Clinical trial NCT03059108: Evaluation of B+ Surface on Early Loading
Official title: Evaluation of B+ Surface on Early Loading
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Jaw, Edentulous, Partially
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2017-02-23
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: 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
timeFrame: 12 months
Secondary outcomes:
measure: Change in marginal bone level around B+-treated implants after conventional or early loading protocol
timeFrame: 0 (Baseline: prosthesis delivery), 3, 6, and 12 months
measure: Change in inflammatory markers in peri-implant crevicular fluid around B+-treated implants after conventional or early loading protocol
timeFrame: -14, 0 (Baseline: prosthesis delivery), 7 days and 1, 3, 6, 12 months
measure: Change in the microbiological profile around B+-treated implants after conventional or early loading protocol
timeFrame: -14 (before impressions), 0 (Baseline: prosthesis delivery), 7 days and 1, 3, 6, 12 months
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Facultad de Odontología
Study officials:
affiliation: Universidad de Granada
name: Pablo Galindo-Moreno, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.