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

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01954485
Enrollment
Unknown
Registered
2013-10-01
Start date
2013-01-31
Completion date
2014-09-30
Last updated
2013-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periimplantitis

Keywords

LaserLok, connective tissue, adhesion

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.

Interventions

PROCEDUREDental implant placement with a final prosthetic abutment

Sponsors

BioHorizons, Inc.
CollaboratorINDUSTRY
University of Barcelona
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
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

* 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

Design outcomes

Primary

MeasureTime frameDescription
Connective tissue adhesion3 monthsAt 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).

Countries

Spain

Contacts

Primary ContactRaul Ayuso-Montero
raulayuso@ub.edu

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026