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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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CTRI |
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Last refreshed on:
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24 November 2021 |
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Main ID: |
CTRI/2018/01/011575 |
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Date of registration:
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29-01-2018 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effect Of Periodontal Therapy On pregnancy duration of Pregnant Women and Birth Weight Of New Born
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Scientific title:
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Effect Of Periodontal Therapy On Gestational Age of Pregnant Women And Birth Weight Of Corresponding New Borns - A Randomized Control Trial |
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Date of first enrolment:
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20-01-2016 |
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Target sample size:
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100 |
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Recruitment status: |
Completed |
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URL:
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http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=17343 |
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Study type:
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Interventional |
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Study design:
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Randomized, Parallel Group Trial
Method of generating randomization sequence:Random Number Table Method of allocation concealment:Case Record Numbers Blinding and masking:Outcome Assessor Blinded
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Phase:
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N/A
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Countries of recruitment
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India
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Contacts
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Name:
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Dr Jaseela Praveena
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Address:
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Department of Public Health Dentistry,
K.V.G Dental college and Hospital,
Sullia, D.K
574239
Dakshina Kannada, KARNATAKA
India |
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Telephone:
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9611096603 |
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Email:
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dentisthemu@gmail.com |
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Affiliation:
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K.V.G Dental college and Hospital |
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Name:
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Dr Hemant Battur
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Address:
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Department of Public Health Dentistry,
K.V.G Dental college and Hospital,
Sullia, D.K
574239
Dakshina Kannada, KARNATAKA
India |
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Telephone:
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9611096603 |
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Email:
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dentisthemu@gmail.com |
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Affiliation:
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K.V.G Dental college and Hospital |
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Key inclusion & exclusion criteria
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Inclusion criteria: Primigravidae in their first trimester having a D component (DMFT) of zero with an informed consent were included in this study.
Exclusion criteria: Any Systemic condition/diseases that may lead to preterm delivery /LBW as determined by the concerned physician/ gynaecologist. Multifetal / ectopic pregnancies were excluded. Data from participants of control group needing periodontal treatment during the term were excluded from analysis. Stillbirths/infants with congenital anomalies were excluded from the analysis.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Health Condition 1: O268- Other specified pregnancy relatedconditions
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Intervention(s)
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Intervention1: Non surgical periodontal treatment: oral prophylaxis, oral hygiene instructions, brushing technique,diet councelling, advanced periodontal therapy( if required)
Control Intervention1: controls: oral hygiene instructions, brushing technique demonstration
and diet counselling at group and individual level
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Primary Outcome(s)
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Birth weight
gestational age
Timepoint: at delivery
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Secondary Outcome(s)
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periodontal statusTimepoint: first trimester
third trimester
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Source(s) of Monetary Support
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K.V.G medical college and Hospital, Kurunjhibhag, Sullia, Dakdhina kannada, Karnataka 574239;
Vivas Hospital, Daswal Road, Opp. Basappa Theatere, Madikeri, Karnataka 571201
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Ethics review
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Status: Approved
Approval date: 20/11/2015
Contact:
Institutional ethical committee
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Results
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Results available:
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Date Posted:
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Date Completed:
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04/02/2017 |
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URL:
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