Comparison of effectiveness of non-pharmacological and herbal treatments in reducing complications of the primary teeth eruption in children 5 to 15 months
In this clinical study, 450 children between 5 and 15 months old are selected through simple sampling method from health centers in deprived areas of Shiraz. The Inclusion criteria are normal birth weight (≤ 2500 g), fullterm and healthy neonates and children with at least one primary teeth not erupted.The exclusion criteria are children with infectious diseases, syndromic children and children with systemic diseases. Data are collected in four stages: 1. When there are no signs of teeth eruption (first examination session - Selection Session) 2. During the 4 days before the eruption (second session). 3. Eruption day(third session). 4. During the 4 days after the eruption (fourth session)
Intervention groups: 1. Eruption Control: no specific treatment is done and behavioral therapy is used only. 2. Nonpharmacologic treatments: the group is trained with the distribution of pamphlets on primary teeth eruption and potential problems within it. Also to treat symptoms of tooth eruption, nonpharmacologic treatments are suggested, such as using cold-tooth rings, pacifiers freezer, small retailers, gauze or wet towel, massaging the baby's gums with a clean finger or a finger toothbrush for 1 -2 minutes. 3. Herbal treatments: the group is trained with the distribution of pamphlets on primary teeth eruption, Herbal treatments of eruption symptoms are taught to parents such as licorice root for chewing or massaging the gum with the chamomile or olive oil.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201211127402N3
Registration date:2012-11-26, 1391/09/06
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-11-26, 1391/09/06
Registrant information
Name
Mahtab Memarpour
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1626 3192
Email address
memarpour@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2012-12-21, 1391/10/01
Expected recruitment end date
2013-10-23, 1392/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effectiveness of non-pharmacological and herbal treatments in reducing complications of the primary teeth eruption in children 5 to 15 months
Public title
Comparison of non pharmacological methods in reducing complications of the primary teeth eruption
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Normal birth weight (≤ 2500 g); Fullterm and healthy neonates; with at least one primary teeth not erupted.
Exclusion criteria: Children with infectious diseases; Syndromic children; Children with systemic diseases.
Age
From 1 year old to 2 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
450
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
Pediatric Dentistry Department, Faculty of Dentistry, Ghomabad, Ghasrodasht
City
Shiraz
Postal code
Approval date
2012-11-07, 1391/08/17
Ethics committee reference number
CT-91-6317
Health conditions studied
1
Description of health condition studied
Complications of the primary teeth eruption
ICD-10 code
K00.6
ICD-10 code description
Disturbances in tooth eruption
Primary outcomes
1
Description
Fever
Timepoint
Beginning of the research, Fourth day, Eighth day, Eleventh day
Beginning of the research, Fourth day, Eighth day, Eleventh day
Method of measurement
Questionnaires, Physical examination, Observation
4
Description
Diarrhea
Timepoint
Beginning of the research, Fourth day, Eighth day, Eleventh day
Method of measurement
Questionnaires
Secondary outcomes
empty
Intervention groups
1
Description
1. Eruption Control: no specific treatment is done and behavioral therapy is used only.
Category
Behavior
2
Description
2. Nonpharmacologic treatments: the group is trained with the distribution of pamphlets on primary teeth eruption and potential problems within it. Also to treat symptoms of tooth eruption, nonpharmacologic treatments are suggested, such as using cold-tooth rings, pacifiers freezer, small retailers, gauze or wet towel, massaging the baby's gums with a clean finger or a finger toothbrush for 1 -2 minutes
Category
Other
3
Description
3. Herbal treatments: the group is trained with the distribution of pamphlets on primary teeth eruption, Herbal treatments of eruption symptoms are taught to parents such as licorice root for chewing or massaging the gum with the chamomile or olive oil.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Saadi Health Center
Full name of responsible person
Maryam Ostovar
Street address
Neyestan Boulevard, Saadi Street
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Doctor Ali Poust Foroushfard
Street address
Shiraz University of Medical Sciences, Zand Street
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mahtab Memarpour
Position
Associate Professor of Pediatric Dentistry / Faculty
Other areas of specialty/work
Street address
Pediatric Dentistry Department, Faculty of Dentistry, Ghomabad, Ghasrodasht
City
Shiraz
Postal code
Phone
+98 71 1626 3192
Fax
Email
memarpour@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mahtab Memarpour
Position
Associate Professor of Pediatric Dentistry / Faculty
Other areas of specialty/work
Street address
Pediatric Dentistry Department, Faculty of Dentistry, Ghomabad, Ghasrodasht
City
Shiraz
Postal code
Phone
+98 71 1626 3192
Fax
Email
memarpour@sums.c.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mahtab Memarpour
Position
Associate Professor of Pediatric Dentistry / Faculty
Other areas of specialty/work
Street address
Pediatric Dentistry Department, Faculty of Dentistry, Ghomabad, Ghasrodasht
City
Shiraz
Postal code
Phone
+98 71 1626 3192
Fax
Email
memarpour@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)