NCT02718014

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2015

Shorter than P25 for phase_1

Status
completed

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

Study Start

First participant enrolled

January 1, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 11, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 24, 2016

Completed
Last Updated

March 24, 2016

Status Verified

March 1, 2016

Enrollment Period

3 months

First QC Date

March 11, 2016

Last Update Submit

March 18, 2016

Conditions

PeriodontitisMenopausePlaqueInflammation

Keywords

Non Surgical Therapy

Outcome Measures

Primary Outcomes (2)

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

    pocket depth reduction calculated with PRI index

    3 months

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

    plaque scores was calculated with Silness and Loe index

    3 months

Study Arms (2)

pre menopause with periodontitis

OTHER

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

Other: scaling and root planing (srp)

post menopause with periodontitis

OTHER

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

Other: scaling and root planing (srp)

Interventions

scaling and root planing (srp)OTHER
post menopause with periodontitispre menopause with periodontitis

Eligibility Criteria

Age40 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Non smokers
  • Systemically healthy from past 6 months

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • 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.

    PMID: 19652040BACKGROUND

  • Deasy MJ, Vogel RI. Female sex hormonal factors in periodontal disease. Ann Dent. 1976 Fall;35(3):42-6.

    PMID: 788632BACKGROUND

  • 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.

    PMID: 4195183BACKGROUND

  • 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.

    PMID: 3425152RESULT

  • 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.

    PMID: 3793432RESULT

MeSH Terms

Conditions

PeriodontitisPlaque, AmyloidInflammation

Interventions

Tooth ExfoliationRoot PlaningUrocortins

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsPathologic Processes

Intervention Hierarchy (Ancestors)

Dental Physiological PhenomenaDigestive System and Oral Physiological PhenomenaDental ScalingDental ProphylaxisPeriodonticsDentistrySubgingival CurettagePreventive DentistryPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DR

Study Record Dates

First Submitted

March 11, 2016

First Posted

March 24, 2016

Study Start

January 1, 2015

Primary Completion

April 1, 2015

Study Completion

August 1, 2015

Last Updated

March 24, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share