Dental Caries and Streptococcus Mutans CountPhase 4NCT02036151
Impact of Maternal Xylitol Consumption on Mutans Sterptococci
A Phase 4 study testing xylitol and fluoride varnish application in people with Dental Caries and Streptococcus Mutans Count, run by King Abdulaziz University at 1 site in Saudi Arabia.
Trial summary
The study was designed to determine whether maternal xylitol consumption through regular chewing of xylitol gums can affect the salivary mutans streptococci (MS), dental caries, and dental plaque levels of their children. Read more about this study
- Who is it for?
- Ages 10 to 36 monthsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries and Streptococcus Mutans Count
- What is being tested?
- xylitol and fluoride varnish application
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Feb 2009to Sep 2011
- Phase
- Phase 4
- 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 10 to 36 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- mothers with high salivary counts (≥ 105)
- mothers having children at least 10 months of age (10-36months) or having a minimal of 8 primary teeth.
Who cannot join
- subjects with systemic disorders or on regular medications
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
King abulaziz University, Dental University Hospital
Jeddah, P.O Box 80209, 21589
About this study
Official title: Impact of Maternal Xylitol Consumption on Mutans Sterptococci ,Plaque and Caries Levels in Children
The study was designed to determine whether maternal xylitol consumption through regular chewing of xylitol gums can affect the salivary mutans streptococci (MS), dental caries, and dental plaque levels of their children.
Read the detailed description
Method: Study sample included 60 mother and child pairs with high salivary mutans streptococcus (MS) levels. Samples were randomly divided into experimental group (30 pairs) and control group (30 pairs). Mothers in the experimental group received xylitol chewing gum treatment three times/day for three months, whereas the controls received fluoride varnish. Both groups received oral hygiene instructions, dietary counseling and restorative treatment. All children were examined after 6, 12 and 18 months from the initiation of the study to assess caries, plaque and salivary mutans streptococcus (MS) levels.
- Being tested
- xylitol, fluoride varnish application
- Keywords
- Xylitol, prevention, Mutans streptococci, caries, plaque, children
- Medical subject headings
- Dental Caries, Plaque, Amyloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
xylitolDrug
Also called Fennobon Oy, Yrittäjäntie, Finneland - chewing, gum, tablet , 1.8g and containing 66% xylitol by weight,
Mothers in the experimental group were instructed to chew 1 pellet of xylitol gum (Fennobon Oy, Yrittäjäntie, Finneland -gum, 3 times ) for a period of 3 months. control mothers did not receive any medications. All mothers received oral hygiene instructions and restorative treatment when needed. Offspring of both the experimental and control groups did not receive any medication and were followed for at 6,12, 18 and 24 month from initiation of mothers consumption. month
fluoride varnish applicationDrug
Also called fluoride varnish (Duraphat 5% Na F ,Ultradent Products, Utah, USA)
The control group participated in a preventive program under the supervision of the Pediatric Dentistry Department. The program activities consisted of oral hygiene instructions, fluoride varnish application (Duraphat 5% Na F ,Ultradent Products, Utah, USA) and restorative treatment when needed.
| Study group | Role | What they receive |
|---|---|---|
| Experimental, control | Experimental | Mothers in the experimental group were instructed to chew 1 pellet of xylitol gum (Fennobon Oy, Yrittäjäntie, Finneland -gum, 3 times ) for a period of 3 months. control mothers did not receive any medications. All mothers received oral hygiene instructions and restorative treatment when needed. Offspring of both the experimental and control groups did not receive any medication and were followed for at 6,12, 18 and 24 month from initiation of mothers consumption. month Receives: Drug: xylitol |
| fluoride varnish application | Active comparator | The control group participated in a preventive program under the supervision of the Pediatric Dentistry Department. The program activities consisted of oral hygiene instructions, fluoride varnish application (Duraphat 5% Na F ,Ultradent Products, Utah, USA) and restorative treatment when needed. Receives: Drug: fluoride varnish application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assesment of mutans streptococci count in off-spring
Collection of saliva samples was carried out for microbiological screening after 6, 12, 18 and 24 months from the initiation xylitol consumption .Un stimulated saliva samples were collected from each child for salivary bacterial level screening. Saliva sampling was performed before conducting the clinical examination between 9-11 am. Children were not allowed to eat or drink for 2 hours before sampling. Saliva was collected with the pipette supplied by the dentocult (CRT) kit. (Ivoclar Vivadent, Lichtenstein). Saliva sample was not taken if the child has received antibiotics within 1 month prior the examination. Screening of stimulated saliva samples for mutans streptococcus (MS) level were carried out using the dentocult method (CRT). Findings of 105 CFU or more of MS indicates a high caries risk, whereas findings less than 105 CFU is considered low caries risk.
Measured: 24 month
Secondary outcomes (1)
Assesment of Caries level in off-spring
Clinical examination was carried out for dmft score for deciduous teeth after 6, 12, 18 and 24 months from the initiation maternal xylitol consumption. The diagnosis of dental caries was based on the WHO criteria 1987.
.
