Clinical Performance of Dentals Implants With Hydrophilic or Hydrophobic Surfaces

Clinical Performance of Dental Implants With Hydrophilic or Hydrophobic Surfaces in Single Posterior Edentulous Spaces: a Randomized Clinical Trial

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 Overview

• Status: Active, not recruiting
• Conditions: Tooth Loss
• Intervention / Treatment: Device: Hydrophilic surface implants; Device: Hydrophobic surface implants

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Claudio R Leles, PhD; Phone Number: +55 062 32906052; Email: claudio_leles@ufg.br
• Study Contact Backup: Name: Ana Ferreira, MsC; Email: caru_moraes@hotmail.com

Study Locations

• Brazil
  • Goias
    • Goiania, Goias, Brazil
      • Faculty of Dentistry of the Federal University of Goias

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hydrophilic surface implants	Device: 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.; Other Names: Neodent Helix Grand Morse® Acqua
Active Comparator: Hydrophobic surface implants	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.; Other Names: Neodent Helix Grand Morse® Neoporos

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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'.	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.	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.	15-days, 6- and 12-month follow-up visits after delivery of the definitive prosthesis.

Collaborators and Investigators

• Sponsor: Universidade Federal de Goias

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Anticipated): September 11, 2023
• Study Completion (Anticipated): December 30, 2023

Study Registration Dates

• First Submitted: October 15, 2020
• First Submitted That Met QC Criteria: October 24, 2020
• First Posted (Actual): October 27, 2020

Study Record Updates

• Last Update Posted (Actual): May 10, 2023
• Last Update Submitted That Met QC Criteria: May 8, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: single tooth gap; missing tooth
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Tooth Diseases; Tooth Loss
• Other Study ID Numbers: PI04791-2020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No