NCT01243866

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Feb 2007

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

November 18, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 19, 2010

Completed
Last Updated

November 19, 2010

Status Verified

January 1, 2008

Enrollment Period

11 months

First QC Date

November 18, 2010

Last Update Submit

November 18, 2010

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Quality of life (pain, sepsis, satisfaction and appetite)

    6 months

Study Arms (2)

Early treatment

EXPERIMENTAL

comprehensive dental treatment

Other: comprehensive dental treatment

Regualr treatment

NO INTERVENTION

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

Interventions

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.

Early 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

Regualr treatment

Eligibility Criteria

Age72 Months - 95 Months
Sexall
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Officials

  • Hiba A Alkarimi, PhD

    KFAFH

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

November 18, 2010

First Posted

November 19, 2010

Study Start

February 1, 2007

Primary Completion

January 1, 2008

Study Completion

January 1, 2008

Last Updated

November 19, 2010

Record last verified: 2008-01