Evaluation of B+ Surface on Early Loading

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-20

Study Completion Date

2020-04-14

Brief Summary

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The trial is designed as a consecutive enrollment prospective one-center study. A minimum of 30 patients will be included in the study. At implant installation, the implant will be randomized to one of the groups (Control: conventional loading, 8 weeks; Test: early loading, 4 weeks). Samples of peri-implant crevicular fluid (PICF) and intrasulcular plaque will be collected at -14, 0 (Baseline: prosthesis delivery), 7 days and 1, 3, 6, 12 months. Prosthesis will be fabricated and delivered as usual, i.e., approximately two weeks after the impressions are taken.

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Detailed Description

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Conditions

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Jaw, Edentulous, Partially

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Early Loading

Implant early loading: prosthesis delivery 4 weeks after implant placement

Group Type EXPERIMENTAL

Early Loading

Intervention Type PROCEDURE

The procedure in this group will consist on placing implant-supported restorations over the implants placed 4 weeks earlier. The device (dental implant) is of the same type in both groups.

Conventional Loading

Implant conventional loading: prosthesis delivery 8 weeks after implant placement

Group Type ACTIVE_COMPARATOR

Conventional Loading

Intervention Type PROCEDURE

The procedure in this group will consist on placing implant-supported restorations over the implants placed 8 weeks earlier. The device (dental implant) is of the same type in both groups.

Interventions

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Early Loading

The procedure in this group will consist on placing implant-supported restorations over the implants placed 4 weeks earlier. The device (dental implant) is of the same type in both groups.

Intervention Type PROCEDURE

Conventional Loading

The procedure in this group will consist on placing implant-supported restorations over the implants placed 8 weeks earlier. The device (dental implant) is of the same type in both groups.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patient \>18 and ≤75 years old
* One missing tooth in the premolar or molar area with both opposing and adjacent teeth (mesial and distal).

Exclusion Criteria

* One-stage bone augmentation
* Heavy smokers (\>10 cigarettes/day)
* Uncontrolled type 1 or 2 diabetes (HgA1c\>8)
* Known auto-immune or inflammatory disease
* Severe hematologic disorders, such as hemophilia or leukemia
* Local or systemic infection that may compromise normal healing (e.g., extensive periapical pathology)
* Liver or kidney dysfunction/failure
* Currently receiving cancer treatment or within 18 months from completion of radio- or chemotherapy
* Long-term history of oral bisphosphonates use (i.e., 10 years or more)
* History of intravenous bisphosphonates
* Long-term (\>3 months) history of antibiotics or drugs known to alter the inflammation and/or immunological system
* Severe osseous diseases (e.g., Paget disease of bone)
* Pregnant women or nursing mothers
* Not able or not willing to follow instructions related to the study procedures

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes