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

Phase 4

• Conditions: Periimplantitis
• Interventions: Procedure: Dental implant placement with a final prosthetic abutment

• Registration Number: NCT01954485
• Lead Sponsor: University of Barcelona

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.

Study Timeline

• Study Start: 2013-01
• Status Verified: 2013-09
• Primary Completion: 2013-09
• Study First Submitted: 2013-09-19
• Study First Submitted QC: 2013-09-26
• Last Update Submitted: 2013-09-26
• Study First Posted: 2013-10-01
• Last Update Posted: 2013-10-01
• Study Completion: 2014-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
LaserLok abutment	Dental implant placement with a final prosthetic abutment	Laser microtexturing dental implant abutment
3inOne abutment	Dental implant placement with a final prosthetic abutment	Standard dental implant abutment

Primary Outcome Measures

Name	Time	Method
Connective tissue adhesion	3 months	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).

Trial Locations

Locations (1)

Hospital Odontològic; 🇪🇸 L'Hospitalet de Llobregat, Barcelona, Spain