The Role of Bleeding at Implant Placement

Bleeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03705247
• Other study ID #: S58575
• Status: Completed
• Start date: October 1, 2018
• Est. completion date: January 4, 2021

Study information

• Verified date: October 2018
• Source: Universitaire Ziekenhuizen KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: January 4, 2021
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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 exclusion criteria:

• Immediate implant placement after tooth extraction.

• Risk of extra bleeding due to inflammatory or infectious processes near the zone of implantation.

Related Conditions & MeSH terms

• Angiogenesis
• Bleeding
• Hemorrhage
• Peri-Implantitis

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between bleeding during implant placement and marginal bone loss	Peri-implant bone loss after 1 year from the implant placement	1 year
Secondary	Correlation between bleeding during implant placement and implant stability quotient (ISQ) values	Correlation between bleeding during implant placement and implant stability quotient (ISQ) values	3 months