NCT02357745

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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2015

Shorter than P25 for all trials

Status
unknown

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

First Submitted

Initial submission to the registry

January 21, 2015

Completed
11 days until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 6, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

February 6, 2015

Status Verified

January 1, 2015

Enrollment Period

3 months

First QC Date

January 21, 2015

Last Update Submit

February 5, 2015

Conditions

Periodontitis

Keywords

neopterinplasmaurinesalivamenopauseperiodontitis

Outcome Measures

Primary Outcomes (1)

  • Co-relating neopterin and periodontitis levels in pre and post menopausal women

    3 months

Study Arms (2)

Pre-menopausal with periodontitis

non surgical periodontal therapy ( scaling and root planing)

Procedure: Non surgical periodontal therapy

Post-menopausal with periodontitis

non surgical periodontal therapy ( scaling and root planing)

Procedure: Non surgical periodontal therapy

Interventions

Non surgical periodontal therapyPROCEDURE

scaling and root planing

Post-menopausal with periodontitisPre-menopausal with periodontitis

Eligibility Criteria

Age40 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

15 pre-menopausal women with periodontitis 15 post-menopausal women with periodontitis

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • 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.

    PMID: 16636374BACKGROUND

  • 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.

    PMID: 24355959RESULT

  • 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.

    PMID: 18062118RESULT

  • 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.

    PMID: 12146530RESULT

  • 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.

    PMID: 9495569RESULT

  • 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.

    PMID: 16510912RESULT

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
SUMADHURA

Study Record Dates

First Submitted

January 21, 2015

First Posted

February 6, 2015

Study Start

February 1, 2015

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

February 6, 2015

Record last verified: 2015-01