Dental PlaqueNCT01854502
Family-based Counseling Models for Young Children
A study testing Oral hygiene and fluoride use and Diet and use of xylitol in people with Dental Plaque and Dental Caries, run by University of Turku at 1 site in Finland.
Trial summary
The purpose of this study is to compare the effects of two new family-based oral health promotion programs with the routine program in use earlier in Vantaa public dental service. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Dental Plaque, Dental Caries, Behaviorial Habits
- What is being tested?
- Oral hygiene and fluoride use and Diet and use of xylitol
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 804 participants
- Where
- 1 siteFinland
- Study dates
- Jan 2008to Dec 2011
- Phase
- Interventional
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- first born children born in 2008
Who cannot join
- not first born children
Trial locations and contacts
1 site in 1 country.
Finland1 site
Health and social and welfare affairs, oral health
Vantaa, 01510
About this study
Official title: Organizing Family-based Health Promotion for Young Children in Public Dental Service
The purpose of this study is to compare the effects of two new family-based oral health promotion programs with the routine program in use earlier in Vantaa public dental service. The children born in 2008 were followed from their first visit to public dental service at the age of 6-12 months to their dental examination at the age of 2-2½ years. The outcome measures are the colonization of mutans streptococci in dental plaque, dental caries, and the oral health habits of two-year-olds.
Read the detailed description
The investigators hypothesized that the training of the dental professionals involved in children's examinations could improve the quality of the counseling, raise the level of commitment, and give them a new kind of perspective on early childhood oral health counseling. Health promotion programs with clinical guidance aimed also at the parents themselves might commit the families to maintain their children's good oral health.
All programs (two new and the control program) consisted of the basic elements of oral health counseling for the children. The counseling included regular oral hygiene, i.e. tooth brushing with fluoride-containing toothpaste twice a day, advice of a healthy diet with proper timing and composition of meals avoiding sugary snacks, and to use xylitol products on regular basis. Additionally, in the program of oral hygiene and fluoride, the parents were given counseling on how to brush their own teeth with fluoride-containing toothpaste and clean between them. In the program of diet and xylitol parent was asked to fill in one-day diary of his or her own diet in the waiting room, and the dental professional pointed out the frequency of meals and snacks, as well as suggested the use of xylitol 5 grams per day.
The children, accompanied by their parents, were clinically examined in various health clinics of the Vantaa public dental service. At the regular two-year visit, the dental hygienists and in-service trained dental nurses tested the children for mutans streptococci in plaque. The transtheoretical model and the motivational interviewing were introduced to the dental hygienists and in-service trained dental nurses to use in preventive counseling.
The results of this study will be published in three articles.
- Conditions
- Dental Plaque, Dental Caries, Behaviorial Habits
- Being tested
- Oral hygiene and fluoride use, Diet and use of xylitol
- Keywords
- Young children, counseling, fluoride, xylitol
- Medical subject headings
- Dental Plaque, Dental Caries, Habits
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral hygiene and fluoride useBehavioural
Parents were given instructions how to brush and clean between teeth and to use fluoride toothpaste two times a day.
Diet and use of xylitolBehavioural
Parents were asked to fill in one-day diaries of their own diet in the waiting room. The dental professional pointed out the frequency of meals and snacks, as well as suggested the timing of xylitol products.
| Study group | Role | What they receive |
|---|---|---|
| Oral hygiene and fluoride use | Experimental | Parents of young children were given counseling of their own oral hygiene and the use of fluoride on their child's visit to public dental service. The child was given multi-faceted counseling for good oral health habits. Receives: Behavioral: Oral hygiene and fluoride use |
| Control | No intervention | Control, The parents were not given any intervention on their child's visit to public dental service. The child was given multi-faceted counseling for good oral health habits. |
| Diet and use of xylitol | Experimental | Parents of young children were given counseling of their own diet and the use of xylitol on their child's visit to public dental service. The child was given multi-faceted counseling for good oral health habits. Receives: Behavioral: Diet and use of xylitol |
What is being measured
The primary outcome is the main question the study is designed to answer.
The colonization of mutans streptococci bacteria
The children were tested for the amount of mutans streptococci bacteria in their dental plaque at the age of 2 years. The recommended age for testing was 2-2.5 years, and the inclusion limits 2 years and 3 years.
