- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02357745
Evaluation of Neopterin Levels in Pre and Post-menopausal Women With Periodontitis Following Non Surgical Therapy (ENLPPMNS)
February 5, 2015 updated by: DR.CH.SUMADHURA, Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
Biochemical Evaluation of Plasma,Urine and Salivary Neopterin Levels in Pre and Post-menopausal Women With Periodontitis Following Non-surgical Therapy
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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
Study Type
Observational
Enrollment (Anticipated)
30
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 60 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
15 pre-menopausal women with periodontitis 15 post-menopausal women with periodontitis
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Pre-menopausal with periodontitis
non surgical periodontal therapy ( scaling and root planing)
|
scaling and root planing
|
Post-menopausal with periodontitis
non surgical periodontal therapy ( scaling and root planing)
|
scaling and root planing
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Co-relating neopterin and periodontitis levels in pre and post menopausal women
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2015
Primary Completion (Anticipated)
May 1, 2015
Study Completion (Anticipated)
May 1, 2015
Study Registration Dates
First Submitted
January 21, 2015
First Submitted That Met QC Criteria
February 5, 2015
First Posted (Estimate)
February 6, 2015
Study Record Updates
Last Update Posted (Estimate)
February 6, 2015
Last Update Submitted That Met QC Criteria
February 5, 2015
Last Verified
January 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- suma thesis
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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