Effect of Dental Treatment on Children's Growth

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01243866
Recruitment Status : Completed
First Posted : November 19, 2010
Last Update Posted : November 19, 2010
Information provided by:
King Fahad Armed Forces Hospital

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.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Dental Treatment on Children's Growth
Study Start Date : February 2007
Actual Primary Completion Date : January 2008
Actual Study Completion Date : January 2008

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U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Children's height and weight (HAZ,WAZ and BAZ) [ Time Frame: 6 months ]
    children's height and weight were measured pre and 6 months post dental treatment.

Secondary Outcome Measures :
  1. Quality of life (pain, sepsis, satisfaction and appetite) [ Time Frame: 6 months ]
    specific general and oral quality of life health measures were examined before and after dental treatment

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Ages Eligible for Study:   72 Months to 95 Months   (Child)
Sexes Eligible for Study:   All

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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01243866

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Dr Hiba Alkarimi, King Fahad Armed Forces Hospital Identifier: NCT01243866     History of Changes
Other Study ID Numbers: MD109
First Posted: November 19, 2010    Key Record Dates
Last Update Posted: November 19, 2010
Last Verified: January 2008

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