Dental ImplantsNCT03513627
Microvascular Reactivity of the Gingiva Around Implant Born Crown
An observational study of Dental Implants, run by Semmelweis University at 1 site in Hungary.
Trial summary
Apply LSCI method for follow-up changes in regional blood flow after compression of the gingiva in order to compare the vascular reactivity of the attached gingiva at implant versus at tooth. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Implants
- What is being tested?
- Post-occlusive reactive hyperemia test (PORH test)
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteHungary
- Study dates
- 28 May 2018to Apr 2020
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy patients who are not taking medication, with healthy gingiva
Who may be able to join
- Patient with single dental implant installed in the front region of the jaw at least 6 months ago. On the contralateral side a natural tooth is located.
Who cannot join
- systemic disease
- smoking
- alcohol abuse
- pregnancy
- gingivitis
- periodontitis
Trial locations and contacts
1 site in 1 country.
Hungary1 site, 1 recruiting
- Recruiting
Janos Vag
Budapest, 1088
Janos Vag, +36209577245, drvagjanos@gmail.com
About this study
Official title: Comparison of Microvascular Reactivity Assessed by Post-occlusive Reactive Hyperaemia Test in Gingiva at Natural Tooth and at Implant Borne Crown
Apply LSCI method for follow-up changes in regional blood flow after compression of the gingiva in order to compare the vascular reactivity of the attached gingiva at implant versus at tooth.
Read the detailed description
This study will examine the effects of implantation and peri-implant soft tissue shaping on the circulation and the regeneration processes of the human gingiva.
The primary aim is to determine the effect of a short term disruption of the blood flow in the gingiva next to an implant and the contralateral tooth, in order to compare the functionally active collateral circulation in the attached gingiva at these respective regions. Using Laser Speckle Contrast Imaging technique (LSCI), which provides blood perfusion data, the investigators will have the possibility to detect functional alterations in gingival microcirculation during and after a short term compression of the gingiva. The secondary aim is to assess and compare the time course of the restoration of the circulation on the affected areas. Further aims are to observe if the compensation capability of the circulation is influenced by gingival thickness (biotype) and patient's gender.
- Conditions
- Dental Implants
- Being tested
- Post-occlusive reactive hyperemia test (PORH test)
- Keywords
- periimplant soft tissue, gingiva, human, microcirculation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Post-occlusive reactive hyperemia test (PORH test)Procedure or surgery
Compression is applied on the buccal side of the attached gingiva, perpendicular to the long axis of the natural or implant born crown 2 mm far from the gingival margin.
| Study group | Role | What they receive |
|---|---|---|
| Implant | Post-occlusive reactive hyperaemia test (PORH test) in the gingiva at a dental implant born crown in the front region of the jaw Receives: Procedure: Post-occlusive reactive hyperemia test (PORH test) | |
| Tooth | Post-occlusive reactive hyperaemia test (PORH test) in the gingiva at the contralateral natural tooth Receives: Procedure: Post-occlusive reactive hyperemia test (PORH test) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Magnitude of the hyperemia after PORH test
Blood flow changes are measured by LSCI before (baseline), during and after gingiva compression. The scale is an arbitrary unit (0-3000 LSPU); relative changes to the baseline measurement will be calculate.
Measured: 5min
Secondary outcomes (3)
Longevity of the hyperemia after PORH test
Blood flow changes are measured by LSCI before (baseline), during and after gingiva compression. The scale is an arbitrary unit (0-3000 LSPU); relative changes to the baseline measurement will be calculate.
Measured: 20min
Size of the hyperemia after PORH test
Blood flow changes are measured by LSCI before (baseline), during and after gingiva compression. LSCI can measure in several cm2 areas and display blood perfusion as color-coded images.
Measured: 20 min
Difference in the magnitude and longevity of hyperemia induced by PORH test next to an implant born crown between women and men.
