Influence of Abutment Shape on Peri-implant Marginal Bone Loss

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

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.

Study Overview

• Status: Completed
• Conditions: Bone Resorption; Dental Implant
• Intervention / Treatment: Procedure: Commercially available high abutments placement; Procedure: Modified shape abutments

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).

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Valencia, Spain, 46010
    • Clínica Odontológica de la Universitat de Valencia, Fundación Lluis Alcanyis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months after implant loading

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implant survival rate	% of implants in function	12 months after implant loading
Probing pocket depth	Measured in millimeters with a millimetered periodontal probe	12 months after implant loading
Bleeding on probing	Positive or negative bleeding after having probed with a millimetered periodontal probe	12 months after implant loading
Peri-implant soft tissue recession	Measured in millimeters with a millimetered periodontal probe	12 months after implant loading

Collaborators and Investigators

• Sponsor: University of Valencia

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2018
• Primary Completion (Actual): May 31, 2022
• Study Completion (Actual): May 31, 2022

Study Registration Dates

• First Submitted: December 11, 2018
• First Submitted That Met QC Criteria: March 22, 2019
• First Posted (Actual): March 25, 2019

Study Record Updates

• Last Update Posted (Actual): June 24, 2022
• Last Update Submitted That Met QC Criteria: June 22, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Bone Diseases; Bone Resorption
• Other Study ID Numbers: H1524219380739

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No