Clinical trial NCT04141033: 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
Overall status: COMPLETED
Phase: NA
Conditions: Menopause
Keywords: Periodontitis
Neopterin
Menopausal women
Non-surgical periodontal therapy
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2019-10-28
Enrollment: 30
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: assess salivary and gingival crevicular fluid neopterin levels in patients with chronic periodontitis in pre- and post-menopausal women
timeFrame: 3 months
Secondary outcomes:
measure: evaluate the value of neopterin as a biomarker
timeFrame: 3 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University- Faculty of Dentistry
Study officials:
affiliation: Faculty of Dentistry- Ain Shams University
name: Nevine H. Kheir El Din, Professor
role: STUDY_DIRECTOR
affiliation: Faculty of Dentistry- Ain Shams University
name: Waleed M. Abbas, lecturer
role: STUDY_DIRECTOR
References: