Clinical Performance of Dentals Implants With Hydrophilic or Hydrophobic Surfaces

NCT ID: NCT04605016

Last Updated: 2023-05-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-01
• Study Completion Date: 2023-12-30

Brief Summary

The aim of the study is to compare longitudinally the clinical performance of dental implants with different surfaces placed in single tooth gaps at the posterior maxilla and mandible of adults. It is a randomized clinical trial, in which participants will be randomly allocated to two groups: test group (implants with hydrophilic surface) and control group (implants with hydrophobic surface). The null hypothesis is that the implant stability quotient of hydrophilic and hydrophobic dental implants show a similar progression after placement in posterior tooth gaps.

Conditions

Tooth Loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Hydrophilic surface implants

Group Type: EXPERIMENTAL

Hydrophilic surface implants

Intervention Type: DEVICE

A dental implant with hydrophilic surface will be placed and restored in single-tooh gaps of the posterior region of the mandible or maxilla.

Hydrophobic surface implants

Group Type: ACTIVE_COMPARATOR

Hydrophobic surface implants

Intervention Type: DEVICE

A dental implant with hydrophobic surface will be placed and restored in single-tooh gaps of the posterior region of the mandible or maxilla.

Interventions

Hydrophilic surface implants

A dental implant with hydrophilic surface will be placed and restored in single-tooh gaps of the posterior region of the mandible or maxilla.

Intervention Type: DEVICE

Hydrophobic surface implants

A dental implant with hydrophobic surface will be placed and restored in single-tooh gaps of the posterior region of the mandible or maxilla.

Intervention Type: DEVICE

Other Intervention Names

Neodent Helix Grand Morse® Acqua; Neodent Helix Grand Morse® Neoporos

Eligibility Criteria

Inclusion Criteria

• Present single or multiple intercalated untreated tooth gaps in the posterior region of the mandible or maxilla;
• Agree to participate in the study by signing the informed consent form.

Exclusion Criteria

• Unavailability for participation or signs that they could not comply with the schedule of follow-up visits;
• Presence of general and/or local contraindications that could prevent the surgical procedure for implant placement;
• Presence of conditions that may interfere with the prognosis, such as current treatment with bisphosphonates or report of use for less than 2 years, presence of rheumatic diseases, among others;
• Absence of the minimum bone quantity of 8 mm in length and 3.75 mm in diameter for installation of an implant in the tooth gap;
• Absence of a mesio-distal space of at least 4.6 mm in the single tooth gap required to place the surgical guide;
• Do not present a mouth opening of at least 12mm required for the proper of the guided surgical kit together with the surgical guide;
• Do not present a band of keratinized tissue favorable for maintaining peri-implant health.
• Present motor difficulties that compromise adequate oral hygiene.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidade Federal de Goias

OTHER

Sponsor Role: lead

Responsible Party

Cláudio Rodrigues Leles

Full Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Dentistry of the Federal University of Goias

Goiânia, Goiás, Brazil

Countries

Brazil

Other Identifiers

PI04791-2020

Identifier Type: -

Identifier Source: org_study_id