Influence of Abutment Shape on Peri-implant Marginal Bone Loss

Not Applicable

Completed

• Conditions: Dental Implant; Bone Resorption
• Interventions: Procedure: Modified shape abutments; Procedure: Commercially available high abutments placement

• Registration Number: NCT03888339
• Lead Sponsor: 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 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).

Study Timeline

• Study Start: 2018-11-05
• Study First Submitted: 2018-12-11
• Study First Submitted QC: 2019-03-22
• Study First Posted: 2019-03-25
• Primary Completion: 2022-05-31
• Study Completion: 2022-05-31
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-22
• Last Update Posted: 2022-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test group - Modified shape abutments	Modified shape abutments	Modified shape 2.5mm high abutments (imitating the shape of 0.5mm short abutments)
Control group - Commercially available high abutments	Commercially available high abutments placement	Commercially available 2.5mm high abutments

Primary Outcome Measures

Name	Time	Method
Peri-implant bone level changes	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

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

Trial Locations

Locations (1)

Clínica Odontológica de la Universitat de Valencia, Fundación Lluis Alcanyis; 🇪🇸 Valencia, Spain