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

Primary Purpose

Menopause

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
assessment of neopterin levels
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Menopause focused on measuring Periodontitis, Neopterin, Menopausal women, Non-surgical periodontal therapy

Eligibility Criteria

35 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Ain Shams University- Faculty of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

saliva neopterin levels

GCF neopterin levels

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 19, 2019
Last Updated
October 24, 2019
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT04141033
Brief Title
Assessment of Neopterin Levels in Pre- and Post-menopausal Women With Chronic Periodontitis
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)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
January 25, 2019 (Actual)
Primary Completion Date
April 25, 2019 (Actual)
Study Completion Date
April 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Menopause
Keywords
Periodontitis, Neopterin, Menopausal women, Non-surgical periodontal therapy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
saliva neopterin levels
Arm Type
Other
Arm Description
assessment of saliva neopterin levels in pre and post-menopausal women
Arm Title
GCF neopterin levels
Arm Type
Other
Arm Description
assessment of GCF neopterin levels in pre and post-menopausal women
Intervention Type
Diagnostic Test
Intervention Name(s)
assessment of neopterin levels
Intervention Description
neopterin is a macrophage biomarker used for diagnosis of active periodontitis and the response to treatment
Primary Outcome Measure Information:
Title
assess salivary and gingival crevicular fluid neopterin levels in patients with chronic periodontitis in pre- and post-menopausal women
Description
measuring of neopterin levels using commercially available ELISA kit
Time Frame
3 months
Secondary Outcome Measure Information:
Title
evaluate the value of neopterin as a biomarker
Description
depending on the result, if neopterin is correleated with the disease activity it can be used as a biomarker
Time Frame
3 months

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
subjects are categorized depending on menstrual history
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nevine H. Kheir El Din, Professor
Organizational Affiliation
Faculty of Dentistry- Ain Shams University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Waleed M. Abbas, lecturer
Organizational Affiliation
Faculty of Dentistry- Ain Shams University
Official's Role
Study Director
Facility Information:
Facility Name
Ain Shams University- Faculty of Dentistry
City
Cairo
ZIP/Postal Code
1156
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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