Influence of Abutment Shape on Peri-implant Marginal Bone Loss
Primary Purpose
Dental Implant, Bone Resorption
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Commercially available high abutments placement
Modified shape abutments
Sponsored by
About this trial
This is an interventional treatment trial for Dental Implant
Eligibility 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.
Sites / Locations
- Clínica Odontológica de la Universitat de Valencia, Fundación Lluis Alcanyis
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control group - Commercially available high abutments
Test group - Modified shape abutments
Arm Description
Commercially available 2.5mm high abutments
Modified shape 2.5mm high abutments (imitating the shape of 0.5mm short abutments)
Outcomes
Primary Outcome Measures
Peri-implant bone level changes
Assessed on digital periapical radiographs taken with the paralleling technique at delivery of crowns (implant loading) and 12 months afterwards.
Secondary Outcome Measures
Implant survival rate
% of implants in function
Probing pocket depth
Measured in millimeters with a millimetered periodontal probe
Bleeding on probing
Positive or negative bleeding after having probed with a millimetered periodontal probe
Peri-implant soft tissue recession
Measured in millimeters with a millimetered periodontal probe
Full Information
NCT ID
NCT03888339
First Posted
December 11, 2018
Last Updated
June 22, 2022
Sponsor
University of Valencia
1. Study Identification
Unique Protocol Identification Number
NCT03888339
Brief Title
Influence of Abutment Shape on Peri-implant Marginal Bone Loss
Official Title
Influence of Different Abutment Shape on Peri-implant Marginal Bone Loss: A Randomized Clinical Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
November 5, 2018 (Actual)
Primary Completion Date
May 31, 2022 (Actual)
Study Completion Date
May 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Valencia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 and in fixed rehabilitation supported by one implant in the anterior mandible or maxilla.
Detailed Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Implant, Bone Resorption
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group - Commercially available high abutments
Arm Type
Active Comparator
Arm Description
Commercially available 2.5mm high abutments
Arm Title
Test group - Modified shape abutments
Arm Type
Experimental
Arm Description
Modified shape 2.5mm high abutments (imitating the shape of 0.5mm short abutments)
Intervention Type
Procedure
Intervention Name(s)
Commercially available high abutments placement
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Modified shape abutments
Intervention Description
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 Measure Information:
Title
Peri-implant bone level changes
Description
Assessed on digital periapical radiographs taken with the paralleling technique at delivery of crowns (implant loading) and 12 months afterwards.
Time Frame
12 months after implant loading
Secondary Outcome Measure Information:
Title
Implant survival rate
Description
% of implants in function
Time Frame
12 months after implant loading
Title
Probing pocket depth
Description
Measured in millimeters with a millimetered periodontal probe
Time Frame
12 months after implant loading
Title
Bleeding on probing
Description
Positive or negative bleeding after having probed with a millimetered periodontal probe
Time Frame
12 months after implant loading
Title
Peri-implant soft tissue recession
Description
Measured in millimeters with a millimetered periodontal probe
Time Frame
12 months after implant loading
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
Clínica Odontológica de la Universitat de Valencia, Fundación Lluis Alcanyis
City
Valencia
ZIP/Postal Code
46010
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Influence of Abutment Shape on Peri-implant Marginal Bone Loss
We'll reach out to this number within 24 hrs