Condition category
Oral Health
Date applied
22/12/2011
Date assigned
25/01/2012
Last edited
21/06/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Prof Martin Hobdell

ORCID ID

Contact details

Research Department of Epidemiology and Public Health
University College London
1-19 Torrington Place
London
WC1E 6BT
United Kingdom
+44 (0)20 7679 5636
m.hobdell@ucl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Testing 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’

Acronym

Study hypothesis

Seriously 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

Kinaadman Research Center, Xavier University (Philippines), 4 April 2008

Study design

Randomized wait - list control parallel stratified cluster clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Dental caries, dental decay

Intervention

Group 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 type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Changes in height, weight and quality of life scores in study subjects

Secondary outcome measures

1. 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 trial start date

01/05/2009

Overall trial end date

30/03/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. 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

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

Total subjects 200: 100 in each group

Participant exclusion criteria

1. Children with high caries levels, but no pulpal involvement
2. Children with systemic medical conditions and infectious diseases (e.g. active tuberculosis infection)

Recruitment start date

01/05/2009

Recruitment end date

30/03/2010

Locations

Countries of recruitment

Philippines

Trial participating centre

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

Sponsor information

Organisation

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

Sponsor details

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

Sponsor type

Research organisation

Website

http://www.fdicongress.org/

Funders

Funder type

Research organisation

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22938147
2. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23731717

Publication citations

  1. Results

    Monse B, Duijster D, Sheiham A, Grijalva-Eternod CS, van Palenstein Helderman W, Hobdell MH, The effects of extraction of pulpally involved primary teeth on weight, height and BMI in underweight Filipino children. A cluster randomized clinical trial., BMC Public Health, 2012, 12, 725, doi: 10.1186/1471-2458-12-725.

  2. Results

    Duijster D, Sheiham A, Hobdell MH, Itchon G, Monse B, Associations between oral health-related impacts and rate of weight gain after extraction of pulpally involved teeth in underweight preschool Filipino children., BMC Public Health, 2013, 13, 533, doi: 10.1186/1471-2458-13-533.

Additional files

Editorial Notes