Validation Use of Implants and Abutments With Biologically Oriented Preparation Technique

NCT05051839 | Completed

• 1 other identifier: 14/532
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Implant-Abutment Design

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Radiographic bone level

EXPERIMENTAL

Procedure: Implant surgery and restoration

Peri implant soft tissue volume

EXPERIMENTAL

Procedure: Implant surgery and restoration

Interventions

Implant surgery and restoration PROCEDURE

Implants with two different transmucosal neck configuration are placed.

Peri implant soft tissue volume; Radiographic bone level

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead

Study Sites (1)

Faculty of Dentistry, Unviersidad Complutense de Madrid

Madrid, 28040, Spain

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2021
• First Posted: September 21, 2021
• Study Start: June 15, 2017
• Primary Completion: June 15, 2019
• Study Completion: December 15, 2020
• Last Updated: September 21, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)