Clinical Performance of Dentals Implants With Hydrophilic or Hydrophobic Surfaces

NCT04605016 | Unknown

• 1 other identifier: PI04791-2020
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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

Keywords

single tooth gap; missing tooth

Outcome Measures

Primary Outcomes (1)

• 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).

  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 (3)

• Implant success

  Assessed at the 12-month follow-up visit.

• Periimplant bone level

  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

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

Study Arms (2)

Hydrophilic surface implants

EXPERIMENTAL

Device: Hydrophilic surface implants

Hydrophobic surface implants

ACTIVE COMPARATOR

Device: Hydrophobic surface implants

Interventions

Hydrophilic surface implants 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.

Also known as: Neodent Helix Grand Morse® Acqua

Hydrophilic surface implants

Hydrophobic surface implants 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.

Also known as: Neodent Helix Grand Morse® Neoporos

Hydrophobic surface implants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Federal de Goias: lead

Study Sites (1)

Faculty of Dentistry of the Federal University of Goias

Goiânia, Goiás, Brazil

Location

MeSH Terms

Conditions

Tooth Loss; Anodontia

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Tooth Diseases; Tooth Abnormalities; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: October 15, 2020
• First Posted: October 27, 2020
• Study Start: April 1, 2021
• Primary Completion: September 11, 2023
• Study Completion: December 30, 2023
• Last Updated: May 10, 2023

Record last verified: 2023-05

Locations

BR (1)