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CompletedNCT02718014EPRNPPMPUpdated Mar 24, 2016

Evaluation of Periodontal Response to Non Surgical Therapy in Pre and Post Menopausal Women With Periodontitis

A Phase 1/2 interventional study of scaling and root planing (srp) in Periodontitis, Menopause and Plaque, sponsored by Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre. Completed. Open to female participants aged 40 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-03-24.

Sponsored by Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre · Phase 1/2, Interventional, and Supportive care

Phase
Phase 1/2
Study type
Interventional
Enrollment
60
Allocation
Non-randomized
Ages
40 Years to 60 Years
Sex
Female
01

Study summary

The present study was evaluated periodontal status in pre and post-menopausal women with periodontitis following non-surgical therapy.

Read the 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.

02

Conditions studied

  • Periodontitis
  • Menopause
  • Plaque
  • Inflammation

Keywords

  • Non Surgical Therapy
03

In context

Periodontitis

1,634 studies on the registry are indexed under Periodontitis; 327 are open to participants now.

This study's enrollment of 60 is above the median of 45 across 1,191 interventional studies indexed under Periodontitis.

Browse Periodontitis studies →

Lead sponsor

Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre is the lead sponsor of 25 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 60 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Eligibility criteria

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.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Supportive care
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • Other
    pre menopause with periodontitis

    non surgical periodontal therapy (SCALING \& ROOT PLANING) (SRP)

    Other: scaling and root planing (srp)

  • Other
    post menopause with periodontitis

    non surgical periodontal therapy (SCALING \& ROOT PLANING) (SRP)

    Other: scaling and root planing (srp)

Interventions

  • Otherscaling and root planing (srp)
06

What researchers measure

Primary outcomes

  1. Evaluation of periodontal response to non surgical therapy in pre and post menopausal women with periodontitis

    pocket depth reduction calculated with PRI index

    Time frame: 3 months

  2. Evaluation of periodontal response to non surgical therapy in pre and post menopausal

    plaque scores was calculated with Silness and Loe index

    Time frame: 3 months

07

Study locations

No study locations are listed for this record.

08

References and documents

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. PubMed 19652040 ↗
  • Deasy MJ, Vogel RI. Female sex hormonal factors in periodontal disease. Ann Dent. 1976 Fall;35(3):42-6. PubMed 788632 ↗
  • 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. PubMed 4195183 ↗
  • 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. PubMed 3425152 ↗
  • 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. PubMed 3793432 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 24, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02718014
Lead sponsor
Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
Responsible party
J S Prasanna (DR, Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre) — Principal investigator
First posted
Mar 24, 2016
Start date
Jan 2015
Primary completion
Apr 2015
Completion
Aug 2015
Last update
Mar 24, 2016

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.

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