Validation Use of Implants and Abutments With Biologically Oriented Preparation Technique

NCT ID: NCT05051839

Last Updated: 2021-09-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-15
• Study Completion Date: 2020-12-15

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Radiographic bone level

Group Type: EXPERIMENTAL

Implant surgery and restoration

Intervention Type: PROCEDURE

Implants with two different transmucosal neck configuration are placed.

Peri implant soft tissue volume

Group Type: EXPERIMENTAL

Implant surgery and restoration

Intervention Type: PROCEDURE

Implants with two different transmucosal neck configuration are placed.

Interventions

Implant surgery and restoration

Implants with two different transmucosal neck configuration are placed.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad Complutense de Madrid

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Faculty of Dentistry, Unviersidad Complutense de Madrid

Madrid, , Spain

Countries

Spain

Other Identifiers

14/532

Identifier Type: -

Identifier Source: org_study_id