Influence of Abutment Shape on Peri-implant Marginal Bone Loss

NCT03888339 | Completed

• 1 other identifier: H1524219380739
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Implant; Bone Resorption

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Implant survival rate

  12 months after implant loading

• Probing pocket depth

  12 months after implant loading

• Bleeding on probing

  12 months after implant loading

• Peri-implant soft tissue recession

  12 months after implant loading

Study Arms (2)

Control group - Commercially available high abutments

ACTIVE COMPARATOR

Commercially available 2.5mm high abutments

Procedure: Commercially available high abutments placement

Test group - Modified shape abutments

EXPERIMENTAL

Modified shape 2.5mm high abutments (imitating the shape of 0.5mm short abutments)

Procedure: Modified shape abutments

Interventions

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.

Control group - Commercially available high abutments

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.

Test group - Modified shape abutments

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (1)

Clínica Odontológica de la Universitat de Valencia, Fundación Lluis Alcanyis

Valencia, 46010, Spain

Location

MeSH Terms

Conditions

Bone Resorption

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistanat Postdoctoral Lecturer (Profesor Ayudante Doctor)

Study Record Dates

• First Submitted: December 11, 2018
• First Posted: March 25, 2019
• Study Start: November 5, 2018
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2022
• Last Updated: June 24, 2022

Record last verified: 2022-06

Locations

ES (1)