InflammationNCT05706675
Specialized Pro-resolving Mediators (SPM) as Biomarkers of Periodontal Inflammation
A study testing Non surgical periodontal therapy in people with Inflammation and Periodontitis, run by University of Sharjah at 1 site in United Arab Emirates.
Trial summary
Periodontal diseases are a public health burden in all countries. Hence, Periodontitis is the sixth-most prevalent disease in the world, the most common bone diseases in human and the primary cause for tooth loss in adults leading to significant economic and medical consequences. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammation, Periodontitis
- What is being tested?
- Non surgical periodontal therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 1 Oct 2022to Jun 2024
- Phase
- Interventional
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Control group : Patients diagnosed as periodontally healthy
- Test group:
- Patients diagnosed with generalized periodontitis (Stage 3/4, Grade a,b or c).
- Having at least 15 remaining teeth.
- Mentally able to understand the communication and to express an informed consent
Who cannot join
- Systemic diseases with known effect on periodontal health
- Antibiotics/Anti-inflammatory drugs taken in the last month
- Women with suspected/known pregnancy, or taking any hormone-based treatment
- Patients suffering from Xerostomia.
- Patients smoking more than 20 cig/day.
- Previous periodontal therapy in the last 3-6 months
Trial locations and contacts
1 site in 1 country.
United Arab Emirates1 site, 1 recruiting
- Recruiting
University Dental Hospital Sharjah
Sharjah city
Zahi BADRAN, zbadran@sharjah.ac.ae
About this study
Periodontal diseases are a public health burden in all countries. Hence, Periodontitis is the sixth-most prevalent disease in the world, the most common bone diseases in human and the primary cause for tooth loss in adults leading to significant economic and medical consequences. All disease biomarkers could help to stratify the general population with those at high risk of periodontitis and to enroll them in a rigorous prevention program. Advanced periodontitis has been shown to reduce the quality of life of patients and developing novel biological monitoring protocols will reduce the prevalence of advanced forms of the disease.
There are alot of research explaining the different types of inflammatory mediators that could be found in periodontitis patients. But there are a few research have been talking about lipoxin A4 as an inflammatory biomarker that could detect the effect of non surgical periodontal therapy effect on the periodontal health.
And the aim of the study is to assess the effect of this non surgical periodontal therapy on the periodontal health by assessing the concentration of this biomarker.
- Conditions
- Inflammation, Periodontitis
- Being tested
- Non surgical periodontal therapy
- Medical subject headings
- Inflammation, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non surgical periodontal therapyProcedure or surgery
Manual root planning+Ultrasonic subgingival debridement
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Periodontitis patients that will be treatyed with Non surgical Periodontal Therapy Receives: Procedure: Non surgical periodontal therapy |
| Control | No intervention | Periodontally healthy patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lipoxin A4
Gingival crevicular fluid concentration
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2023
- Study start1 Oct 2022
- Primary completionOct 2023 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InflammationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sharjah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zahi BADRAN, University of Sharjah
- Investigators
- Prof. Zahi Badran, Phd, Study director, University of Sharjah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05706675
- Sponsor's protocol ID
- REC-22-02-28-02-S
- Status last verified
- Jan 2023
- First submitted
- 21 Jan 2023
- Last updated
- 31 Jan 2023
- Results posted
- 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 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Specialized Pro-resolving Mediators (SPM) as Biomarkers of Periodontal Inflammation
- ClinicalTrials.gov ID
- NCT05706675
- Acronym / sponsor ID
- REC-22-02-28-02-S
- Conditions
- Inflammation, Periodontitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of SharjahUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 31 Jan 2023 (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.
Periodontal diseases are a public health burden in all countries. Hence, Periodontitis is the sixth-most prevalent disease in the world, the most common bone diseases in human and the primary cause for tooth loss in adults leading to significant economic and medical consequences. All disease biomarkers could help to stratify the general population with those at high risk of periodontitis and to enroll them in a rigorous prevention program. Advanced periodontitis has been shown to reduce the quality of life of patients and developing novel biological monitoring protocols will reduce the prevalence of advanced forms of the disease.
There are alot of research explaining the different types of inflammatory mediators that could be found in periodontitis patients. But there are a few research have been talking about lipoxin A4 as an inflammatory biomarker that could detect the effect of non surgical periodontal therapy effect on the periodontal health.
And the aim of the study is to assess the effect of this non surgical periodontal therapy on the periodontal health by assessing the concentration of this biomarker.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Procedure: Non surgical periodontal therapyPeriodontitis patients that will be treatyed with Non surgical Periodontal Therapy |
| Control | No intervention | –Periodontally healthy patients |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Control group : Patients diagnosed as periodontally healthy
- Test group:
Key exclusion criteria (6 listed)
- Systemic diseases with known effect on periodontal health
- Antibiotics/Anti-inflammatory drugs taken in the last month
- Women with suspected/known pregnancy, or taking any hormone-based treatment
- Patients suffering from Xerostomia.
- Patients smoking more than 20 cig/day.
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 |
|---|---|---|
| Non surgical periodontal therapyManual root planning+Ultrasonic subgingival debridement | Procedure or surgery | Experimental |
Primary outcome
Lipoxin A4
Time frame: 2 months
Gingival crevicular fluid concentration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2023.
- 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.
Prof. Zahi Badran, Phd study director
University of Sharjah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non surgical periodontal therapy in people with Inflammation and Periodontitis, run by University of Sharjah at 1 site in United Arab Emirates.
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 5 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 31 Jan 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 United Arab Emirates. 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 Prof. Zahi BADRAN, PhD (+97165057353, zbadran@sharjah.ac.ae), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lipoxin A4 (time frame: 2 months). 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 Jan 2023.