PeriodontitisENLPPMNSNCT02357745
Evaluation of Neopterin Levels in Pre and Post-menopausal Women With Periodontitis Following Non Surgical Therapy
An observational study of Periodontitis, run by Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Periodontitis
- What is being tested?
- Non surgical periodontal therapy
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Feb 2015to May 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: 15 pre-menopausal women with periodontitis 15 post-menopausal women with periodontitis
Who may be able to join
- moderate to chronic periodontitis
- non-smokers
- minimum 15 natural teeth present
Who cannot join
- 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
About this study
Official title: 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.
Read the 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
- Conditions
- Periodontitis
- Being tested
- Non surgical periodontal therapy
- Keywords
- neopterin, plasma, urine, saliva, menopause, periodontitis
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non surgical periodontal therapyProcedure or surgery
scaling and root planing
| Study group | Role | What they receive |
|---|---|---|
| Pre-menopausal with periodontitis | non surgical periodontal therapy ( scaling and root planing) Receives: Procedure: Non surgical periodontal therapy | |
| Post-menopausal with periodontitis | non surgical periodontal therapy ( scaling and root planing) Receives: Procedure: Non surgical periodontal therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Co-relating neopterin and periodontitis levels in pre and post menopausal women
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completionMay 2015 (estimated)
- Study completionMay 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DR.CH.SUMADHURA, Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02357745
- Sponsor's protocol ID
- suma thesis
- Acronym
- ENLPPMNS
- Status last verified
- Jan 2015
- First submitted
- 21 Jan 2015
- Last updated
- 6 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 16636374Arjunkumar 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.
PubMed 24355959Pradeep 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.
PubMed 18062118Ozmeric 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.
PubMed 12146530Vrecko 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.
PubMed 9495569Bakhtadze 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.
PubMed 16510912
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biochemical Evaluation of Plasma,Urine and Salivary Neopterin Levels in Pre and Post-menopausal Women With Periodontitis Following Non-surgical Therapy
- ClinicalTrials.gov ID
- NCT02357745
- Acronym / sponsor ID
- ENLPPMNS / suma thesis
- Conditions
- Periodontitis
- Keywords
- neopterin, plasma, urine, saliva, menopause, periodontitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Panineeya Mahavidyalaya Institute of Dental Sciences & Research CentreUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- May 2015 (estimated)
- Study completion
- May 2015 (estimated)
- First posted
- 6 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-menopausal with periodontitis | – | Procedure: Non surgical periodontal therapynon surgical periodontal therapy ( scaling and root planing) |
| Post-menopausal with periodontitis | – | Procedure: Non surgical periodontal therapynon surgical periodontal therapy ( scaling and root planing) |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 15 pre-menopausal women with periodontitis 15 post-menopausal women with periodontitis
Key inclusion criteria (3 listed)
- moderate to chronic periodontitis
- non-smokers
- minimum 15 natural teeth present
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non surgical periodontal therapyscaling and root planing | Procedure or surgery | Post-menopausal with periodontitis, Pre-menopausal with periodontitis |
Primary outcome
Co-relating neopterin and periodontitis levels in pre and post menopausal women
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2015.
- Background: PubMed 16636374Bakhtadze 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.
- Results publication: PubMed 24355959Arjunkumar 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.
- Results publication: PubMed 18062118Pradeep 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.
- Results publication: PubMed 12146530Ozmeric 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.
- Results publication: PubMed 9495569Vrecko 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.
- Results publication: PubMed 16510912Bakhtadze 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontitis, run by Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Co-relating neopterin and periodontitis levels in pre and post menopausal women (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02357745, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2015.