Validation Use of Implants and Abutments With Biologically Oriented Preparation Technique

Randomized Clinical Trial to Validate Use of Implants and Abutments With Biologically Oriented Preparation Technique (I.B.O.P.T.)

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.

Study Overview

• Status: Completed
• Conditions: Dental Implant-Abutment Design
• Intervention / Treatment: Procedure: Implant surgery and restoration

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28040
    • Faculty of Dentistry, Unviersidad Complutense de Madrid

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Radiographic bone level	Procedure: Implant surgery and restoration; Implants with two different transmucosal neck configuration are placed.
Experimental: Peri implant soft tissue volume	Procedure: Implant surgery and restoration; Implants with two different transmucosal neck configuration are placed.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Universidad Complutense de Madrid

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2017
• Primary Completion (Actual): June 15, 2019
• Study Completion (Actual): December 15, 2020

Study Registration Dates

• First Submitted: September 15, 2021
• First Submitted That Met QC Criteria: September 15, 2021
• First Posted (Actual): September 21, 2021

Study Record Updates

• Last Update Posted (Actual): September 21, 2021
• Last Update Submitted That Met QC Criteria: September 15, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 14/532

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No