Assessment of Neopterin Levels in Pre- and Post-menopausal Women With Chronic Periodontitis

NCT ID: NCT04141033

Last Updated: 2019-10-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-25
• Study Completion Date: 2019-04-30

Brief 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. 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.

Conditions

Menopause

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

saliva neopterin levels

assessment of saliva neopterin levels in pre and post-menopausal women

Group Type: OTHER

assessment of neopterin levels

Intervention Type: DIAGNOSTIC_TEST

neopterin is a macrophage biomarker used for diagnosis of active periodontitis and the response to treatment

GCF neopterin levels

assessment of GCF neopterin levels in pre and post-menopausal women

Group Type: OTHER

assessment of neopterin levels

Intervention Type: DIAGNOSTIC_TEST

neopterin is a macrophage biomarker used for diagnosis of active periodontitis and the response to treatment

Interventions

assessment of neopterin levels

neopterin is a macrophage biomarker used for diagnosis of active periodontitis and the response to treatment

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• Smokers.
• Pregnant or lactating females.
• Periodontal treatment <6 months prior to the preliminary visit.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Abeer Alaa El-Din

Master student at Ain Shams University Faculty of Dentistry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nevine H. Kheir El Din, Professor

Role: STUDY_DIRECTOR

Faculty of Dentistry- Ain Shams University

Waleed M. Abbas, lecturer

Role: STUDY_DIRECTOR

Faculty of Dentistry- Ain Shams University

Locations

Ain Shams University- Faculty of Dentistry

Cairo, , Egypt

Countries

Egypt

Other Identifiers

Abeer Alaa 88

Identifier Type: -

Identifier Source: org_study_id