NCT04141033

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 25, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2019

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 19, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 28, 2019

Completed
Last Updated

October 28, 2019

Status Verified

October 1, 2019

Enrollment Period

3 months

First QC Date

October 19, 2019

Last Update Submit

October 24, 2019

Conditions

Menopause

Keywords

PeriodontitisNeopterinMenopausal womenNon-surgical periodontal therapy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • evaluate the value of neopterin as a biomarker

    3 months

Study Arms (2)

saliva neopterin levels

OTHER

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

Diagnostic Test: assessment of neopterin levels

GCF neopterin levels

OTHER

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

Diagnostic Test: assessment of neopterin levels

Interventions

assessment of neopterin levelsDIAGNOSTIC_TEST

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

GCF neopterin levelssaliva neopterin levels

Eligibility Criteria

Age35 Years - 60 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailssubjects are categorized depending on menstrual history
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University- Faculty of Dentistry

Cairo, 1156, Egypt

Location

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • 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 DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master student at Ain Shams University Faculty of Dentistry

Study Record Dates

First Submitted

October 19, 2019

First Posted

October 28, 2019

Study Start

January 25, 2019

Primary Completion

April 25, 2019

Study Completion

April 30, 2019

Last Updated

October 28, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)