The effect of extracting badly decayed baby teeth from young underweight Filipino children on the children’s weight and height

ISRCTN ISRCTN90779069
DOI https://doi.org/10.1186/ISRCTN90779069
Secondary identifying numbers N/A
Submission date
22/12/2011
Registration date
25/01/2012
Last edited
21/06/2013
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Oral Health
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
In many low- and middle-income countries, the proportion of untreated dental decay of the baby teeth in young children is high. In a national study in the Philippines, dental decay was universal in 6-year-old children. On average they had over eight baby teeth that were either decayed, or had been extracted or filled because of decay. in over 84% of cases the decay was advanced and had reached the pulp causing infection or abscesses in bone and tissues outside the tooth - this is what ‘severely decayed teeth’ means. Poor oral health in children is linked to underweight and failure to thrive. In a previous Philippines National Oral Health Survey children needing multiple extractions of severely decayed teeth had significantly lower body weights than children with no decay. Complete dental rehabilitation of underweight children with severe dental decay has been shown to be linked to an increased rate of weight gain that may have been related to eliminating dental pain and infection that negatively affected children’s ability to eat and sleep. The objective of this study was to measure if extraction of severely decayed baby teeth affected weight and height in underweight preschool Filipino children, using a randomised controlled trial design (children were randomly allocated to one of two groups).

Who can participate?
All children included in the study were attending day care centres in villages in the Provinces of Cagayan de Oro and Misamis Oriental, Northern Mindanao, Philippines. Children aged between 4 years and 6 months to 5 years and 8 months participated. They were all underweight and had severe dental decay in one or more baby teeth. All children were tested for active tuberculosis infection. Children testing positively were not included, as were children with other medical conditions and infections.


What does the study involve?
Screening visit: All carers, in selected Barangays, were invited to bring their children to a screening session. Trained interviewers obtained basic information about the children such as date of birth, general health and oral problems using a structured interview. Children’s weight and height were measured and their mouths examined. Underweight children meeting the inclusion criteria were invited to join the study.

Treatment visit: Immediately prior to treatment weight and height were again recorded and a blood sample taken to test for anaemia. All severely decayed teeth were extracted using local anaesthesia and other less seriously decayed teeth were treated with silver-diamine-fluoride which slows progression of decay. The children’s carers were interviewed to provide information on the impact that dental problems had on their children’s daily lives.

Follow-up visit 1: Four months later Group B children received the identical treatment as Group A children had received four months earlier. Group A children had weight and height measured and their carers were interviewed.

Follow-up visit 2: All children had weight and height measured and their carers were interviewed as previously. Both Group A and Group B children also had a second blood sample taken to assess anaemia.

What are the possible benefits and risks in taking part?
The children benefit from receiving dental treatment that they would not otherwise be able to access. The children will have greatly reduced dental pain and be able to eat and sleep better. Carers too will enjoy improved peace-of-mind knowing that their children have greatly reduced pain, eat and sleep better.
The risks of high quality dental extractions in young children under local anaesthesia are rare and very minimal, should they occur. Many thousands of dental extractions are carried out around the world each year with very few complications. Complications are infrequent and easily dealt with, resulting in no lasting harm.

Where is the study run from?
Locally in Cagayan de Oro

When is the study and how long is it expected to run for?
The study started in May 2009 and ended in April 2010.

Who is funding the study?
This study was supported by a grant from FDI World Dental-Education.

Who is the main contact?
Professor Martin Hobdell
m.hobdell@ucl.ac.uk

Contact information

Prof Martin Hobdell
Scientific

Research Department of Epidemiology and Public Health
University College London
1-19 Torrington Place
London
WC1E 6BT
United Kingdom

Phone +44 (0)20 7679 5636
Email m.hobdell@ucl.ac.uk

Study information

Study designRandomized wait - list control parallel stratified cluster clinical trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleTesting the effects of tooth extraction in preschool underweight Filipino children with severe dental decay followed by increased velocity of weight gain and improvement in ‘oral health related quality of life’
Study objectivesSeriously decayed teeth cause pain and make eating and sleeping difficult. A lack of sleep and poor eating causes, among other things, young children to be underweight and not grow properly. It can have serious lifelong effects on their mental and physical development. This study measures the effects on the subsequent growth (height) and weight of young children after they had their seriously decayed (those with pulpal infection) baby teeth extracted.
Ethics approval(s)Kinaadman Research Center, Xavier University (Philippines), 4 April 2008
Health condition(s) or problem(s) studiedDental caries, dental decay
InterventionGroup A: Intervention group
Group B : Wait-list control

Immediately prior to treatment weight and height were recorded and a blood sample taken to test for anaemia. The intervention consisted of extracting all pulpally involved teeth under local anaesthesia, and painting other carious teeth with silver-diamine-fluoride to arrest the decay. The children’s carers were interviewed to provide information on the impact that dental problems had on their children’s daily lives.


Both Groups A and B received the same treatment the only difference was that Group B received treatment 4 months after Group A.
Intervention typeOther
Primary outcome measureChanges in height, weight and quality of life scores in study subjects
Secondary outcome measures1. Changes in Z-scores of height and weight between Group A and Group B
2. Changes in eating, sleeping, and other quality of life impairments
3. Changes in haemoglobin levels
Overall study start date01/05/2009
Completion date30/03/2010

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit4 Years
Upper age limit5 Years
SexBoth
Target number of participantsTotal subjects 200: 100 in each group
Key inclusion criteria1. Severe dental decay i.e. one or more teeth with dental pulp involvement irrespective of number of teeth decayed
2. Body weight below normal (underweight) according to age, using National Center for Health Statistics (NCHS) reference standards
3. Children aged between 4 years and 6 months to 5 years and 8 months
Key exclusion criteria1. Children with high caries levels, but no pulpal involvement
2. Children with systemic medical conditions and infectious diseases (e.g. active tuberculosis infection)
Date of first enrolment01/05/2009
Date of final enrolment30/03/2010

Locations

Countries of recruitment

  • England
  • Philippines
  • United Kingdom

Study participating centre

Research Department of Epidemiology and Public Health
London
WC1E 6BT
United Kingdom

Sponsor information

World Dental Federation (Fédération Dentaire Internationale) (FDI) (Switzerland)
Research organisation

Tour De Cointrin
Avenue Louis Casai 84
Case Postale 3
Geneva
1216
Switzerland

Website http://www.fdicongress.org/
ROR logo "ROR" https://ror.org/049htfh25

Funders

Funder type

Research organisation

World Dental Federation (Fédération Dentaire Internationale) (FDI) (Switzerland)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 31/08/2012 Yes No
Results article results 03/06/2013 Yes No