MenopauseNCT04141033
Assessment of Neopterin Levels in Pre- and Post-menopausal Women With Chronic Periodontitis
A study testing assessment of neopterin levels in people with Menopause, run by Ain Shams University at 1 site in Egypt.
Trial summary
Neopterin is an early and valuable biomarker of cellular immunity, shown to be a sensitive assessment parameter for cell-mediated immune reactions. Hence determination of neopterin concentrations in distinctive body fluids is of diagnostic interest in a wide range of T lymphocytes and macrophages originated diseases. Read more about this study
- Who is it for?
- Ages 35 to 60 years, women only
- Conditions the study is for
- Menopause
- What is being tested?
- assessment of neopterin levels
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Jan 2019to 30 Apr 2019
- 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 35 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female patients aged from (35- 60).
- Clinically diagnosed with chronic moderate periodontitis having more than 10 natural teeth and at least two teeth exhibiting clinical attachment loss (CAL) ≥4 mm.
- Systemically healthy individuals and not taking any hormonal therapy or drugs that affect hormonal status.
- Patient compliance
Who cannot join
- Smokers.
- Pregnant or lactating females.
- Periodontal treatment <6 months prior to the preliminary visit.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Salivary and Gingival Crevicular Fluid Neopterin Levels in Pre- and Post-menopausal Women With Chronic Periodontitis Following Nonsurgical Periodontal Therapy (A Clinical and Biochemical Study)
Neopterin is an early and valuable biomarker of cellular immunity, shown to be a sensitive assessment parameter for cell-mediated immune reactions. Hence determination of neopterin concentrations in distinctive body fluids is of diagnostic interest in a wide range of T lymphocytes and macrophages originated diseases. Increased neopterin production is also found in infections due to intracellular living bacteria and parasites. Neopterin concentration is directly proportional to the reactive oxygen species levels and is inversely related to the serum concentration of antioxidants like alpha-tocopherol. Hence it can be regarded as a marker of reactive oxygen species formed by the activated cellular immune system. Consequentially this is useful for predicting the prognosis and diagnosis of severe form of periodontal diseases. Menopause accomplishes a wide range of changes in women's body, and the oral cavity is also not exceptional. As exalted levels of ovarian hormones, detected in pregnancy and oral contraceptive usage, can lead to an increase of gingival inflammation. On the contrary, menopause shows depleted levels of ovarian sex steroids, which also causes worsening of gingival health. Post-menopause was found to be more aggressive and destructive in nature compared to pre-menopause. It has been assessed that the prevalence of oral discomfort was found to be significantly higher along with low flow rates of the saliva with the presence of periodontal disease more frequently. Studies demonstrated that non-surgical periodontal therapy reduces inflammation and improves periodontal status. Therefore it can be assumed that overall inflammatory markers also reduce after non-surgical periodontal therapy.
Read the detailed description
A total of 30 patients will be selected, 15 per-menopause and 15 post-menopausal women. Full mouth scaling and root planing will be performed. All clinical parameters will be recorded at the baseline visit before mechanical debridement and after 3 months of treatment. Saliva samples will be collected at the primary visit before scaling and root planing as a baseline value, and after 1 month and 3 months postoperatively. Gingival crevicular fluid (GCF) samples will be collected at the primary visit before scaling and root planing as a baseline value, and after 1 month and 3 months postoperatively. Neopterin will be measured in the samples using commercially available Enzyme Linked Immunosorbent Assay (ELISA) kit. Statistical analysis will be performed to the results.
- Conditions
- Menopause
- Being tested
- assessment of neopterin levels
- Keywords
- Periodontitis, Neopterin, Menopausal women, Non-surgical periodontal therapy
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
assessment of neopterin levelsDiagnostic test
neopterin is a macrophage biomarker used for diagnosis of active periodontitis and the response to treatment
| Study group | Role | What they receive |
|---|---|---|
| saliva neopterin levels | Other | assessment of saliva neopterin levels in pre and post-menopausal women Receives: Diagnostic Test: assessment of neopterin levels |
| GCF neopterin levels | Other | assessment of GCF neopterin levels in pre and post-menopausal women Receives: Diagnostic Test: assessment of neopterin levels |
What is being measured
The primary outcome is the main question the study is designed to answer.
