The Role of Bleeding at Implant Placement

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

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.

Study Overview

• Status: Completed
• Conditions: Bleeding; Peri-Implantitis; Angiogenesis

• Study Type: Observational
• Enrollment (Actual): 102

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • UZ Leuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between bleeding during implant placement and marginal bone loss	Peri-implant bone loss after 1 year from the implant placement	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Actual): October 1, 2020
• Study Completion (Actual): January 4, 2021

Study Registration Dates

• First Submitted: October 10, 2018
• First Submitted That Met QC Criteria: October 10, 2018
• First Posted (Actual): October 15, 2018

Study Record Updates

• Last Update Posted (Actual): March 31, 2023
• Last Update Submitted That Met QC Criteria: March 30, 2023
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Dental Implants
• Additional Relevant MeSH Terms: Pathologic Processes; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Hemorrhage; Peri-Implantitis
• Other Study ID Numbers: S58575

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No