Dental PlaquePhase 4NCT01578603
Effects of Two Sugar Substituted Chewing Gums on Caries and Gingivitis Variables
A Phase 4 study testing xylitol and casein phosphopeptide amorphous calcium phosphate complex in people with Dental Plaque and Saliva Altered, run by Universidad de Antioquia at 1 site in Colombia.
Trial summary
The purpose of this study is to determine the effect of three times a day mastication, during a follow-up period of 4 weeks, of two sugar-substituted chewing gums on various factors associated with dental caries and gingivitis. Read more about this study
- Who is it for?
- Ages 16 to 34 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Plaque, Saliva Altered, Gingivitis
- What is being tested?
- xylitol and casein phosphopeptide amorphous calcium phosphate complex
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteColombia
- Study dates
- Jan 2011to May 2012
- 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 16 to 34 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- systemically healthy
- dental student
Who cannot join
- less than 26 teeth in mouth
- use of orthodontic appliances
- use of antibiotics the last 3 months
Trial locations and contacts
1 site in 1 country.
Colombia1 site
Facultad de Odontología, Universidad de Antioquia
Medellín, Antioquia
About this study
Official title: Effects of Two Sugar Substituted Chewing Gums Plus Tooth Brushing on Different Caries and Gingivitis Related Variables: a Double Blind, Randomized Controlled Clinical Trial
The purpose of this study is to determine the effect of three times a day mastication, during a follow-up period of 4 weeks, of two sugar-substituted chewing gums on various factors associated with dental caries and gingivitis.
Read the detailed description
The purpose of this paper is to compare the effect of daily consumption of two sugar-free chewing gum, one with Recaldent and one with Xylitol, added to traditional hygiene (brushing, fluoridated toothpaste and dental floss), in clinical features such as the accumulation of plaque and gingival inflammation, microbiological characteristics of saliva as the counts of cariogenic microorganisms and facultative anaerobes, and some physicochemical properties of saliva such as pH and concentrations of calcium and inorganic phosphate.
To this there was a general call among dental students at the University of Antioquia and those who expressed their intention to participate voluntarily with informed consent, were examined clinically and randomly assigned to one of the study groups (Recaldent or Xylitol) or the control group.
After a month of baseline examination and the daily use of the same instruments of oral hygiene and chewing of 6 pellets of each chewing gum (in the case of study groups), all variables are re-examined.
- Conditions
- Dental Plaque, Saliva Altered, Gingivitis
- Being tested
- xylitol, casein phosphopeptide amorphous calcium phosphate complex
- Keywords
- prevention & control, Xylitol, casein phosphopeptide amorphous calcium phosphate complex, Streptococcus mutans, saliva, dental plaque, gingivitis
- Medical subject headings
- Dental Plaque, Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
xylitolDietary supplement
Also called sugar alcohol
6 g/day, for a month, by chewing 2g three times daily after meals.
casein phosphopeptide amorphous calcium phosphate complexDietary supplement
Also called CPP-ACP complex
two pieces of the commercial presentation three times daily after meals
| Study group | Role | What they receive |
|---|---|---|
| sugar substituted chewing gum A | Experimental | Not described Receives: Dietary Supplement: casein phosphopeptide amorphous calcium phosphate complex |
| Sugar substituted chewing gum B | Experimental | Not described Receives: Dietary Supplement: xylitol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Turesky index
dental plaque assessment
Measured: a month
Secondary outcomes (8)
Gingival index
gingival inflammation
Measured: a month
salivary pH
Measured: a month
Streptococcus mutans
number of Streptococcus mutans in saliva
Measured: a month
Ca levels
levels of calcium in saliva
Measured: a month
facultative microorganisms
number of facultative microorganisms in saliva
Measured: a month
Lactobacillus
levels of Lactobacillus spp. in saliva
Measured: a month
phosphate levels
inorganic phosphate leves in saliva
Measured: a month
BOP index
bleeding on probing
Measured: a month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2012 (estimated)
- Study startJan 2011
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Antioquia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, María Cecilia Martínez-Pabón, Universidad de Antioquia
- Investigators
- Maria C Martínez-Pabón, MsC Microb, Study director, Universidad de Antioquia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01578603
- Sponsor's protocol ID
- 15-2010
- Status last verified
- May 2012
- First submitted
- 9 Apr 2012
- Last updated
- 10 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Two Sugar Substituted Chewing Gums Plus Tooth Brushing on Different Caries and Gingivitis Related Variables: a Double Blind, Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT01578603
- Acronym / sponsor ID
- 15-2010
- Conditions
- Dental Plaque, Saliva Altered, Gingivitis
- Keywords
- prevention & control, Xylitol, casein phosphopeptide amorphous calcium phosphate complex, Streptococcus mutans, saliva, dental plaque, gingivitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Universidad de AntioquiaUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 17 Apr 2012 (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 determine the effect of three times a day mastication, during a follow-up period of 4 weeks, of two sugar-substituted chewing gums on various factors associated with dental caries and gingivitis.
Detailed description
The purpose of this paper is to compare the effect of daily consumption of two sugar-free chewing gum, one with Recaldent and one with Xylitol, added to traditional hygiene (brushing, fluoridated toothpaste and dental floss), in clinical features such as the accumulation of plaque and gingival inflammation, microbiological characteristics of saliva as the counts of cariogenic microorganisms and facultative anaerobes, and some physicochemical properties of saliva such as pH and concentrations of calcium and inorganic phosphate.
To this there was a general call among dental students at the University of Antioquia and those who expressed their intention to participate voluntarily with informed consent, were examined clinically and randomly assigned to one of the study groups (Recaldent or Xylitol) or the control group.
After a month of baseline examination and the daily use of the same instruments of oral hygiene and chewing of 6 pellets of each chewing gum (in the case of study groups), all variables are re-examined.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sugar substituted chewing gum A | Experimental | Dietary Supplement: casein phosphopeptide amorphous calcium phosphate complex |
| Sugar substituted chewing gum B | Experimental | Dietary Supplement: xylitol |
Who may qualify
- Ages
- 16 to 34 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- systemically healthy
- dental student
Key exclusion criteria (3 listed)
- less than 26 teeth in mouth
- use of orthodontic appliances
- use of antibiotics the last 3 months
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: sugar alcohol6 g/day, for a month, by chewing 2g three times daily after meals. | Dietary supplement | Sugar substituted chewing gum B |
| casein phosphopeptide amorphous calcium phosphate complexAlso: CPP-ACP complextwo pieces of the commercial presentation three times daily after meals | Dietary supplement | sugar substituted chewing gum A |
Primary outcome
Turesky index
Time frame: a month
dental plaque assessment
8 secondary outcomes
Gingival index
Time frame: a month
salivary pH
Time frame: a month
Streptococcus mutans
Time frame: a month
Ca levels
Time frame: a month
facultative microorganisms
Time frame: a month
Lactobacillus
Time frame: a month
phosphate levels
Time frame: a month
BOP index
Time frame: a 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 10 May 2012.
Related trials for Dental Plaque
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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.
Maria C Martínez-Pabón, MsC Microb study director
Universidad de Antioquia
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 casein phosphopeptide amorphous calcium phosphate complex in people with Dental Plaque and Saliva Altered, run by Universidad de Antioquia at 1 site in Colombia.
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 3 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 10 May 2012. 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 Colombia. 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?
Turesky index (time frame: a month). It is what the study was designed to measure, not a finding.
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 10 May 2012.