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CompletedNCT03705247Updated Mar 31, 2023

The Role of Bleeding at Implant Placement

An observational study in Bleeding, Angiogenesis and Peri-Implantitis, sponsored by Universitaire Ziekenhuizen KU Leuven. Completed at 1 site in Belgium. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-31.

Sponsored by Universitaire Ziekenhuizen KU Leuven · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
102
Ages
18 Years to 80 Years
Sex
All
01

Study summary

Angiogenesis is inherently associated to bone formation and healing. During implant osseointegration, a successive and successful angiogenic processes has to occur to promote bone formation. In 1969, Branemark et al. demonstrated that direct contact between bone and titanium implant surface was possible, defining osseointegration as "the direct, structural, and functional contact between live bone and the surface of a functionally loaded implant". Consequently, the need of an empirical measurement appeared. With the introduction of resonance frequency analysis (RFA), it is now possible to measure the degree of implant stability at any time during the course of implant treatment and loading. In this way, changes in implant stability can be monitored over the time and it is likely possible to find implants at risk of failure before they become loose. The rationale of this study is to analyse how important a good vascularization is for the future bone formation around dental implants.

02

Conditions studied

  • Bleeding
  • Angiogenesis
  • Peri-Implantitis

Keywords

  • Dental Implants
03

In context

Peri-Implantitis

304 studies on the registry are indexed under Peri-Implantitis; 84 are open to participants now.

This study's enrollment of 102 is above the median of 80 across 116 observational studies indexed under Peri-Implantitis.

Browse Peri-Implantitis studies →

Lead sponsor

Universitaire Ziekenhuizen KU Leuven is the lead sponsor of 928 studies on the registry; 261 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

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

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Patients who come to the Unit of Periodontology (UZ Leuven, St. Rafaël), in need of implant rehabilitation, will be evaluated for initial study eligibility during a screening visit. Patients shall be advised of the need to attend follow-up visits: 3 months after implant placement (at abutment placement visit) and 1 year, the latter to analyse the early bone remodelling.

Inclusion criteria

  • Males or females American Society of Anesthesiologists classification (ASA) I or II, between 18 to 80 years of age
  • Patient in good general health as documented by self-assessment.
  • Patients needing implant rehabilitation in the upper or lower jaw.
  • Patients must be committed to the study and must be willing to sign the informed consent.

Exclusion criteria

Exclusion Criteria:

  • Any systemic medical condition that could interfere with the surgical procedure or planned treatment.
  • Immunosuppression, Diabetes, Anticoagulation or Antiaggregatory medication.
  • Current pregnancy or breast feeding/ lactating at the time of recruitment.
  • Radiotherapy or Chemotherapy in head and neck area.
  • Intravenous and oral bisphosphonate therapy.
  • Patients smoking >20 cigarettes a day.
  • Unwillingness to return for the follow-up examination.
  • Conditions or circumstances, in the opinion of the investigator, which could represent a general contra-indication for surgical procedure or would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance, or unrealistic expectations.

Local exclusion criteria:

  • Immediate implant placement after tooth extraction.
  • Risk of extra bleeding due to inflammatory or infectious processes near the zone of implantation.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
102 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Correlation between bleeding during implant placement and marginal bone loss

    Peri-implant bone loss after 1 year from the implant placement

    Time frame: 1 year

Secondary outcomes

  1. Correlation between bleeding during implant placement and implant stability quotient (ISQ) values

    Correlation between bleeding during implant placement and implant stability quotient (ISQ) values

    Time frame: 3 months

07

Study locations

1 site
  • UZ Leuven
    Leuven, 3000, Belgium
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 31, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03705247
Lead sponsor
Universitaire Ziekenhuizen KU Leuven
Responsible party
Sponsor
First posted
Oct 15, 2018
Start date
Oct 1, 2018
Primary completion
Oct 1, 2020
Completion
Jan 4, 2021
Last update
Mar 31, 2023

Oversight

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 Oct 2018. You cannot join it, but the record below documents what was studied.

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