Effect of Dental Treatment on Children's Growth

This study has been completed.
Sponsor:
Information provided by:
King Fahad Armed Forces Hospital
ClinicalTrials.gov Identifier:
NCT01243866
First received: November 18, 2010
Last updated: NA
Last verified: January 2008
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Dental Decay
Other: comprehensive dental treatment
Other: Only emergency dental treatment
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Dental Treatment on Children's Growth

Resource links provided by NLM:


Further study details as provided by King Fahad Armed Forces Hospital:

Primary Outcome Measures:
  • Children's height and weight (HAZ,WAZ and BAZ) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    specific general and oral quality of life health measures were examined before and after dental treatment


Enrollment: 86
Study Start Date: February 2007
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Early treatment
comprehensive dental treatment
Other: comprehensive dental treatment
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.
No Intervention: Regualr treatment
Regular treatment consisted of children who would be on a waiting list for regular dental treatment at KFAFH for at least 8 months
Other: Only emergency dental treatment
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

  Eligibility

Ages Eligible for Study:   72 Months to 95 Months
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

Having dental caries with at least 2 teeth with pulpal involvement.

Exclusion Criteria:

  1. Children with illness known to adversely affect growth.
  2. Children who required urgent dental treatment.
  3. Children on regular nutritional supplements.
  4. Anaemic children with Hb levels lower than 11.0 g/dl
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01243866

Sponsors and Collaborators
King Fahad Armed Forces Hospital
Investigators
Study Director: Hiba A Alkarimi, PhD KFAFH
  More Information

No publications provided by King Fahad Armed Forces Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr Hiba Alkarimi, King Fahad Armed Forces Hospital
ClinicalTrials.gov Identifier: NCT01243866     History of Changes
Other Study ID Numbers: MD109
Study First Received: November 18, 2010
Last Updated: November 18, 2010
Health Authority: Saudi Arabia: Ethics Committee

Additional relevant MeSH terms:
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on July 28, 2014