial assignment
Masking: Single (Participant)

Study arms

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

Interventions

ProcedureDental implant placement with a final prosthetic abutment

What researchers measure

Primary outcomes

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).
Time frame: 3 months

Study locations

1 of 1 sites recruiting

Hospital Odontològic
L'Hospitalet de Llobregat, Barcelona 89070, Spain
- Raul Ayuso-Montero, Associate Professor · Contact · raulayuso@ub.edu
- Monica Blazquez-Hinarejos, DDS · Principal investigator
Recruiting

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Oct 1, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01954485
Lead sponsor: University of Barcelona
Collaborators: BioHorizons, Inc.
Responsible party: Raul Ayuso Montero, D.D.S. (Physical Doctor, Doctor in Dental Science, University of Barcelona) — Principal investigator
First posted: Oct 1, 2013
Start date: Jan 2013
Primary completion: Sep 2013
Completion: Sep 2014 (estimated)
Last update: Oct 1, 2013

Study contacts

Raul Ayuso-Montero

Contact

raulayuso@ub.edu

Monica Blazquez-Hinarejos, DDS

principal investigator · Barcelona University

Raul Ayuso-Montero, DDS, PhD

study director · Barcelona University

Jose Lopez-Lopez, MD, PhD

study chair · Barcelona University

Cristina Manzanares-Cespedes, MD, PhD

study director · Barcelona University

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2013. You cannot join it, but the record below documents what was studied.

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