Peri-ImplantitisNCT05325918
HIF-1 Alpha, VEGF and MMP-8 Levels in PICF of Smokers Versus Non Smokers
An observational study of Peri-Implantitis, run by Future University in Egypt at 1 site in Egypt.
Trial summary
Smoking is a major risk factor for developing peri-implantitis so the current study is comparing inflammatory markers in smokers versus non smokers to know if they have a potential role in pathogenesis of peri-implantitis Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Peri-Implantitis
- How many people
- 14 participants
- Where
- 1 siteEgypt
- Study dates
- 29 Aug 2021to 30 Jan 2022
- 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Smoker patients with restored implants
Who may be able to join
- Medically free patients
- Individuals with restored implants placed one year or more before study enrollment
- Both genders
- Age range 20-50 years old
Who cannot join
- Pregnant Females
- Lactating females
Trial locations and contacts
1 site in 1 country.
About this study
Official title: HIF-1 Alpha, VEGF and MMP-8 Levels in Peri-implant Crevicular Fluid of Smokers Versus Non Smokers
Smoking is a major risk factor for developing peri-implantitis so the current study is comparing inflammatory markers in smokers versus non smokers to know if they have a potential role in pathogenesis of peri-implantitis
Read the detailed description
Peri -implant crevicular fluid was obtained from seven smoker patients and then compared to peri-implant crevicular fluid from seven non smoker individuals.
The peri-implant crevicular fluid was obtained using periopaper strips then analyzed using ELISA kits of these markers; HIF-1 Alpha, VEGF and MMP-8
- Conditions
- Peri-Implantitis
- Keywords
- gingival crevicular fluid, Smoking, inflammation
- Medical subject headings
- Peri-Implantitis, Smoking, Inflammation
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of levels of HIF-1 Alpha, VEGF and MMP-8 in peri-implant crevicular fluid
Markers collected using periopaper strips
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2022
- Study start29 Aug 2021
- Primary completion15 Jan 2022
- Study completion30 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peri-ImplantitisStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Future University in Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Elkot, Future University in Egypt
- Investigators
- Sarah M Elkot, Lecturer, Principal investigator, Lecturer of Oral Medicine and Periodontology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05325918
- Sponsor's protocol ID
- FUE13
- Status last verified
- Apr 2022
- First submitted
- 6 Apr 2022
- Last updated
- 14 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HIF-1 Alpha, VEGF and MMP-8 Levels in Peri-implant Crevicular Fluid of Smokers Versus Non Smokers
- ClinicalTrials.gov ID
- NCT05325918
- Acronym / sponsor ID
- FUE13
- Conditions
- Peri-Implantitis
- Keywords
- gingival crevicular fluid, Smoking, inflammation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Future University in EgyptUniversity, hospital or other
- Study start
- 29 Aug 2021 (actual)
- Primary completion
- 15 Jan 2022 (actual)
- Study completion
- 30 Jan 2022 (actual)
- First posted
- 13 Apr 2022 (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.
Smoking is a major risk factor for developing peri-implantitis so the current study is comparing inflammatory markers in smokers versus non smokers to know if they have a potential role in pathogenesis of peri-implantitis
Detailed description
Peri -implant crevicular fluid was obtained from seven smoker patients and then compared to peri-implant crevicular fluid from seven non smoker individuals.
The peri-implant crevicular fluid was obtained using periopaper strips then analyzed using ELISA kits of these markers; HIF-1 Alpha, VEGF and MMP-8
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Smoker patients with restored implants
Key inclusion criteria (4 listed)
- Medically free patients
- Individuals with restored implants placed one year or more before study enrollment
- Both genders
- Age range 20-50 years old
Key exclusion criteria (2 listed)
- Pregnant Females
- Lactating females
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
Measurement of levels of HIF-1 Alpha, VEGF and MMP-8 in peri-implant crevicular fluid
Time frame: Baseline
Markers collected using periopaper strips
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 14 Apr 2022.
- Individual participant dataSharing planned: Undecided
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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.
Sarah M Elkot, Lecturer principal investigator
Lecturer of Oral Medicine and Periodontology
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 Peri-Implantitis, run by Future University in Egypt at 1 site in Egypt.
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 2 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 14 Apr 2022. 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 Egypt. 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?
Measurement of levels of HIF-1 Alpha, VEGF and MMP-8 in peri-implant crevicular fluid (time frame: Baseline). 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 14 Apr 2022.