Effect of Dental Treatment on Children's Growth

Dental Decay Clinical Trial

Official title:

Effect of Dental Treatment on Children's Growth

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01243866
• Other study ID #: MD109
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: November 18, 2010
• Last updated: November 18, 2010
• Start date: February 2007
• Est. completion date: January 2008

Study information

• Verified date: January 2008
• Source: King Fahad Armed Forces Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Saudi Arabia: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Gender: Both
• Age group: 72 Months to 95 Months

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dental Decay

Intervention

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.
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
King Fahad Armed Forces Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Children's height and weight (HAZ,WAZ and BAZ)	children's height and weight were measured pre and 6 months post dental treatment.	6 months	No
Secondary	Quality of life (pain, sepsis, satisfaction and appetite)	specific general and oral quality of life health measures were examined before and after dental treatment	6 months	No