Evaluation of B+ Surface on Early Loading
1 other identifier
interventional
34
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 12, 2017
CompletedStudy Start
First participant enrolled
February 20, 2017
CompletedFirst Posted
Study publicly available on registry
February 23, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 14, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 14, 2020
CompletedMay 23, 2023
May 1, 2023
3.1 years
February 12, 2017
May 20, 2023
Conditions
Outcome Measures
Primary Outcomes (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
12 months
Secondary Outcomes (3)
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 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
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
Study Arms (2)
Early Loading
EXPERIMENTALImplant early loading: prosthesis delivery 4 weeks after implant placement
Conventional Loading
ACTIVE COMPARATORImplant conventional loading: prosthesis delivery 8 weeks after implant placement
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Patient \>18 and ≤75 years old
- One missing tooth in the premolar or molar area with both opposing and adjacent teeth (mesial and distal).
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Facultad de Odontología
Granada, 18071, Spain
Related Publications (2)
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 trial. Clin Oral Implants Res. 2021 Jan;32(1):75-87. doi: 10.1111/clr.13681. Epub 2020 Dec 18.
PMID: 33210771RESULTGalindo-Moreno P, Gutierrez-Garrido L, Duarte J, Robles-Vera I, Martin-Morales N, O'Valle F, Olaechea A, Carrillo-Galvez AB, Padial-Molina M. Evolution in the Peri-Implant Oral Microbiome and Their Relationship to Long-Term Marginal Bone Loss: A Randomized Clinical Study. Clin Oral Implants Res. 2025 Jul;36(7):802-820. doi: 10.1111/clr.14426. Epub 2025 Mar 10.
PMID: 40062725DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pablo Galindo-Moreno, DDS, PhD
Universidad de Granada
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 12, 2017
First Posted
February 23, 2017
Study Start
February 20, 2017
Primary Completion
April 14, 2020
Study Completion
April 14, 2020
Last Updated
May 23, 2023
Record last verified: 2023-05