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Evaluation of B+ Surface on Early Loading

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ClinicalTrials.gov Identifier: NCT03059108
Recruitment Status : Recruiting
First Posted : February 23, 2017
Last Update Posted : May 11, 2018
Sponsor:
Information provided by (Responsible Party):
Pablo Galindo-Moreno, 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.

Condition or disease Intervention/treatment Phase
Jaw, Edentulous, Partially Procedure: Early Loading Procedure: Conventional Loading Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of B+ Surface on Early Loading
Actual Study Start Date : February 20, 2017
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

Arm Intervention/treatment
Experimental: Early Loading
Implant early loading: prosthesis delivery 4 weeks after implant placement
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.

Active Comparator: Conventional Loading
Implant conventional loading: prosthesis delivery 8 weeks after implant placement
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.




Primary Outcome Measures :
  1. 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 [ Time Frame: 12 months ]

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


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03059108


Contacts
Contact: Miguel Padial-Molina, DDS, PhD +34958249032 mipadial@ugr.es

Locations
Spain
Facultad de Odontología Recruiting
Granada, Spain, 18071
Contact: Miguel Padial-Molina, DDS, PhD       mipadial@ugr.es   
Principal Investigator: Pablo Galindo-Moreno, DDS, PhD         
Sub-Investigator: Miguel Padial-Molina, DDS, PhD         
Sponsors and Collaborators
Universidad de Granada
Investigators
Principal Investigator: Pablo Galindo-Moreno, DDS, PhD Universidad de Granada

Responsible Party: Pablo Galindo-Moreno, Professor, Universidad de Granada
ClinicalTrials.gov Identifier: NCT03059108     History of Changes
Other Study ID Numbers: 216CEIH2016
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: May 11, 2018
Last Verified: May 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Jaw, Edentulous
Jaw, Edentulous, Partially
Jaw Diseases
Musculoskeletal Diseases
Stomatognathic Diseases
Mouth, Edentulous
Mouth Diseases
Tooth Diseases