Evaluation of B+ Surface on Early Loading

Jaw, Edentulous, Partially Clinical Trial

Official title:

Evaluation of B+ Surface on Early Loading

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03059108
• Other study ID #: 216CEIH2016
• Status: Completed
• Phase: N/A
• Start date: February 20, 2017
• Est. completion date: April 14, 2020

Study information

• Verified date: May 2023
• Source: Universidad de Granada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: April 14, 2020
• Est. primary completion date: April 14, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Jaw, Edentulous
• Jaw, Edentulous, Partially

Intervention

Procedure:
• 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.
• 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.

Locations

Country	Name	City	State
Spain	Facultad de Odontología	Granada

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Granada

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Galindo-Moreno P, Gutierrez-Garrido L, Lopez-Chaichio L, Guerra-Lorenzo C, Rodriguez-Alvarez R, Padial-Molina M. Crestal bone changes around early vs. conventionally loaded implants with a multi-phosphonate coated surface: A randomized pilot clinical tria — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in marginal bone level around B+-treated implants after conventional or early loading protocol		0 (Baseline: prosthesis delivery), 3, 6, and 12 months
Secondary	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
Secondary	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