Evaluation of B+ Surface on Early Loading

Not Applicable

Completed

• Conditions: Jaw, Edentulous, Partially
• Interventions: Procedure: Conventional Loading; Procedure: Early Loading

• Registration Number: NCT03059108
• Lead Sponsor: Universidad de Granada

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-02-12
• Study First Submitted QC: 2017-02-15
• Study Start: 2017-02-20
• Study First Posted: 2017-02-23
• Primary Completion: 2020-04-14
• Study Completion: 2020-04-14
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-20
• Last Update Posted: 2023-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional Loading	Conventional Loading	Implant conventional loading: prosthesis delivery 8 weeks after implant placement
Early Loading	Early Loading	Implant early loading: prosthesis delivery 4 weeks after implant placement

Primary Outcome Measures

Name	Time	Method
Clinical success of B+-treated dental implants after conventional or early loading protocol as described by the International Congress of Oral Implantologists, Pisa Consensus Conference, 2007	12 months

Secondary Outcome Measures

Name	Time	Method
Change in marginal bone level around B+-treated implants after conventional or early loading protocol	0 (Baseline: prosthesis delivery), 3, 6, and 12 months
Change in the microbiological profile around B+-treated implants after conventional or early loading protocol	-14 (before impressions), 0 (Baseline: prosthesis delivery), 7 days and 1, 3, 6, 12 months
Change in inflammatory markers in peri-implant crevicular fluid around B+-treated implants after conventional or early loading protocol	-14, 0 (Baseline: prosthesis delivery), 7 days and 1, 3, 6, 12 months

Trial Locations

Locations (1)

Facultad de Odontología; 🇪🇸 Granada, Spain