Clinical Performance of Dentals Implants With Hydrophilic or Hydrophobic Surfaces

• Sponsor: Universidade Federal de Goias (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04605016
• Collaborator: (none)
• Enrollment: 44
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 28.9
• Patients Per Site Per Month: 1.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Tooth Loss	Device: Hydrophilic surface implants; Device: Hydrophobic surface implants	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 44 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Clinical Performance of Dental Implants With Hydrophilic or Hydrophobic Surfaces in Single Posterior Edentulous Spaces: a Randomized Clinical Trial
• Actual Study Start Date: Apr 1, 2021
• Anticipated Primary Completion Date: May 30, 2023
• Anticipated Study Completion Date: Aug 30, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change of implant stability [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.]

   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

1. Implant success [Assessed at the 12-month follow-up visit.]

   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'.

2. 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.]

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

3. Condition of the periimplant soft tissues [15-days, 6- and 12-month follow-up visits after delivery of the definitive prosthesis.]

   The following parameters will be assessed clinically: presence/absence of bleeding on probing, probing depth, and presence/absence suppuration.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Dentistry of the Federal University of Goias	Goiania	Goias	Brazil

Sponsors and Collaborators

• Universidade Federal de Goias

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Cláudio Rodrigues Leles, Full Professor, Universidade Federal de Goias
• ClinicalTrials.gov Identifier: NCT04605016
• Other Study ID Numbers: PI04791-2020
• First Posted: Oct 27, 2020
• Last Update Posted: Oct 8, 2021
• Last Verified: Oct 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Cláudio Rodrigues Leles, Full Professor, Universidade Federal de Goias: single tooth gap; missing tooth
• Additional relevant MeSH terms: Tooth Loss

Study Results

No Results Posted as of Oct 8, 2021