Blood flow changes are measured by LSCI before (baseline), during and after gingiva compression. The scale is an arbitrary unit (0-3000 LSPU); relative changes to the baseline measurement will be calculate.
Measured: 20 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2018
- Study start28 May 2018
- Primary completionDec 2019 (estimated)
- Study completionApr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental ImplantsStudies of the same condition, open and under way.
- More trials run by Semmelweis UniversityThe 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Semmelweis University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03513627
- Sponsor's protocol ID
- 4/2018
- Status last verified
- Oct 2019
- First submitted
- 19 Apr 2018
- Last updated
- 30 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Microvascular Reactivity Assessed by Post-occlusive Reactive Hyperaemia Test in Gingiva at Natural Tooth and at Implant Borne Crown
- ClinicalTrials.gov ID
- NCT03513627
- Acronym / sponsor ID
- 4/2018
- Conditions
- Dental Implants
- Keywords
- periimplant soft tissue, gingiva, human, microcirculation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Semmelweis UniversityUniversity, hospital or other
- Study start
- 28 May 2018 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Apr 2020 (estimated)
- First posted
- 1 May 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.
Apply LSCI method for follow-up changes in regional blood flow after compression of the gingiva in order to compare the vascular reactivity of the attached gingiva at implant versus at tooth.
Detailed description
This study will examine the effects of implantation and peri-implant soft tissue shaping on the circulation and the regeneration processes of the human gingiva.
The primary aim is to determine the effect of a short term disruption of the blood flow in the gingiva next to an implant and the contralateral tooth, in order to compare the functionally active collateral circulation in the attached gingiva at these respective regions. Using Laser Speckle Contrast Imaging technique (LSCI), which provides blood perfusion data, the investigators will have the possibility to detect functional alterations in gingival microcirculation during and after a short term compression of the gingiva. The secondary aim is to assess and compare the time course of the restoration of the circulation on the affected areas. Further aims are to observe if the compensation capability of the circulation is influenced by gingival thickness (biotype) and patient's gender.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Implant | – | Procedure: Post-occlusive reactive hyperemia test (PORH test)Post-occlusive reactive hyperaemia test (PORH test) in the gingiva at a dental implant born crown in the front region of the jaw |
| Tooth | – | Procedure: Post-occlusive reactive hyperemia test (PORH test)Post-occlusive reactive hyperaemia test (PORH test) in the gingiva at the contralateral natural tooth |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy patients who are not taking medication, with healthy gingiva
Key inclusion criteria (1 listed)
- Patient with single dental implant installed in the front region of the jaw at least 6 months ago. On the contralateral side a natural tooth is located.
Key exclusion criteria (6 listed)
- systemic disease
- smoking
- alcohol abuse
- pregnancy
- gingivitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Post-occlusive reactive hyperemia test (PORH test)Compression is applied on the buccal side of the attached gingiva, perpendicular to the long axis of the natural or implant born crown 2 mm far from the gingival margin. | Procedure or surgery | Implant, Tooth |
Primary outcome
Magnitude of the hyperemia after PORH test
Time frame: 5min
Blood flow changes are measured by LSCI before (baseline), during and after gingiva compression. The scale is an arbitrary unit (0-3000 LSPU); relative changes to the baseline measurement will be calculate.
3 secondary outcomes
Longevity of the hyperemia after PORH test
Time frame: 20min
Size of the hyperemia after PORH test
Time frame: 20 min
Difference in the magnitude and longevity of hyperemia induced by PORH test next to an implant born crown between women and men.
Time frame: 20 min
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2019.
- Individual participant dataSharing planned: No
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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.
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 Dental Implants, run by Semmelweis University at 1 site in Hungary.
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 1 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 30 Oct 2019. 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 Hungary. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Réka Fazekas (+36 203514527, fazekas@medaker.hu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Magnitude of the hyperemia after PORH test (time frame: 5min). 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 30 Oct 2019.