Dental DecayPhase 1/2NCT01243866
Effect of Dental Treatment on Children's Growth
A Phase 1/2 study testing comprehensive dental treatment and Only emergency dental treatment in people with Dental Decay, run by King Fahad Armed Forces Hospital.
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. Read more about this study
- Who is it for?
- Ages 72 to 95 months
- Conditions the study is for
- Dental Decay
- What is being tested?
- comprehensive dental treatment and Only emergency dental treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- No sites listed yet
- Study dates
- Feb 2007to Jan 2008
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 72 to 95 months
- All sexes
- Child
Who may be able to join
- Having dental caries with at least 2 teeth with pulpal involvement.
Who cannot join
- 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
About this study
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.
- Conditions
- Dental Decay
- Being tested
- comprehensive dental treatment, Only emergency dental treatment
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
comprehensive dental treatmentOther
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 treatmentOther
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
| Study group | Role | What they receive |
|---|---|---|
| Early treatment | Experimental | comprehensive dental treatment Receives: 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 Receives: Other: Only emergency dental treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Children's height and weight (HAZ,WAZ and BAZ)
children's height and weight were measured pre and 6 months post dental treatment.
Measured: 6 months
Secondary outcomes (1)
Quality of life (pain, sepsis, satisfaction and appetite)
specific general and oral quality of life health measures were examined before and after dental treatment
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2010 (estimated)
- Study startFeb 2007
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental DecayStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Fahad Armed Forces Hospital
- Sponsor type
- Other government
- Investigators
- Hiba A Alkarimi, PhD, Study director, KFAFH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01243866
- Sponsor's protocol ID
- MD109
- Status last verified
- Jan 2008
- First submitted
- 18 Nov 2010
- Last updated
- 19 Nov 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 22928903
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dental Treatment on Children's Growth
- ClinicalTrials.gov ID
- NCT01243866
- Acronym / sponsor ID
- MD109
- Conditions
- Dental Decay
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- King Fahad Armed Forces HospitalOther government
- Study start
- Feb 2007
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 19 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early treatment | Experimental | Other: comprehensive dental treatmentcomprehensive dental treatment |
| Regualr treatment | No intervention | Other: Only emergency dental treatmentRegular treatment consisted of children who would be on a waiting list for regular dental treatment at KFAFH for at least 8 months |
Who may qualify
- Ages
- 72 to 95 months
- Sex
- All
- Age groups
- Child
Key inclusion criteria (1 listed)
- Having dental caries with at least 2 teeth with pulpal involvement.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| comprehensive dental treatmentEarly 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. | Other | Early treatment |
| Only emergency dental treatmentRegular 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 | Other | Regualr treatment |
Primary outcome
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.
1 secondary outcome
Quality of life (pain, sepsis, satisfaction and appetite)
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2010.
- Derived from this study: PubMed 22928903Alkarimi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hiba A Alkarimi, PhD study director
KFAFH
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing comprehensive dental treatment and Only emergency dental treatment in people with Dental Decay, run by King Fahad Armed Forces Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Children's height and weight (HAZ,WAZ and BAZ) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01243866, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2010.