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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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ISRCTN |
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Last refreshed on:
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3 March 2020 |
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Main ID: |
ISRCTN31416107 |
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Date of registration:
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17/04/2018 |
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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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Dental Scaling and Root Planning Improve Allergies
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Scientific title:
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Effect of Comprehensive Six Months Dental Scaling and Root Planning To Improve Biomolecular Markers of Atopy in Gingivitis Children with House Dust Mite Allergy |
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Date of first enrolment:
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31/01/2017 |
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Target sample size:
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10 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN31416107 |
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Study type:
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Interventional |
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Study design:
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Investigator-initiated randomized non-blinded placebo-controlled trial with two-group pretest and repeated posttest superiority-group experimental design (Treatment)
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Phase:
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Not Applicable
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Countries of recruitment
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Indonesia
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Sindy
Nelwan |
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Address:
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Jalan Mayjen Prof. Dr. Moestopo 47
60135
Surabaya
Indonesia |
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Telephone:
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+62 811 346979 |
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Email:
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sindy-c-n@fkg.unair.ac.id |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria:
1. Children aged 6-16 years of any gender and ethnicity
2. Diagnosed with HDM allergies by positive skin-prick test
3. Diagnosed with gingivitis by >2 plaque index according to Silness-Löe criteria
4. High baseline IgE titer (>90 pg/ml), suggesting a positive childhood allergic potency
5. Understand and able to cooperate to the research protocol
6. Parents give voluntary, signed written consent in accordance with our institutional policies
Exclusion criteria:
1. Taking any antihistamines or steroid which commonly interferes with results of skin-prick within one month
2. Previously experienced any immunotherapy procedures
3. Previously experienced dental scaling and root planning within 6 months
4. Presence of low grade fever due to infections rather than gingivitis
5. Recent blood disorders or congenital abnormalities
6. Any medical conditions that may be harmful if involved in this study
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Periodontitis
Oral Health
Periodontitis
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Intervention(s)
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Participants are randomly allocated to one of two groups. Those in the intervention group receive a comprehensive 6 months dental scaling and root planning treatment program, as well as standard treatment. Scaling and Root Planning is performed by a well-experienced physician from Department of Pediatric Dentistry, Faculty of Dental Medicine Universitas Airlangga - Dr. Soetomo General Hospital, using an ultrasonic scaler. Participants attend a dental session monthly.
Those in the control group receive only standard treatment.
Standard treatment includes toothpaste containing fluoride and triclosan, and monthly consultation with a well-experienced physician.
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Primary Outcome(s)
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IgE is measured from a blood sample at baseline and 6 months
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Secondary Outcome(s)
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IgG4 is measured from a blood sample at baseline and 6 months
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Secondary ID(s)
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20/Panke.KKE/I/2017
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Source(s) of Monetary Support
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Faculty of Dental Medicine Universitas Airlangga
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Ethics review
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Status:
Approval date:
Contact:
Dr. Soetomo General Hospital Ethics Committee for Health Research, 20/01/2017, ref: 20/Panke.KKE/I/2017
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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31/12/2017 |
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URL:
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