PeriodontitisPhase 1/2EPRNPPMPNCT02718014
Evaluation of Periodontal Response to Non Surgical Therapy in Pre and Post Menopausal Women With Periodontitis
A Phase 1/2 study testing scaling and root planing (srp) in people with Periodontitis and Menopause, run by Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre.
Trial summary
The present study was evaluated periodontal status in pre and post-menopausal women with periodontitis following non-surgical therapy. 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, Menopause, Plaque
- What is being tested?
- scaling and root planing (srp)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Aug 2015
- Phase
- Phase 1/2
- 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
Who may be able to join
None listed.
Who cannot join
- 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.
About this study
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.
- Conditions
- Periodontitis, Menopause, Plaque, Inflammation
- Being tested
- scaling and root planing (srp)
- Keywords
- Non Surgical Therapy
- Medical subject headings
- Periodontitis, Plaque, Amyloid, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
scaling and root planing (srp)Other
| Study group | Role | What they receive |
|---|---|---|
| pre menopause with periodontitis | Other | non surgical periodontal therapy (SCALING \& ROOT PLANING) (SRP) Receives: Other: scaling and root planing (srp) |
| post menopause with periodontitis | Other | non surgical periodontal therapy (SCALING \& ROOT PLANING) (SRP) Receives: Other: scaling and root planing (srp) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of periodontal response to non surgical therapy in pre and post menopausal women with periodontitis
pocket depth reduction calculated with PRI index
Measured: 3 months
Evaluation of periodontal response to non surgical therapy in pre and post menopausal
plaque scores was calculated with Silness and Loe index
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 posted24 Mar 2016 (estimated)
- Study startJan 2015
- Primary completionApr 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, J S Prasanna, Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02718014
- Sponsor's protocol ID
- PMVIDSRC
- Acronym
- EPRNPPMP
- Status last verified
- Mar 2016
- First submitted
- 11 Mar 2016
- Last updated
- 24 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
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 19652040Deasy MJ, Vogel RI. Female sex hormonal factors in periodontal disease. Ann Dent. 1976 Fall;35(3):42-6.
PubMed 788632Aznar 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 4195183Yobs 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 3425152Tobin 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
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Periodontal Response to Non Surgical Therapy in Pre and Post Menopausal Women With Periodontitis
- ClinicalTrials.gov ID
- NCT02718014
- Acronym / sponsor ID
- EPRNPPMP / PMVIDSRC
- Conditions
- Periodontitis, Menopause, Plaque, Inflammation
- Keywords
- Non Surgical Therapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Panineeya Mahavidyalaya Institute of Dental Sciences & Research CentreUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Apr 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 24 Mar 2016 (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.
The present study was evaluated periodontal status in pre and post-menopausal women with periodontitis following non-surgical therapy.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pre menopause with periodontitis | Other | Other: scaling and root planing (srp)non surgical periodontal therapy (SCALING \& ROOT PLANING) (SRP) |
| post menopause with periodontitis | Other | Other: scaling and root planing (srp)non surgical periodontal therapy (SCALING \& ROOT PLANING) (SRP) |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| scaling and root planing (srp) | Other | post menopause with periodontitis, pre menopause with periodontitis |
Primary outcome
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2016.
- Background: PubMed 19652040Buencamino 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.
- Background: PubMed 788632Deasy MJ, Vogel RI. Female sex hormonal factors in periodontal disease. Ann Dent. 1976 Fall;35(3):42-6.
- Background: PubMed 4195183Aznar 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.
- Results publication: PubMed 3425152Yobs 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.
- Results publication: PubMed 3793432Tobin 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.
- Individual participant dataSharing planned: No
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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?
A Phase 1/2 study testing scaling and root planing (srp) in people with Periodontitis and Menopause, 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 0 inclusion and 8 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: finished, as of the sponsor's last update on 24 Mar 2016. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Evaluation of periodontal response to non surgical therapy in pre and post menopausal women with periodontitis (time frame: 3 months). The study lists 2 primary outcomes in all. 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 NCT02718014, which also lists 5 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 24 Mar 2016.