Clinical Performance of Dentals Implants With Hydrophilic or Hydrophobic Surfaces

Universidade Federal de Goias44 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Tooth Loss

Interventions

Hydrophilic surface implantsDEVICE

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 implantsDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Faculty of Dentistry of the Federal University of Goias

Goiânia, Goiás, Brazil

Outcomes

Primary Outcomes

Change of implant stability

Implant stability was set as the primary outcome. The implant stability quotient (ISQ) will be measured using a portable device called Osstell ISQ (Osstell Mentor, Integration Diagnostics, Göteborg, Sweden).

Time frame: 10 time-points will be considered and divided in two phases: surgical and prosthetic. The last measure will occur 1 year after the placement of the definitive implant restoration.

Secondary Outcomes

Implant success

Each implant will be assessed according to the health scale of the International Congress of Oral Implantologists (ICOI-Pisa health scale). After clinical assessment, each implant will be classified as 'success', 'satisfactory survival', 'compromised survival' or 'failure'.

Time frame: Assessed at the 12-month follow-up visit.

Periimplant bone level

Periapical radiographs will be obtained and the periimplant bone level will be measured and compared longitudinally.

Time frame: Radiographs will be obtained at 4 time points: immediately after implant placement, at the session of the provisional prosthesis installation, and at the 6 and 12-month follow-up visits after the delivery of the definitive prosthesis.

Condition of the periimplant soft tissues

The following parameters will be assessed clinically: presence/absence of bleeding on probing, probing depth, and presence/absence suppuration.

Time frame: 15-days, 6- and 12-month follow-up visits after delivery of the definitive prosthesis.

Data from ClinicalTrials.gov

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