Dental CariesNCT03061422
Effect of Xylitol-Containing Chewing Gum With/Without Bicarbonate Versus Paraffin Pellet on Salivary pH
A study testing Xylitol, xylitol with bicarbonate and paraffin in people with Dental Caries, run by Cairo University at 1 site in Egypt.
Trial summary
36 eligible participants will be randomly divided into three groups (n=12) according to the tested chewing gum (A), where (A1) represents participants exposed to xylitol chewing gum, (A2) represents participants exposed to bicarbonate and xylitol chewing gum and (A3) represents control group where participants are… Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- Xylitol, xylitol with bicarbonate and paraffin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Mar 2017to 30 Nov 2018
- 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients eligible for the trial must comply with all of the following at randomization.
- Age range from 20-50 years
- High caries risk patients defined according to American Dental Association (ADA)
- Acidic baseline saliva pH
- Systematically healthy
- Not taking any medication interfering with saliva secretion
- Subjects who signed informed consent
Who cannot join
- (1) Subjects who wore orthodontic appliances or removable prosthesis (2) Subjects suffering from any medical or systematic disease (3) Smokers (4) Pregnant females (5) Allergy to any of chewing gum ingredients
Trial locations and contacts
1 site in 1 country.
howaida f. Fouad, master contact
About this study
Official title: Effect of Xylitol-Containing Chewing Gum With/Without Bicarbonate Versus Paraffin Pellet on Salivary pH in High Caries Risk Patients (A Randomized Clinical Trial)
36 eligible participants will be randomly divided into three groups (n=12) according to the tested chewing gum (A), where (A1) represents participants exposed to xylitol chewing gum, (A2) represents participants exposed to bicarbonate and xylitol chewing gum and (A3) represents control group where participants are exposed to paraffin pellet chewing. The pH of saliva will be evaluated according to time in relation to the gum chewing (T) where (T0) represent the pH before chewing, (T1) represent 5 minutes after gum chewing at fixed time of the day (in the morning from 10 to 11 am).
Direct benefit of the research to the human volunteer:
Read more
It is important for high caries risk patients to decrease caries susceptibility as this will eventually decrease their dental treatments and subsequently the treatment cost.
Scientific value and social benefits:
This study will benefit the dentist as the main goal of a dentist is to prevent rather than cure. Also, it will decrease the restorative work carried out by dentist and save this time for educating more patients about caries prevention methods.
Expected risk to the human subjects:
Allergic reactions due to any of the components of the materials used which is rare to occur.
- Conditions
- Dental Caries
- Being tested
- Xylitol, xylitol with bicarbonate, paraffin
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XylitolOther
caries prevention chewing gum
xylitol with bicarbonateOther
caries prevention chewing gum
paraffinOther
chewing gum
| Study group | Role | What they receive |
|---|---|---|
| xylitol chewing gum | Experimental | intervention Receives: Other: Xylitol |
| xylitol with bicarbonate chewing gum | Experimental | intervention Receives: Other: xylitol with bicarbonate |
| Paraffin pellet | Active comparator | comparator Receives: Other: paraffin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Salivary pH change
will be done by digital pH meter
Measured: an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start3 Mar 2017 (estimated)
- Primary completion1 Oct 2017 (estimated)
- Study completion30 Nov 2018 (estimated)
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 CariesStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Howaida Fakhry Fouad, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03061422
- Sponsor's protocol ID
- CEBC-CU-2017-02-14
- Status last verified
- Feb 2017
- First submitted
- 19 Feb 2017
- Last updated
- 24 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ballal RK, Bhat SS, Ramdas SS, Ballal S. Effect of Chewing Bicarbonate-containing Sugar-free Gum on the Salivary pH: An in vivo Study. Int J Clin Pediatr Dent. 2016 Jan-Mar;9(1):35-8. doi: 10.5005/jp-journals-10005-1330. Epub 2016 Apr 22.
PubMed 27274153
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Xylitol-Containing Chewing Gum With/Without Bicarbonate Versus Paraffin Pellet on Salivary pH in High Caries Risk Patients (A Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT03061422
- Acronym / sponsor ID
- CEBC-CU-2017-02-14
- Conditions
- Dental Caries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 3 Mar 2017 (estimated)
- Primary completion
- 1 Oct 2017 (estimated)
- Study completion
- 30 Nov 2018 (estimated)
- First posted
- 23 Feb 2017 (actual)
- 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.
36 eligible participants will be randomly divided into three groups (n=12) according to the tested chewing gum (A), where (A1) represents participants exposed to xylitol chewing gum, (A2) represents participants exposed to bicarbonate and xylitol chewing gum and (A3) represents control group where participants are exposed to paraffin pellet chewing. The pH of saliva will be evaluated according to time in relation to the gum chewing (T) where (T0) represent the pH before chewing, (T1) represent 5 minutes after gum chewing at fixed time of the day (in the morning from 10 to 11 am).
Direct benefit of the research to the human volunteer:
It is important for high caries risk patients to decrease caries susceptibility as this will eventually decrease their dental treatments and subsequently the treatment cost.
Scientific value and social benefits:
This study will benefit the dentist as the main goal of a dentist is to prevent rather than cure. Also, it will decrease the restorative work carried out by dentist and save this time for educating more patients about caries prevention methods.
Expected risk to the human subjects:
Allergic reactions due to any of the components of the materials used which is rare to occur.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| xylitol chewing gum | Experimental | Other: Xylitolintervention |
| xylitol with bicarbonate chewing gum | Experimental | Other: xylitol with bicarbonateintervention |
| Paraffin pellet | Active comparator | Other: paraffincomparator |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Patients eligible for the trial must comply with all of the following at randomization.
Key exclusion criteria (1 listed)
- (1) Subjects who wore orthodontic appliances or removable prosthesis (2) Subjects suffering from any medical or systematic disease (3) Smokers (4) Pregnant females (5) Allergy to any of chewing gum ingredients
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 |
|---|---|---|
| Xylitolcaries prevention chewing gum | Other | xylitol chewing gum |
| xylitol with bicarbonatecaries prevention chewing gum | Other | xylitol with bicarbonate chewing gum |
| paraffinchewing gum | Other | Paraffin pellet |
Primary outcome
Salivary pH change
Time frame: an average of 1 year
will be done by digital pH meter
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2017.
- Background: PubMed 27274153Ballal RK, Bhat SS, Ramdas SS, Ballal S. Effect of Chewing Bicarbonate-containing Sugar-free Gum on the Salivary pH: An in vivo Study. Int J Clin Pediatr Dent. 2016 Jan-Mar;9(1):35-8. doi: 10.5005/jp-journals-10005-1330. Epub 2016 Apr 22.
- Individual participant dataSharing planned: Undecided
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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.
howaida f. Fouad, master contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Xylitol, xylitol with bicarbonate and paraffin in people with Dental Caries, run by Cairo University at 1 site in Egypt.
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 7 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: status not confirmed, as of the sponsor's last update on 24 Feb 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact howaida f. Fouad, master (howaidafakhry@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Salivary pH change (time frame: an average of 1 year). 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 NCT03061422, 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 24 Feb 2017.