An interventional study of assessment of neopterin levels in Menopause, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to female participants aged 35 Years to 60 Years. Per ClinicalTrials.gov, last updated 2019-10-28.
Sponsored by Ain Shams University · Not applicable, Interventional, and Diagnostic
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.
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.
1,664 studies on the registry are indexed under Periodontitis; 328 are open to participants now.
This study's enrollment of 30 is below the median of 45 across 1,206 interventional studies indexed under Periodontitis.
Browse Periodontitis studies →Ain Shams University is the lead sponsor of 1,930 studies on the registry; 433 are open to participants now.
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Exclusion Criteria:
assessment of saliva neopterin levels in pre and post-menopausal women
Diagnostic Test: assessment of neopterin levels
assessment of GCF neopterin levels in pre and post-menopausal women
Diagnostic Test: assessment of neopterin levels
neopterin is a macrophage biomarker used for diagnosis of active periodontitis and the response to treatment
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
Time frame: 3 months
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
Time frame: 3 months
Plan to share: No
No publications or documents are linked to this record.
Ran from Jan 2019 to primary completion in Apr 2019, 3 months.
Of 605 non-industry interventional studies with no phase under Periodontitis, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 28. This study's 3 months is below that.
Counting every sponsor, half of 624 studies reached it within 15 months; a quarter within 7 and three quarters within 28.
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This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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