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CompletedNCT03059108Updated May 23, 2023

Evaluation of B+ Surface on Early Loading

An interventional study of Early Loading and Conventional Loading in Jaw, Edentulous, Partially, sponsored by Universidad de Granada. Completed at 1 site in Spain. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-23.

Sponsored by Universidad de Granada · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
34
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Jaw, Edentulous, Partially
03

In context

Jaw, Edentulous

171 studies on the registry are indexed under Jaw, Edentulous; 24 are open to participants now.

This study's enrollment of 34 is close to the median of 33 across 146 interventional studies indexed under Jaw, Edentulous.

Browse Jaw, Edentulous studies →

Lead sponsor

Universidad de Granada is the lead sponsor of 241 studies on the registry; 41 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
34 participants (actual)

Study arms

  • Experimental
    Early Loading

    Implant early loading: prosthesis delivery 4 weeks after implant placement

    Procedure: Early Loading

  • Active comparator
    Conventional Loading

    Implant conventional loading: prosthesis delivery 8 weeks after implant placement

    Procedure: Conventional Loading

Interventions

  • ProcedureEarly 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.

  • ProcedureConventional 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.

06

What researchers measure

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

    Time frame: 12 months

Secondary outcomes

  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

07

Study locations

1 site
  • Facultad de Odontología
    Granada, 18071, Spain
08

References and documents

Publications

  • 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. PubMed 33210771 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 23, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03059108
Lead sponsor
Universidad de Granada
Responsible party
Pablo Galindo-Moreno (Professor, Universidad de Granada) — Principal investigator
First posted
Feb 23, 2017
Start date
Feb 20, 2017
Primary completion
Apr 14, 2020
Completion
Apr 14, 2020
Last update
May 23, 2023

Study contacts

Pablo Galindo-Moreno, DDS, PhD
principal investigator · Universidad de Granada

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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