assess salivary and gingival crevicular fluid neopterin levels in patients with chronic periodontitis in pre- and post-menopausal women
measuring of neopterin levels using commercially available ELISA kit
Measured: 3 months
Secondary outcomes (1)
evaluate the value of neopterin as a biomarker
depending on the result, if neopterin is correleated with the disease activity it can be used as a biomarker
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 posted28 Oct 2019
- Study start25 Jan 2019
- Primary completion25 Apr 2019
- Study completion30 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abeer Alaa El-Din, Ain Shams University
- Investigators
- Nevine H. Kheir El Din, Professor, Study director, Faculty of Dentistry- Ain Shams UniversityWaleed M. Abbas, lecturer, Study director, Faculty of Dentistry- Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04141033
- Sponsor's protocol ID
- Abeer Alaa 88
- Status last verified
- Oct 2019
- First submitted
- 19 Oct 2019
- Last updated
- 28 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- 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 28 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Salivary and Gingival Crevicular Fluid Neopterin Levels in Pre- and Post-menopausal Women With Chronic Periodontitis Following Nonsurgical Periodontal Therapy (A Clinical and Biochemical Study)
- ClinicalTrials.gov ID
- NCT04141033
- Acronym / sponsor ID
- Abeer Alaa 88
- Conditions
- Menopause
- Keywords
- Periodontitis, Neopterin, Menopausal women, Non-surgical periodontal therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 25 Jan 2019 (actual)
- Primary completion
- 25 Apr 2019 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 28 Oct 2019 (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.
Neopterin is an early and valuable biomarker of cellular immunity, shown to be a sensitive assessment parameter for cell-mediated immune reactions. Hence determination of neopterin concentrations in distinctive body fluids is of diagnostic interest in a wide range of T lymphocytes and macrophages originated diseases. Increased neopterin production is also found in infections due to intracellular living bacteria and parasites. Neopterin concentration is directly proportional to the reactive oxygen species levels and is inversely related to the serum concentration of antioxidants like alpha-tocopherol. Hence it can be regarded as a marker of reactive oxygen species formed by the activated cellular immune system. Consequentially this is useful for predicting the prognosis and diagnosis of severe form of periodontal diseases. Menopause accomplishes a wide range of changes in women's body, and the oral cavity is also not exceptional. As exalted levels of ovarian hormones, detected in pregnancy and oral contraceptive usage, can lead to an increase of gingival inflammation. On the contrary, menopause shows depleted levels of ovarian sex steroids, which also causes worsening of gingival health. Post-menopause was found to be more aggressive and destructive in nature compared to pre-menopause. It has been assessed that the prevalence of oral discomfort was found to be significantly higher along with low flow rates of the saliva with the presence of periodontal disease more frequently. Studies demonstrated that non-surgical periodontal therapy reduces inflammation and improves periodontal status. Therefore it can be assumed that overall inflammatory markers also reduce after non-surgical periodontal therapy.
Detailed description
A total of 30 patients will be selected, 15 per-menopause and 15 post-menopausal women. Full mouth scaling and root planing will be performed. All clinical parameters will be recorded at the baseline visit before mechanical debridement and after 3 months of treatment. Saliva samples will be collected at the primary visit before scaling and root planing as a baseline value, and after 1 month and 3 months postoperatively. Gingival crevicular fluid (GCF) samples will be collected at the primary visit before scaling and root planing as a baseline value, and after 1 month and 3 months postoperatively. Neopterin will be measured in the samples using commercially available Enzyme Linked Immunosorbent Assay (ELISA) kit. Statistical analysis will be performed to the results.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| saliva neopterin levels | Other | Diagnostic Test: assessment of neopterin levelsassessment of saliva neopterin levels in pre and post-menopausal women |
| GCF neopterin levels | Other | Diagnostic Test: assessment of neopterin levelsassessment of GCF neopterin levels in pre and post-menopausal women |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Female patients aged from (35- 60).
- Clinically diagnosed with chronic moderate periodontitis having more than 10 natural teeth and at least two teeth exhibiting clinical attachment loss (CAL) ≥4 mm.
- Systemically healthy individuals and not taking any hormonal therapy or drugs that affect hormonal status.
- Patient compliance
Key exclusion criteria (3 listed)
- Smokers.
- Pregnant or lactating females.
- Periodontal treatment <6 months prior to the preliminary visit.
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 |
|---|---|---|
| assessment of neopterin levelsneopterin is a macrophage biomarker used for diagnosis of active periodontitis and the response to treatment | Diagnostic test | GCF neopterin levels, saliva neopterin levels |
Primary outcome
assess salivary and gingival crevicular fluid neopterin levels in patients with chronic periodontitis in pre- and post-menopausal women
Time frame: 3 months
measuring of neopterin levels using commercially available ELISA kit
1 secondary outcome
evaluate the value of neopterin as a biomarker
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 28 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.
Nevine H. Kheir El Din, Professor study director
Faculty of Dentistry- Ain Shams University
Waleed M. Abbas, lecturer study director
Faculty of Dentistry- Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing assessment of neopterin levels in people with Menopause, run by Ain Shams University 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 3 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 28 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 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?
assess salivary and gingival crevicular fluid neopterin levels in patients with chronic periodontitis in pre- and post-menopausal women (time frame: 3 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 28 Oct 2019.