Measured: At the age of 2 years
Secondary outcomes (1)
Dental caries
At the age of two years, the children, accompanied by their parents, were clinically examined in the Vantaa PDS. The dental hygienists and in-service trained dental nurses that were working in each clinic performed the examinations by a mirror using the WHO criteria of the electronic patient database. The dental professionals were not blinded to the group of the child. The information from the clinical examinations, including the number of decayed teeth or teeth with distinct visual changes in enamel, was recorded on the database. No missed or filled teeth were found.
Measured: at the age of two
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2013 (estimated)
- Study startJan 2008
- Primary completionSep 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Dental PlaqueStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 804 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turku
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Irma Arpalahti, University of Turku
- Investigators
- Kaisu Pienihäkkinen, docent, Study director, University of Turku
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01854502
- Sponsor's protocol ID
- IArpalahti2008
- Status last verified
- May 2017
- First submitted
- 3 May 2013
- Last updated
- 8 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: The individual participant data is not planned to be shared with other researchers, it will be destroyed after the study.
Publications
Arpalahti I, Jarvinen M, Suni J, Pienihakkinen K. Acceptance of oral health promotion programmes by dental hygienists and dental nurses in public dental service. Int J Dent Hyg. 2012 Feb;10(1):46-53. doi: 10.1111/j.1601-5037.2011.00517.x. Epub 2011 Jun 23.
PubMed 21699653Arpalahti I, Tolvanen M, Pienihakkinen K. Comparing health promotion programs in public dental service of vantaa, Finland: a clinical trial in 6-36-month-old children. Int J Dent. 2013;2013:757938. doi: 10.1155/2013/757938. Epub 2013 Nov 18.
PubMed 24348559Arpalahti I, Jarvinen M, Kommonen HM, Tolvanen M, Pienihakkinen K. Parental Opinions on Children's Oral Health Counselling and Readiness to Change Health Habits. Oral Health Prev Dent. 2016;14(6):535-545. doi: 10.3290/j.ohpd.a37139.
PubMed 27957564Arpalahti I, Hanninen K, Tolvanen M, Varrela J, Rice DP. The effect of early childhood non-nutritive sucking behavior including pacifiers on malocclusion: a randomized controlled trial. Eur J Orthod. 2024 Oct 1;46(5):cjae024. doi: 10.1093/ejo/cjae024.
PubMed 39119981
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Organizing Family-based Health Promotion for Young Children in Public Dental Service
- ClinicalTrials.gov ID
- NCT01854502
- Acronym / sponsor ID
- IArpalahti2008
- Conditions
- Dental Plaque, Dental Caries, Behaviorial Habits
- Keywords
- Young children, counseling, fluoride, xylitol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 804 participants (actual)
- Lead sponsor
- University of TurkuUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Sep 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 15 May 2013 (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 purpose of this study is to compare the effects of two new family-based oral health promotion programs with the routine program in use earlier in Vantaa public dental service. The children born in 2008 were followed from their first visit to public dental service at the age of 6-12 months to their dental examination at the age of 2-2½ years. The outcome measures are the colonization of mutans streptococci in dental plaque, dental caries, and the oral health habits of two-year-olds.
Detailed description
The investigators hypothesized that the training of the dental professionals involved in children's examinations could improve the quality of the counseling, raise the level of commitment, and give them a new kind of perspective on early childhood oral health counseling. Health promotion programs with clinical guidance aimed also at the parents themselves might commit the families to maintain their children's good oral health.
All programs (two new and the control program) consisted of the basic elements of oral health counseling for the children. The counseling included regular oral hygiene, i.e. tooth brushing with fluoride-containing toothpaste twice a day, advice of a healthy diet with proper timing and composition of meals avoiding sugary snacks, and to use xylitol products on regular basis. Additionally, in the program of oral hygiene and fluoride, the parents were given counseling on how to brush their own teeth with fluoride-containing toothpaste and clean between them. In the program of diet and xylitol parent was asked to fill in one-day diary of his or her own diet in the waiting room, and the dental professional pointed out the frequency of meals and snacks, as well as suggested the use of xylitol 5 grams per day.
The children, accompanied by their parents, were clinically examined in various health clinics of the Vantaa public dental service. At the regular two-year visit, the dental hygienists and in-service trained dental nurses tested the children for mutans streptococci in plaque. The transtheoretical model and the motivational interviewing were introduced to the dental hygienists and in-service trained dental nurses to use in preventive counseling.
The results of this study will be published in three articles.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Oral hygiene and fluoride use | Experimental | Behavioral: Oral hygiene and fluoride useParents of young children were given counseling of their own oral hygiene and the use of fluoride on their child's visit to public dental service. The child was given multi-faceted counseling for good oral health habits. |
| Control | No intervention | –Control, The parents were not given any intervention on their child's visit to public dental service. The child was given multi-faceted counseling for good oral health habits. |
| Diet and use of xylitol | Experimental | Behavioral: Diet and use of xylitolParents of young children were given counseling of their own diet and the use of xylitol on their child's visit to public dental service. The child was given multi-faceted counseling for good oral health habits. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- first born children born in 2008
Key exclusion criteria (1 listed)
- not first born children
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 |
|---|---|---|
| Oral hygiene and fluoride useParents were given instructions how to brush and clean between teeth and to use fluoride toothpaste two times a day. | Behavioural | Oral hygiene and fluoride use |
| Diet and use of xylitolParents were asked to fill in one-day diaries of their own diet in the waiting room. The dental professional pointed out the frequency of meals and snacks, as well as suggested the timing of xylitol products. | Behavioural | Diet and use of xylitol |
Primary outcome
The colonization of mutans streptococci bacteria
Time frame: At the age of 2 years
The children were tested for the amount of mutans streptococci bacteria in their dental plaque at the age of 2 years. The recommended age for testing was 2-2.5 years, and the inclusion limits 2 years and 3 years.
1 secondary outcome
Dental caries
Time frame: at the age of two
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 8 May 2017.
- Results publication: PubMed 21699653Arpalahti I, Jarvinen M, Suni J, Pienihakkinen K. Acceptance of oral health promotion programmes by dental hygienists and dental nurses in public dental service. Int J Dent Hyg. 2012 Feb;10(1):46-53. doi: 10.1111/j.1601-5037.2011.00517.x. Epub 2011 Jun 23.
- Results publication: PubMed 24348559Arpalahti I, Tolvanen M, Pienihakkinen K. Comparing health promotion programs in public dental service of vantaa, Finland: a clinical trial in 6-36-month-old children. Int J Dent. 2013;2013:757938. doi: 10.1155/2013/757938. Epub 2013 Nov 18.
- Results publication: PubMed 27957564Arpalahti I, Jarvinen M, Kommonen HM, Tolvanen M, Pienihakkinen K. Parental Opinions on Children's Oral Health Counselling and Readiness to Change Health Habits. Oral Health Prev Dent. 2016;14(6):535-545. doi: 10.3290/j.ohpd.a37139.
- Derived from this study: PubMed 39119981Arpalahti I, Hanninen K, Tolvanen M, Varrela J, Rice DP. The effect of early childhood non-nutritive sucking behavior including pacifiers on malocclusion: a randomized controlled trial. Eur J Orthod. 2024 Oct 1;46(5):cjae024. doi: 10.1093/ejo/cjae024.
- Doctoral thesis (article-based)Link provided by the sponsor.
- Individual participant dataSharing planned: No. The individual participant data is not planned to be shared with other researchers, it will be destroyed after the study.
Related trials for Dental Plaque
Active, not recruitingPhase 3
A Study to Assess the Efficacy of Two Brushing Regimens in the Reduction of Established Dental Plaque and Gingivitis
Plaque, Gingivitis
Not yet recruiting
Effectiveness of Personalized Digital Oral Health Intervention in Patients With Fixed Orthodontic Appliances.
Oral Hygiene in Patients With Fixed Orthodontic Appliances, Dental Plaque
Not yet recruiting
Effect of Xylitol- Versus Erythritol-Sweetened Mints on Plaque ATP-Bioluminescence Readings
Dental Caries, Dental Plaque
Not yet recruitingObservational study
Plaque and Bleeding on Probing Around Implants Supporting Fixed Full-Arch Dental Prostheses
Peri-Implant Health
Not yet recruiting
Effectiveness of Oil Pulling Using Oils in Comparison With Mouthwash for Gingivitis
Gingivitis
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.
Kaisu Pienihäkkinen, docent study director
University of Turku
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral hygiene and fluoride use and Diet and use of xylitol in people with Dental Plaque and Dental Caries, run by University of Turku at 1 site in Finland.
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 8 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does the primary outcome measure?
The colonization of mutans streptococci bacteria (time frame: At the age of 2 years). 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 NCT01854502, which also lists 4 linked publications.
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 8 May 2017.