Validation Use of Implants and Abutments With Biologically Oriented Preparation Technique

Not Applicable

Completed

• Conditions: Dental Implant-Abutment Design
• Interventions: Procedure: Implant surgery and restoration

• Registration Number: NCT05051839
• Lead Sponsor: Universidad Complutense de Madrid

Brief Summary

This randomized clinical trial aims to validate and to establish indications for using implants with biological oriented preparation technique (I.B.O.P.T.) for implant supported prosthetic treatment as an option looking for better stability and control of associated soft and hard tissues compared with conventional implants and conventional abutments with finishing lines preparation technique.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-15
• Primary Completion: 2019-06-15
• Study Completion: 2020-12-15
• Status Verified: 2021-09
• Study First Submitted: 2021-09-15
• Study First Submitted QC: 2021-09-15
• Last Update Submitted: 2021-09-15
• Study First Posted: 2021-09-21
• Last Update Posted: 2021-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Male or female ≥18 years old.
• Need for implant-supported fixed prosthesis in the posterior area of the upper or lower jaw (up to 2 implants and three units bridge);
• Adequate bone quality and quantity at the implant site to allow the insertion of Sweden and Martina Premium or Prama (Due Carrare, Padova, Italy), of diameters 3.8, 4.25 or 5 mm and lengths between 10 and 13 mm.
• Healthy ASA type I and II patients.
• Full-mouth plaque index <20.

Exclusion Criteria

• Smokers ≥10 cigarettes/day.
• Presence of implant-supported restorations adjacent to the study site.
• Active periodontitis defined as the presence of pockets with probing depth (PD) ≥5 mm and bleeding on probing (BoP).
• Systemic medication that contraindicates surgery (bisphosphonates or steroid therapy).
• Uncontrolled diabetes.
• Severe bruxism.
• Pregnancy.
• Previous history of radiotherapy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Radiographic bone level	Implant surgery and restoration	-
Peri implant soft tissue volume	Implant surgery and restoration	-

Primary Outcome Measures

Name	Time	Method
Marginal bone level	Baseline to 12-months follow-up	Changes in interproximal marginal bone level with standardization of the radiograph
Soft tissue volumetric analysis	Baseline to 12-motnhs follow-up	Soft tissue volumetric analysis with digital impressiones taken at baseline and at 12-month follow-up visit

Trial Locations

Locations (1)

Faculty of Dentistry, Unviersidad Complutense de Madrid; 🇪🇸 Madrid, Spain