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Clinical Performance of Dentals Implants With Hydrophilic or Hydrophobic Surfaces

U

Universidade Federal de Goias

Status

Active, not recruiting

Conditions

Tooth Loss

Treatments

Device: Hydrophilic surface implants
Device: Hydrophobic surface implants

Study type

Interventional

Funder types

Other

Identifiers

NCT04605016
PI04791-2020

Details and patient eligibility

About

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.

Enrollment

44 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

44 participants in 2 patient groups

Hydrophilic surface implants
Experimental group
Treatment:
Device: Hydrophilic surface implants
Hydrophobic surface implants
Active Comparator group
Treatment:
Device: Hydrophobic surface implants

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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