Skip to content

The Role of Bleeding at Implant Placement

The Role of Bleeding at Implant Placement: a Prospective Observational Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03705247
Enrollment
102
Registered
2018-10-15
Start date
2018-10-01
Completion date
2021-01-04
Last updated
2023-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Angiogenesis, Bleeding, Peri-Implantitis

Keywords

Dental Implants

Brief 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.

Interventions

None listed

Sponsors

Universitaire Ziekenhuizen KU Leuven
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

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

* 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

Design outcomes

Primary

MeasureTime frameDescription
Correlation between bleeding during implant placement and marginal bone loss1 yearPeri-implant bone loss after 1 year from the implant placement

Secondary

MeasureTime frameDescription
Correlation between bleeding during implant placement and implant stability quotient (ISQ) values3 monthsCorrelation between bleeding during implant placement and implant stability quotient (ISQ) values

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026