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.)

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05051839

Enrollment

Registered

2021-09-21

Start date

2017-06-15

Completion date

2020-12-15

Last updated

2021-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Implant-Abutment Design

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.

Interventions

PROCEDUREImplant surgery and restoration

Implants with two different transmucosal neck configuration are placed.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026