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

Periimplantitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01954485
• Other study ID #: Laser-Lok® abutment
• Status: Recruiting
• Phase: Phase 4
• First received: September 19, 2013
• Last updated: September 26, 2013
• Start date: January 2013
• Est. completion date: September 2014

Study information

• Verified date: September 2013
• Source: University of Barcelona
• Contact: Raul Ayuso-Montero
• Email: raulayuso[@]ub.edu
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 0
• Est. completion date: September 2014
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Peri-Implantitis
• Periimplantitis

Intervention

Procedure:
• Dental implant placement with a final prosthetic abutment

Locations

Country	Name	City	State
Spain	Hospital Odontològic	L'Hospitalet de Llobregat	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
University of Barcelona	BioHorizons, Inc.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes