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NCT Number: NCT03888339

Influence of Abutment Shape on Peri-implant Marginal Bone Loss

A study designed as a randomized controlled trial of parallel group design will be conducted at the Dental clinic of the University of Valencia to evaluate the influence of 2.5 mm high abutments with different shapes (commercially available high abutments vs high abutments with modified shape to imitate short abutments) on peri-implant bone loss around bone level implants with platform switching in partially edentulous patients that require a fixed rehabilitation supported by two implants in the posterior mandible or maxilla and in fixed rehabilitation supported by one implant in the anterior mandible or maxilla.

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Key information

Conditions

Dental Implant Bone Diseases Bone Resorption Musculoskeletal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clínica Odontológica de la Universitat de Valencia, Fundación Lluis Alcanyis

Valencia, 46010, Spain

About this study

A study designed as a randomized controlled trial of parallel group design will be conducted at the Dental clinic of the University of Valencia to evaluate the influence of 2.5 mm high abutments with different shapes (commercially available high abutments vs high abutments with modified shape to imitate short abutments) on peri-implant bone loss around bone level implants with platform switching in partially edentulous patients that require a fixed rehabilitation supported by two implants in the posterior mandible or maxilla and in fixed rehabilitation supported by one implant in the anterior mandible or maxilla (from premolar to premolar).

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Any subject requiring two implants in the posterior mandible or maxilla, being at least 18 years old and able to sign an informed consent. Final patient inclusion will be made after flap elevation during the implant placement surgery to be able to confirm the presence of a vertical thickness ≥ 3mm of keratinized soft tissues.
  • Bone volumes should allow the placement of implants at least 8 mm long (i.e, 10 mm bone height to the inferior alveolar nerve) and 4.2 mm wide (7 mm wide bone crest) without bone regeneration procedures.
  • Patients will be grouped into: 1) non smokers; 2) light smokers (≤ 10 cigarettes/day); 3) heavy smokers (≥ 11 cigarettes/day)

Exclusion criteria

  • Patients unable to commit to follow-up.
  • General contraindications to implant surgery.
  • Immuno-suppressed/immune-compromised patients.
  • Patients irradiated in the head and/or neck.
  • Uncontrolled diabetes.
  • Pregnancy or lactation.
  • Untreated periodontal disease.
  • Poor oral hygiene and motivation.
  • Addiction to alcohol or drugs.
  • Psychiatric problems and/or unrealistic expectations.
  • Patients with an acute infection (abscess) or suppuration in the site intended for implant placement.
  • Patients treated or under treatment with intravenous amino-bisphosphonates.
  • Patients referred only for implant placement if the follow-up cannot be done at the treatment center.
  • Patients participating in other studies, if the present protocol could not be fully adhered to.

Treatment and study plan

Commercially available high abutments placement

Procedure

Patients will be randomly selected for the commercially available high abutments option. Two or three implants will be placed following the drilling protocol suggested by the manufacturer. Implants will be placed 0.5mm subcrestal. Once the implants have been placed, periapical radiographs and clinical pictures will be taken. Implants will be uncovered 10 weeks after being placed. After performing the incision and elevation a minimal flap, conventional high transmucosal abutments will be screwed using the torque recommended by the manufacturer. Once the abutments have been screwed, periapical radiographs and clinical pictures will be taken. The abutments will not be unscrewed thereafter throughout the study.

Modified shape abutments

Procedure

Patients will be randomly selected for the modified shape abutments option. Two or three implants will be placed following the drilling protocol suggested by the manufacturer. Implants will be placed 0.5mm subcrestal. Once the implants have been placed, periapical radiographs and clinical pictures will be taken. Implants will be uncovered 10 weeks after being placed. After performing the incision and elevation a minimal flap, modified high transmucosal abutments will be screwed using the torque recommended by the manufacturer. Once the abutments have been screwed, periapical radiographs and clinical pictures will be taken. The abutments will not be unscrewed thereafter throughout the study.

Primary outcomes

  1. Peri-implant bone level changes

    Time frame: 12 months after implant loading

    Assessed on digital periapical radiographs taken with the paralleling technique at delivery of crowns (implant loading) and 12 months afterwards.

Secondary outcomes

  1. Implant survival rate

    Time frame: 12 months after implant loading

    % of implants in function

  2. Probing pocket depth

    Time frame: 12 months after implant loading

    Measured in millimeters with a millimetered periodontal probe

  3. Bleeding on probing

    Time frame: 12 months after implant loading

    Positive or negative bleeding after having probed with a millimetered periodontal probe

  4. Peri-implant soft tissue recession

    Time frame: 12 months after implant loading

    Measured in millimeters with a millimetered periodontal probe

Sponsors and collaborators

Lead sponsor

University of Valencia

Other

Registry information

Official study title

Influence of Different Abutment Shape on Peri-implant Marginal Bone Loss: A Randomized Clinical Trial.

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Mar 25, 2019
Registry last updated
Jun 24, 2022

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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