Clinical trial NCT02357745: Evaluation of Neopterin Levels in Pre and Post-menopausal Women With Periodontitis Following Non Surgical Therapy
Official title: Biochemical Evaluation of Plasma,Urine and Salivary Neopterin Levels in Pre and Post-menopausal Women With Periodontitis Following Non-surgical Therapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Periodontitis
Keywords: neopterin
plasma
urine
saliva
menopause
periodontitis
Lead sponsor: Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
Sponsor class: OTHER
First posted: 2015-02-06
Enrollment: 30
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 15 pre-menopausal women with periodontitis 15 post-menopausal women with periodontitis

Brief summary: Neopterin has been identified as a marker of cellular immune system activation. It is synthesized by macrophages upon stimulation with the cytokine interferon-gamma and is indicative of a pro-inflammatory immune status. Neopterin concentration increases with increasing severity of periodontal disease in diverse body fluids like Urine, Saliva and Plasma. Hence Neopterin can be considered as an important inflammatory marker in periodontal disease as well as other systemic diseases.

Detailed description: At baseline - plasma, urine and saliva samples were collected and analysed for neopterin levels from the pre and post-menopausal women with periodontitis . Followed by scaling and root planing done in both the groups. After 3 months again these 3 samples were collected and analysed for post treatment neopterin levels

Eligibility criteria: Inclusion Criteria:

* moderate to chronic periodontitis
* non-smokers
* minimum 15 natural teeth present

Exclusion Criteria:

* patients on long term steroid medication
* with gross oral pathology or tumors
* undergoing hormone replacement therapy
* not undergone periodontal therapy in past 6 months
* under medication in past 6 months
* systemic disorders and drugs which influence the periodontium

Primary outcomes:
measure: Co-relating neopterin and periodontitis levels in pre and post menopausal women
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Bakhtadze MG, Margvelashvili VV, Kamkamidze GK. [Interferon-gamma and neopterin in blood serum of patients with chronic periodontitis after autograft operations]. Georgian Med News. 2006 Mar;(132):30-3. Russian.
citation: Arjunkumar R, Sudhakar U, Jayakumar P, Arunachalam L, Suresh S, Virupapuram P. Comparative analysis of gingival crevicular fluid neopterin levels in health and periodontal disease: a biochemical study. Indian J Dent Res. 2013 Sep-Oct;24(5):582-6. doi: 10.4103/0970-9290.123376.
citation: Pradeep AR, Kumar MS, Ramachandraprasad MV, Shikha C. Gingival crevicular fluid levels of neopterin in healthy subjects and in patients with different periodontal diseases. J Periodontol. 2007 Oct;78(10):1962-7. doi: 10.1902/jop.2007.070096.
citation: Ozmeric N, Baydar T, Bodur A, Engin AB, Uraz A, Eren K, Sahin G. Level of neopterin, a marker of immune cell activation in gingival crevicular fluid, saliva, and urine in patients with aggressive periodontitis. J Periodontol. 2002 Jul;73(7):720-5. doi: 10.1902/jop.2002.73.7.720.
citation: Vrecko K, Staedtler P, Mischak I, Maresch L, Reibnegger G. Periodontitis and concentrations of the cellular immune activation marker neopterin in saliva and urine. Clin Chim Acta. 1997 Dec 10;268(1-2):31-40. doi: 10.1016/s0009-8981(97)00154-x.
citation: Bakhtadze MG, Margvelashvili VV, Kamkamidze GK. [Interferon-gamma and neopterin in blood serum of patients with chronic periodontitis]. Georgian Med News. 2006 Jan;(130):50-3. Russian.