- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02718014
Evaluation of Periodontal Response to Non Surgical Therapy in Pre and Post Menopausal Women With Periodontitis (EPRNPPMP)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
AIM: The aim of the present study was to evaluate periodontal status in pre and post-menopausal women with periodontitis following non-surgical therapy.
MATERIALS AND METHODS: Periodontal status was measured by Periodontal index (PRI), and oral hygiene status was measured by plaque index (PI). Both the parameters were measured at baseline i.e before Scaling and Root Planing (SRP) and after 3 months intervals post treatment. SRP was done in both pre&post menopause groups.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:Patients should have at least 15 natural teeth remaining
- Non smokers
- Systemically healthy from past 6 months
Exclusion Criteria:Present or past smokers
- Below 40 years of age
- With gross oral pathology or tumors
- Patients on long term steroid medication
- Undergoing Hormone replacement therapy (HRT)
- Pregnant women or planning for pregnancy
- Those who have received periodontal therapy in the preceding 6 months
- Those that are under medication in the preceding 6 months
- Any systemic disorders or any medication that affects the periodontal status was excluded from this study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: pre menopause with periodontitis
non surgical periodontal therapy (SCALING & ROOT PLANING) (SRP)
|
|
Other: post menopause with periodontitis
non surgical periodontal therapy (SCALING & ROOT PLANING) (SRP)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of periodontal response to non surgical therapy in pre and post menopausal women with periodontitis
Time Frame: 3 months
|
pocket depth reduction calculated with PRI index
|
3 months
|
Evaluation of periodontal response to non surgical therapy in pre and post menopausal
Time Frame: 3 months
|
plaque scores was calculated with Silness and Loe index
|
3 months
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Buencamino MC, Palomo L, Thacker HL. How menopause affects oral health, and what we can do about it. Cleve Clin J Med. 2009 Aug;76(8):467-75. doi: 10.3949/ccjm.76a.08095.
- Deasy MJ, Vogel RI. Female sex hormonal factors in periodontal disease. Ann Dent. 1976 Fall;35(3):42-6.
- Aznar Reig A, Zamora Madarias E, Bonilla Mir F, Lopez Campos J, Majua Delgado R. [Hepatic satelite lesion in biliary calculi]. Rev Esp Enferm Apar Dig. 1968 Aug-Sep;27(7):1019-40. No abstract available. Spanish.
- Yobs AR, Plott AE, Hicklin MD, Coleman SA, Johnston WW, Ashton PR, Rube IF, Watts JC, Naib ZM, Wood RJ, et al. Retrospective evaluation of gynecologic cytodiagnosis. II. Interlaboratory reproducibility as shown in rescreening large consecutive samples of reported cases. Acta Cytol. 1987 Nov-Dec;31(6):900-10.
- Tobin JO, Watkins ID, Woodhead S, Mitchell RG. Epidemiological studies using monoclonal antibodies to Legionella pneumophila serogroup 1. Isr J Med Sci. 1986 Oct;22(10):711-4.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PMVIDSRC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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