Clinical trial NCT04605016: Clinical Performance of Dentals Implants With Hydrophilic or Hydrophobic Surfaces
Official title: Clinical Performance of Dental Implants With Hydrophilic or Hydrophobic Surfaces in Single Posterior Edentulous Spaces: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tooth Loss
Keywords: single tooth gap
missing tooth
Lead sponsor: Universidade Federal de Goias
Sponsor class: OTHER
First posted: 2020-10-27
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change of implant stability
timeFrame: 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:
measure: Implant success
timeFrame: Assessed at the 12-month follow-up visit.
measure: Periimplant bone level
timeFrame: 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.
measure: Condition of the periimplant soft tissues
timeFrame: 15-days, 6- and 12-month follow-up visits after delivery of the definitive prosthesis.
Other outcomes:
Locations:
city: Goiania
country: Brazil
facility: Faculty of Dentistry of the Federal University of Goias
state: Goias
Study officials:
References: