Health BehaviorNCT01272544
Oral Health of Individuals Who Attended a Mother-child Dental Care Program - Longitudinal Study
An observational study of Health Behavior, run by Universidade Federal do Piauí.
Trial summary
The aim of this longitudinal study was to assess the oral health of individuals attending a mother-child dental care program (PPPWB). The mean DMFT and GBI in the second phase and the control group were 0.75 and 6.75, 1.47 and 10.74, respectively. Read more about this study
- Who is it for?
- Ages 9 to 13 years
- Conditions the study is for
- Health Behavior
- How many people
- 278 participants
- Where
- No sites listed yet
- Study dates
- Sep 2009to May 2010
- Phase
- Observational
- 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 9 to 13 years
- All sexes
- No healthy volunteers
- Child
Study population: Letters were sent to 343 of the examined children, inviting the guardians to take their children for an oral health assessment at the children's dental clinic at UFPI. The number of children that returned for an examination was 139, and these individuals comprised the experimental group. Control Group After assessing the characteristics of the experimental group, the control group was determined and consisted of 139 individuals (93 females and 46 males) who were paired to the experimental group according to their socio-demographic characteristics and age but who had not attended the PPPWB. The study hypothesis is that individuals who attended the PPPWB have better oral health than those who did not attend it.
Who may be able to join
- Children who participated to the program
Who cannot join
- children who did not participate
About this study
The aim of this longitudinal study was to assess the oral health of individuals attending a mother-child dental care program (PPPWB). The mean DMFT and GBI in the second phase and the control group were 0.75 and 6.75, 1.47 and 10.74, respectively. It was concluded that the individuals who attended the PPPWB had better oral health status than the control group. When the two phases of the study were compared, it was noted that the individuals in the second phase had better oral health, although they had a higher score for gingival bleeding.
Read the detailed description
The aim of this longitudinal study was to assess the oral health of individuals attending a mother-child dental care program (PPPWB). Letters were sent to the 343 children who were examined in phase 1. One hundred and thirty nine individuals returned for the oral examination - experimental group (40.5%). The control group consisted of 139 individuals who did not receive dental care from the PPPWB. These individuals were paired to the experimental group according to their age and socio-demographic characteristics. Gingival bleeding (GBI) and DMFT indices were used in order to determine the children's oral health status. The mean DMFT and GBI in the second phase and the control group were 0.75 and 6.75, 1.47 and 10.74, respectively. It was concluded that the individuals who attended the PPPWB had better oral health status than the control group. When the two phases of the study were compared, it was noted that the individuals in the second phase had better oral health, although they had a higher score for gingival bleeding.
- Conditions
- Health Behavior
- Keywords
- Dental caries, Epidemiology, Gingivitis, Oral health
- Medical subject headings
- Health Behavior, Dental Caries, Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| participation in a dental health program | Group 1 - children who participated to a dental health program Group 2 - children who did not participate to dental health program | |
| participation in a preventive program | Group 1 - children who participated to the preventive program Group 2 - children who did not participate |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2011 (estimated)
- Study startSep 2009
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health BehaviorStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 278 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Piauí
- Sponsor type
- University, hospital or other
- Investigators
- Lucia D Moura, PhD, Study chair, Universidade Federal do PiauiCacilda C Lima, DDS, Principal investigator, Universidade Federal do PiauiMarcoeli S Moura, PhD, Study director, Universidade Federal do PiauiJosilda F Martins, PhD, Study director, Universidade Federal do PiauiMarina M Lima, PhD, Study director, Universidade Federal do Piaui
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01272544
- Sponsor's protocol ID
- mouraiso
- Status last verified
- Sep 2009
- First submitted
- 6 Jan 2011
- Last updated
- 7 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Health of Individuals Who Attended a Mother-child Dental Care Program - Longitudinal Study
- ClinicalTrials.gov ID
- NCT01272544
- Acronym / sponsor ID
- mouraiso
- Conditions
- Health Behavior
- Keywords
- Dental caries, Epidemiology, Gingivitis, Oral health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 278 participants (actual)
- Lead sponsor
- Universidade Federal do PiauíUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 7 Jan 2011 (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.
The aim of this longitudinal study was to assess the oral health of individuals attending a mother-child dental care program (PPPWB). The mean DMFT and GBI in the second phase and the control group were 0.75 and 6.75, 1.47 and 10.74, respectively. It was concluded that the individuals who attended the PPPWB had better oral health status than the control group. When the two phases of the study were compared, it was noted that the individuals in the second phase had better oral health, although they had a higher score for gingival bleeding.
Detailed description
The aim of this longitudinal study was to assess the oral health of individuals attending a mother-child dental care program (PPPWB). Letters were sent to the 343 children who were examined in phase 1. One hundred and thirty nine individuals returned for the oral examination - experimental group (40.5%). The control group consisted of 139 individuals who did not receive dental care from the PPPWB. These individuals were paired to the experimental group according to their age and socio-demographic characteristics. Gingival bleeding (GBI) and DMFT indices were used in order to determine the children's oral health status. The mean DMFT and GBI in the second phase and the control group were 0.75 and 6.75, 1.47 and 10.74, respectively. It was concluded that the individuals who attended the PPPWB had better oral health status than the control group. When the two phases of the study were compared, it was noted that the individuals in the second phase had better oral health, although they had a higher score for gingival bleeding.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| participation in a dental health program | – | –Group 1 - children who participated to a dental health program Group 2 - children who did not participate to dental health program |
| participation in a preventive program | – | –Group 1 - children who participated to the preventive program Group 2 - children who did not participate |
Who may qualify
- Ages
- 9 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Letters were sent to 343 of the examined children, inviting the guardians to take their children for an oral health assessment at the children's dental clinic at UFPI. The number of children that returned for an examination was 139, and these individuals comprised the experimental group. Control Group After assessing the characteristics of the experimental group, the control group was determined and consisted of 139 individuals (93 females and 46 males) who were paired to the experimental group according to their socio-demographic characteristics and age but who had not attended the PPPWB. The study hypothesis is that individuals who attended the PPPWB have better oral health than those who did not attend it.
Key inclusion criteria (1 listed)
- Children who participated to the program
Key exclusion criteria (1 listed)
- children who did not participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 7 Jan 2011.
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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.
Lucia D Moura, PhD study chair
Universidade Federal do Piaui
Cacilda C Lima, DDS principal investigator
Universidade Federal do Piaui
Marcoeli S Moura, PhD study director
Universidade Federal do Piaui
Questions about this trial
What is this clinical trial studying?
An observational study of Health Behavior, run by Universidade Federal do Piauí.
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 1 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 7 Jan 2011. 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.
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.
Where can I read the original study information?
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 7 Jan 2011.