Measured: 24 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2014 (estimated)
- Study startFeb 2009
- Primary completionJul 2011
- Study completionSep 2011
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 Caries and Streptococcus Mutans CountStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Abdulaziz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Najlaa Alamoudi, King Abdulaziz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02036151
- Sponsor's protocol ID
- KAU
- Status last verified
- Jan 2014
- First submitted
- 31 Dec 2013
- Last updated
- 14 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Alamoudi NM, Hanno AG, Sabbagh HJ, Masoud MI, Almushayt AS, El Derwi DA. Impact of maternal xylitol consumption on mutans streptococci, plaque and caries levels in children. J Clin Pediatr Dent. 2012 Winter;37(2):163-6. doi: 10.17796/jcpd.37.2.261782tq73k4414x.
PubMed 23534323
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Maternal Xylitol Consumption on Mutans Sterptococci ,Plaque and Caries Levels in Children
- ClinicalTrials.gov ID
- NCT02036151
- Acronym / sponsor ID
- KAU
- Keywords
- Xylitol, prevention, Mutans streptococci, caries, plaque, children
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- King Abdulaziz UniversityUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Jul 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 14 Jan 2014 (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 study was designed to determine whether maternal xylitol consumption through regular chewing of xylitol gums can affect the salivary mutans streptococci (MS), dental caries, and dental plaque levels of their children.
Detailed description
Method: Study sample included 60 mother and child pairs with high salivary mutans streptococcus (MS) levels. Samples were randomly divided into experimental group (30 pairs) and control group (30 pairs). Mothers in the experimental group received xylitol chewing gum treatment three times/day for three months, whereas the controls received fluoride varnish. Both groups received oral hygiene instructions, dietary counseling and restorative treatment. All children were examined after 6, 12 and 18 months from the initiation of the study to assess caries, plaque and salivary mutans streptococcus (MS) levels.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental, control | Experimental | Drug: xylitolMothers in the experimental group were instructed to chew 1 pellet of xylitol gum (Fennobon Oy, Yrittäjäntie, Finneland -gum, 3 times ) for a period of 3 months. control mothers did not receive any medications. All mothers received oral hygiene instructions and restorative treatment when needed. Offspring of both the experimental and control groups did not receive any medication and were followed for at 6,12, 18 and 24 month from initiation of mothers consumption. month |
| fluoride varnish application | Active comparator | Drug: fluoride varnish applicationThe control group participated in a preventive program under the supervision of the Pediatric Dentistry Department. The program activities consisted of oral hygiene instructions, fluoride varnish application (Duraphat 5% Na F ,Ultradent Products, Utah, USA) and restorative treatment when needed. |
Who may qualify
- Ages
- 10 to 36 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- mothers with high salivary counts (≥ 105)
- mothers having children at least 10 months of age (10-36months) or having a minimal of 8 primary teeth.
Key exclusion criteria (1 listed)
- subjects with systemic disorders or on regular medications
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 |
|---|---|---|
| xylitolAlso: Fennobon Oy, Yrittäjäntie, Finneland - chewing, gum, tablet , 1.8g and containing 66% xylitol by weight,Mothers in the experimental group were instructed to chew 1 pellet of xylitol gum (Fennobon Oy, Yrittäjäntie, Finneland -gum, 3 times ) for a period of 3 months. control mothers did not receive any medications. All mothers received oral hygiene instructions and restorative treatment when needed. Offspring of both the experimental and control groups did not receive any medication and were followed for at 6,12, 18 and 24 month from initiation of mothers consumption. month | Drug | Experimental, control |
| fluoride varnish applicationAlso: fluoride varnish (Duraphat 5% Na F ,Ultradent Products, Utah, USA)The control group participated in a preventive program under the supervision of the Pediatric Dentistry Department. The program activities consisted of oral hygiene instructions, fluoride varnish application (Duraphat 5% Na F ,Ultradent Products, Utah, USA) and restorative treatment when needed. | Drug | fluoride varnish application |
Primary outcome
Assesment of mutans streptococci count in off-spring
Time frame: 24 month
Collection of saliva samples was carried out for microbiological screening after 6, 12, 18 and 24 months from the initiation xylitol consumption .Un stimulated saliva samples were collected from each child for salivary bacterial level screening. Saliva sampling was performed before conducting the clinical examination between 9-11 am. Children were not allowed to eat or drink for 2 hours before sampling. Saliva was collected with the pipette supplied by the dentocult (CRT) kit. (Ivoclar Vivadent, Lichtenstein). Saliva sample was not taken if the child has received antibiotics within 1 month prior the examination. Screening of stimulated saliva samples for mutans streptococcus (MS) level were carried out using the dentocult method (CRT). Findings of 105 CFU or more of MS indicates a high caries risk, whereas findings less than 105 CFU is considered low caries risk.
1 secondary outcome
Assesment of Caries level in off-spring
Time frame: 24 month
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 14 Jan 2014.
- Results publication: PubMed 23534323Alamoudi NM, Hanno AG, Sabbagh HJ, Masoud MI, Almushayt AS, El Derwi DA. Impact of maternal xylitol consumption on mutans streptococci, plaque and caries levels in children. J Clin Pediatr Dent. 2012 Winter;37(2):163-6. doi: 10.17796/jcpd.37.2.261782tq73k4414x.
Related trials for Dental Caries and Streptococcus Mutans Count
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing xylitol and fluoride varnish application in people with Dental Caries and Streptococcus Mutans Count, run by King Abdulaziz University at 1 site in Saudi Arabia.
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 2 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 14 Jan 2014. 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 Saudi Arabia. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Assesment of mutans streptococci count in off-spring (time frame: 24 month). 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 NCT02036151, 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 14 Jan 2014.