Evaluation of B+ Surface on Early Loading

University of Granada (UGR)

Status

Completed

Conditions

Jaw, Edentulous, Partially

Treatments

Procedure: Conventional Loading

Procedure: Early Loading

Study type

Interventional

Funder types

Other

Identifiers

NCT03059108

216CEIH2016

Details and patient eligibility

About

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.

Enrollment

34 patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

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