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Clinical Performance of Dentals Implants With Hydrophilic or Hydrophobic Surfaces

Primary Purpose

Tooth Loss

Status
Active
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Hydrophilic surface implants
Hydrophobic surface implants
Sponsored by
Universidade Federal de Goias
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tooth Loss focused on measuring single tooth gap, missing tooth

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Faculty of Dentistry of the Federal University of Goias

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Hydrophilic surface implants

Hydrophobic surface implants

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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

Full Information

First Posted
October 15, 2020
Last Updated
May 8, 2023
Sponsor
Universidade Federal de Goias
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1. Study Identification

Unique Protocol Identification Number
NCT04605016
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
September 11, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal de Goias

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth Loss
Keywords
single tooth gap, missing tooth

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hydrophilic surface implants
Arm Type
Experimental
Arm Title
Hydrophobic surface implants
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Hydrophilic surface implants
Other Intervention Name(s)
Neodent Helix Grand Morse® Acqua
Intervention Description
A dental implant with hydrophilic surface will be placed and restored in single-tooh gaps of the posterior region of the mandible or maxilla.
Intervention Type
Device
Intervention Name(s)
Hydrophobic surface implants
Other Intervention Name(s)
Neodent Helix Grand Morse® Neoporos
Intervention Description
A dental implant with hydrophobic surface will be placed and restored in single-tooh gaps of the posterior region of the mandible or maxilla.
Primary Outcome Measure Information:
Title
Change of implant stability
Description
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 Outcome Measure Information:
Title
Implant success
Description
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.
Title
Periimplant bone level
Description
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.
Title
Condition of the periimplant soft tissues
Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Faculty of Dentistry of the Federal University of Goias
City
Goiania
State/Province
Goias
Country
Brazil

12. IPD Sharing Statement

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Clinical Performance of Dentals Implants With Hydrophilic or Hydrophobic Surfaces

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