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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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29 April 2024 |
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Main ID: |
CTRI/2023/04/052053 |
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Date of registration:
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27-04-2023 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Evaluation of a novel isolating pad during dental treatment
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Scientific title:
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Comparative evaluation of effectiveness of SapDent- a novel isolating pad and conventional cotton rolls as an isolating technique during dental treatment -A randomized control trial - CCT |
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Date of first enrolment:
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20-05-2023 |
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Target sample size:
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86 |
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Recruitment status: |
Open to Recruitment |
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URL:
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http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=82487 |
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Study type:
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Interventional |
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Study design:
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Randomized, Parallel Group, Active Controlled Trial Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Investigator 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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Karthika kk
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Address:
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Dept. of pediatric dentistry, Government Dental College and Hospital, Nagpur, Govt. Medical Campus, Hanuman Nagar, Nagpur, MAHARASHTRA 440003
India
Government Dental College and Hospital, Nagpur, Govt. Medical Campus, Hanuman Nagar, Nagpur, MAHARASHTRA 4
440003
Nagpur, MAHARASHTRA
India |
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Telephone:
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8767732617 |
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Email:
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karthikakrishnakumar27@gmail.com |
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Affiliation:
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Government Dental College and Hospital Nagpur |
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Name:
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Karthika kk
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Address:
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Dept. of pediatric dentistry, Government Dental College and Hospital, Nagpur, Govt. Medical Campus, Hanuman Nagar, Nagpur, MAHARASHTRA 440003
India
Government Dental College and Hospital, Nagpur, Govt. Medical Campus, Hanuman Nagar, Nagpur, MAHARASHTRA 4
440003
Nagpur, MAHARASHTRA
India |
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Telephone:
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8767732617 |
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Email:
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karthikakrishnakumar27@gmail.com |
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Affiliation:
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Government Dental College and Hospital Nagpur |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Children of age 5-12 years
2. Children who need class I restoration on primary second molar or permanent first molar
3. Children with Frankel behaviour rating 3 or 4
Exclusion criteria: 1. Medically compromised children
2. Lack of patient and parental cooperation
3. Parent unwilling to participate in the study
4. Children who are allergic to acrylate
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Health Condition 1: K029- Dental caries, unspecified
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Intervention(s)
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Intervention1: SapDent Isolation technique: The effectiveness of SapDent- a novel isolating pad will be evaluated from the chair side time required for dental treatment, number of isolation pads required, the frequency of isolation pads changed during cavity preparation and restoration of carious teeth in children.
Children’s acceptance and comfort with isolation technique performed will be evaluated using the questionnaire administered to the children. Effectiveness of isolation technique performed according to operator will be evaluated using the questionnaire administered to the operator.
Duration of the intervention - range of 5-15 minutes with Sapdent isolating pads and single visit treatment .
Control Intervention1: Conventional cotton roll isolation technique: The effectiveness of conventional cotton roll will be evaluated from the chair side time required for dental treatment, number of isolation pads required, the frequency of isolation pads changed during cavity preparation and restoration of carious teeth in children.
Children’s acceptance and comfort with isolation technique performed will be evaluated using the questionnaire administered to the children. Effectiveness of isolation technique performed according to operator will be evaluated using the questionnaire administered to the operator.
Duration of comparator- A duration of 5-15 minutes with cotton rolls and single visit treatment
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Primary Outcome(s)
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•Evaluation of the chair side time required for dental treatment using SapDent and conventional cotton rolls.
•Evaluation of the frequency of absorbents pads changed during dental treatment
•Evaluation of the need of saliva ejectors isolation technique in conjugant with absorbent pads during dental treatment
Timepoint: 1 month
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Secondary Outcome(s)
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• Evaluation of the acceptance of SapDent and conventional cotton rolls by children during dental treatment
• Evaluation of the acceptance of SapDent and conventional cotton rolls by operator during dental treatment
Timepoint: 1 month
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Source(s) of Monetary Support
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Government Dental College and Hospital Nagpur
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Ethics review
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Status: Approved
Approval date: 22/09/2022
Contact:
Government Dental College and Hospital Nagpur
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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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URL:
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