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Completed

NCT Number: NCT05051839

Validation Use of Implants and Abutments With Biologically Oriented Preparation Technique

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.

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Key information

Conditions

Dental Implant-Abutment Design

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Unviersidad Complutense de Madrid

Madrid, 28040, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Implant surgery and restoration

Procedure

Implants with two different transmucosal neck configuration are placed.

Primary outcomes

  1. Marginal bone level

    Time frame: Baseline to 12-months follow-up

    Changes in interproximal marginal bone level with standardization of the radiograph

  2. Soft tissue volumetric analysis

    Time frame: Baseline to 12-motnhs follow-up

    Soft tissue volumetric analysis with digital impressiones taken at baseline and at 12-month follow-up visit

Sponsors and collaborators

Lead sponsor

Universidad Complutense de Madrid

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Sep 21, 2021
Registry last updated
Sep 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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