BleedingNCT03705247
The Role of Bleeding at Implant Placement
An observational study of Bleeding and Angiogenesis, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Bleeding, Angiogenesis, Peri-Implantitis
- How many people
- 102 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Oct 2018to 4 Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Bleeding, Angiogenesis, Peri-Implantitis
- Keywords
- Dental Implants
- Medical subject headings
- Hemorrhage, Peri-Implantitis
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between bleeding during implant placement and marginal bone loss
Peri-implant bone loss after 1 year from the implant placement
Measured: 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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2018
- Study start1 Oct 2018
- Primary completion1 Oct 2020
- Study completion4 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BleedingStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03705247
- Sponsor's protocol ID
- S58575
- Status last verified
- Oct 2018
- First submitted
- 10 Oct 2018
- Last updated
- 31 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Bleeding at Implant Placement: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT03705247
- Acronym / sponsor ID
- S58575
- Conditions
- Bleeding, Angiogenesis, Peri-Implantitis
- Keywords
- Dental Implants
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 4 Jan 2021 (actual)
- First posted
- 15 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Correlation between bleeding during implant placement and implant stability quotient (ISQ) values
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bleeding and Angiogenesis, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between bleeding during implant placement and marginal bone loss (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2023.