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OpenTrials
Completed

NCT Number: NCT03705247

The Role of Bleeding at Implant Placement

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.

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Key information

Conditions

Bleeding Angiogenesis Hemorrhage Mouth Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Peri-Implantitis Periodontal Diseases Stomatognathic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

UZ Leuven

Leuven, 3000, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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

    Time frame: 1 year

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

Secondary outcomes

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

    Time frame: 3 months

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

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Oct 15, 2018
Registry last updated
Mar 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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