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

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.

Study Overview

• Status: Completed
• Conditions: Menopause
• Intervention / Treatment: Diagnostic test: assessment of neopterin levels

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 1156
    • Ain Shams University- Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: saliva neopterin levels; assessment of saliva 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
OTHER: GCF 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	3 months

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Study Director: Nevine H. Kheir El Din, Professor, Faculty of Dentistry- Ain Shams University; Study Director: Waleed M. Abbas, lecturer, Faculty of Dentistry- Ain Shams University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 25, 2019
• Primary Completion (ACTUAL): April 25, 2019
• Study Completion (ACTUAL): April 30, 2019

Study Registration Dates

• First Submitted: October 19, 2019
• First Submitted That Met QC Criteria: October 24, 2019
• First Posted (ACTUAL): October 28, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 28, 2019
• Last Update Submitted That Met QC Criteria: October 24, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Periodontitis; Menopausal women; Non-surgical periodontal therapy; Neopterin
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Chronic Periodontitis
• Other Study ID Numbers: Abeer Alaa 88

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No