Clinical Performance of Dentals Implants With Hydrophilic or Hydrophobic Surfaces

Study Overview
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Brief Summary
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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.

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

Conditions
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Tooth Loss

Intervention / Treatment
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* Device: Hydrophilic surface implants
* Device: Hydrophobic surface implants


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hydrophilic surface implants<br> | Device: Hydrophilic surface implants<br>* A dental implant with hydrophilic surface will be placed and restored in single-tooh gaps of the posterior region of the mandible or maxilla.<br>* Other names: Neodent Helix Grand Morse® Acqua;|
| Active Comparator: Hydrophobic surface implants<br> | Device: Hydrophobic surface implants<br>* A dental implant with hydrophobic surface will be placed and restored in single-tooh gaps of the posterior region of the mandible or maxilla.<br>* Other names: Neodent Helix Grand Morse® Neoporos;|

What is the study measuring?
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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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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single tooth gap, missing tooth