Back to resultsEffect of Dental Treatment on Children's Growth
Primary Purpose
Dental Decay
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
comprehensive dental treatment
Only emergency dental treatment
Sponsored by
About this trial
This is an interventional treatment trial for Dental Decay
Eligibility Criteria
Inclusion Criteria:
Having dental caries with at least 2 teeth with pulpal involvement.
Exclusion Criteria:
- Children with illness known to adversely affect growth.
- Children who required urgent dental treatment.
- Children on regular nutritional supplements.
- Anaemic children with Hb levels lower than 11.0 g/dl
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Early treatment
Regualr treatment
Arm Description
comprehensive dental treatment
Regular treatment consisted of children who would be on a waiting list for regular dental treatment at KFAFH for at least 8 months
Outcomes
Primary Outcome Measures
Children's height and weight (HAZ,WAZ and BAZ)
children's height and weight were measured pre and 6 months post dental treatment.
Secondary Outcome Measures
Quality of life (pain, sepsis, satisfaction and appetite)
specific general and oral quality of life health measures were examined before and after dental treatment
Full Information
NCT ID
NCT01243866
First Posted
November 18, 2010
Last Updated
November 18, 2010
Sponsor
King Fahad Armed Forces Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01243866
Brief Title
Effect of Dental Treatment on Children's Growth
Official Title
Effect of Dental Treatment on Children's Growth
Study Type
Interventional
2. Study Status
Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
January 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
King Fahad Armed Forces Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Severe dental decay affects children physically, emotionally, socially and thereby impacts on their quality of life. Evidence from developed countries showed that children with severe dental decay weighed less than their peers and following dental treatment children's growth and quality of life improved. This suggests that treatment of severe dental decay may enhance growth and wellbeing. A study was carried out in Saudi to test that hypothesis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Decay
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
86 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Early treatment
Arm Type
Experimental
Arm Description
comprehensive dental treatment
Arm Title
Regualr treatment
Arm Type
No Intervention
Arm Description
Regular treatment consisted of children who would be on a waiting list for regular dental treatment at KFAFH for at least 8 months
Intervention Type
Other
Intervention Name(s)
comprehensive dental treatment
Intervention Description
Early treatment children were scheduled for comprehensive dental treatment over a 2-month period (from May to June 2007). All test children had their last dental treatment visit within the last 2 weeks of the second treatment month. The follow-up survey was scheduled for each child to be approximately 6-month after their dental last visit. This step was very important to make sure that all children were examined at exactly the same interval between end of treatment and when re-examined at the follow-up examination.
Intervention Type
Other
Intervention Name(s)
Only emergency dental treatment
Intervention Description
Regular treatment did not receive any dental treatment in the period when the early children were treated unless they had toothache or dental infection. In that case they were treated for the pain but did not have comprehensive dental treatment
Primary Outcome Measure Information:
Title
Children's height and weight (HAZ,WAZ and BAZ)
Description
children's height and weight were measured pre and 6 months post dental treatment.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Quality of life (pain, sepsis, satisfaction and appetite)
Description
specific general and oral quality of life health measures were examined before and after dental treatment
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
72 Months
Maximum Age & Unit of Time
95 Months
Eligibility Criteria
Inclusion Criteria:
Having dental caries with at least 2 teeth with pulpal involvement.
Exclusion Criteria:
Children with illness known to adversely affect growth.
Children who required urgent dental treatment.
Children on regular nutritional supplements.
Anaemic children with Hb levels lower than 11.0 g/dl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hiba A Alkarimi, PhD
Organizational Affiliation
KFAFH
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
22928903
Citation
Alkarimi HA, Watt RG, Pikhart H, Jawadi AH, Sheiham A, Tsakos G. Impact of treating dental caries on schoolchildren's anthropometric, dental, satisfaction and appetite outcomes: a randomized controlled trial. BMC Public Health. 2012 Aug 29;12:706. doi: 10.1186/1471-2458-12-706.
Results Reference
derived
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Effect of Dental Treatment on Children's Growth
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