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Influence of Abutment Shape on Peri-implant Marginal Bone Loss

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ClinicalTrials.gov Identifier: NCT03888339
Recruitment Status : Recruiting
First Posted : March 25, 2019
Last Update Posted : March 25, 2019
Sponsor:
Information provided by (Responsible Party):
David Peñarrocha Oltra, University of Valencia

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Dental Implant Bone Resorption Procedure: Commercially available high abutments placement Procedure: Modified shape abutments Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Influence of Different Abutment Shape on Peri-implant Marginal Bone Loss: A Randomized Clinical Trial.
Actual Study Start Date : November 5, 2018
Estimated Primary Completion Date : December 9, 2020
Estimated Study Completion Date : June 15, 2021

Arm Intervention/treatment
Active Comparator: Control group - Commercially available high abutments
Commercially available 2.5mm high abutments
Procedure: Commercially available high abutments placement
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.

Experimental: Test group - Modified shape abutments
Modified shape 2.5mm high abutments (imitating the shape of 0.5mm short abutments)
Procedure: Modified shape abutments
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 Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03888339


Contacts
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Contact: David Peñarrocha Oltra 649952560 david.penarrocha@uv.es

Locations
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Spain
Clínica Odontológica de la Universitat de Valencia, Fundación Lluis Alcanyis Recruiting
Valencia, Spain, 46010
Contact: David Peñarrocha Oltra    649952560    david.penarrocha@uv.es   
Sponsors and Collaborators
University of Valencia

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Responsible Party: David Peñarrocha Oltra, Assistanat Postdoctoral Lecturer (Profesor Ayudante Doctor), University of Valencia
ClinicalTrials.gov Identifier: NCT03888339     History of Changes
Other Study ID Numbers: H1524219380739
First Posted: March 25, 2019    Key Record Dates
Last Update Posted: March 25, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Bone Resorption
Bone Diseases
Musculoskeletal Diseases