White Spot Lesion of ToothPhase 1/2NCT03004196
Comparison of Efficacy Of Probiotic Toothpaste and Chlorhexidine Mouthwash To Reduce S.Mutans
A Phase 1/2 study testing Probiotic Toothpaste and Dr. Reddy's Clohex in people with White Spot Lesion of Tooth and Long Term Adverse Effects, run by Peoples University, Bhanpur, Bhopal at 1 site in India.
Trial summary
Orthodontic appliance causes increase in plaque accumulation, especially around brackets, wires and attachments. Advances in orthodontics in recent time have led to improved quality of appliance and treatment procedures ultimately resulting in improvised standard of patient care. Read more about this study
- Who is it for?
- Ages 15 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- White Spot Lesion of Tooth, Long Term Adverse Effects, Caries, Dental
- What is being tested?
- Probiotic Toothpaste and Dr. Reddy's Clohex
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIndia
- Study dates
- Sep 2015to Oct 2015
- Phase
- Phase 1/2
- 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 15 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Orthodontic Treatment With The Straight Wire Appliance (MBT, 0.022-in Slot; 3M Unitek, Monro- Via, Calif), Permanent Dentition (Excluding Third Molars)
- Good General Health (No Significant Medical History Or Drug Use During The Last Month)
- No Anti-inflammatory Or Antibiotic Medications Taken In The Month Before The Study
- No Chewing Gum Or, Mouthwash Used In The Last Week And During The Study
- Habit Of Brushing Twice Daily With Fluoride Toothpaste
Who cannot join
- -Patient with poor periodontal condition Patient with known medical condition e.g. Subacute bacterial, endocarditis , diabetes, valvular disease ,anaemia etc
Trial locations and contacts
1 site in 1 country.
India1 site
Peoples College Of Dental Science & Research Center
Bhopal, Madhya Pradesh, 462016
About this study
Official title: Comparison of Efficacy Of Probiotic Toothpaste and Chlorhexidine Mouthwash To Reduce Streptococcus Mutans in Plaque Around Orthodontic Brackets
Orthodontic appliance causes increase in plaque accumulation, especially around brackets, wires and attachments. Advances in orthodontics in recent time have led to improved quality of appliance and treatment procedures ultimately resulting in improvised standard of patient care.
These bacteria metabolize different kind of carbohydrates accumulated around orthodontic appliances and create acidic environment in the oral cavity leading to enamel demineralization around the brackets and white spot lesions.
This study was carried out to evaluate and compare the efficacy of probiotic toothpaste and chlorhexidine mouthwash in patients undergoing orthodontic treatment with individuals who are not using them.
Read the detailed description
INTRODUCTION - When the basic oral hygiene is poor, orthodontic appliances create areas where plaque gets accumulated, especially around brackets, bands, wires, and other attachments; this facilitates the development of white spot lesions. Probiotics act by competitively inhibiting the pathogenic bacteria because they have greater adhesion to the tissues while Chlorhexidine is often used as an active ingredient in mouthwash designed to reduce dental plaque around orthodontic appliances. AIM \& OBJECTIVE - The objectives of the study is to evaluate and compare the effects of the topical application of probiotic toothpaste and chlorhexidine mouthwash on the Streptococcus Mutans levels in the plaque of orthodontic patients hence improving the oral micro-flora of oral cavity by competitive inhibition of Streptococcus Mutans in plaque present around brackets.
MATERIAL \& METHOD - The study consists of thirty randomly selected orthodontic patients undergoing fixed appliance treatment. The patients were divided into three groups - Control Group (Group 1), Probiotic Toothpaste Group (Group 2) \& Chlorhexidine Mouthwash Group (Group 3). Samples were collected at two times interval: before the study began (Phase 1) and after thirty days (Phase 2).
- Conditions
- White Spot Lesion of Tooth, Long Term Adverse Effects, Caries, Dental, Orthodontic Appliance Complication
- Being tested
- Probiotic Toothpaste, Dr. Reddy's Clohex, Control Group
- Keywords
- White Spot Lesion, Probiotics, Chlorhexidine, Streptococcus Mutans, Fixed Orthodontic Treatment
- Medical subject headings
- Long Term Adverse Effects, Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic ToothpasteDrug
Also called G.D Probiotic Toothpaste
G.D Probiotic Toothpaste bacteriocin Lactic Acid Bacteria
Dr. Reddy's ClohexDrug
Also called Chlorhexidine Mouthwash
0.20% Chlorhexidine Mouthwash
Control GroupOther
No Probiotic toothpaste \& Chlorhexidine Mouthwash
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | They were not given probiotic toothpaste or chlorhexidine mouthwash Receives: Other: Control Group |
| Probiotic Group | Experimental | Patients were asked to brush twice daily with given "G.D Probiotic Toothpaste" and were asked not to eat or drink anything for half-an-hour. Receives: Drug: Probiotic Toothpaste |
| Chlorhexidine Mouthwash Group | Experimental | Patients were asked to rinse daily with "Dr. Reddy's Clohex" chlorhexidine mouthwash of 10ml without dilution for three times a day after meals (Breakfast, Lunch Dinner) for 3-4 minutes and were asked not to eat or drink anything for half-an-hour. Receives: Drug: Dr. Reddy's Clohex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Control Group/Probiotic Toothpaste/Chlorhexidine Mouthwash
Probiotic Toothpaste \& Chlorhexidine Mouthwash Reduced S.mutans when compared to Control Group
Measured: 1 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2016 (estimated)
- Study startSep 2015
- Primary completionOct 2015
- Study completionOct 2015
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 White Spot Lesion of ToothStudies 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peoples University, Bhanpur, Bhopal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chandrika Dubey, Peoples University, Bhanpur, Bhopal
- Investigators
- Dr.Chandrika Dubey, MDS, Principal investigator, Peoples University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03004196
- Sponsor's protocol ID
- CD-01
- Status last verified
- Dec 2016
- First submitted
- 2 Dec 2016
- Last updated
- 28 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
Jose JE, Padmanabhan S, Chitharanjan AB. Systemic consumption of probiotic curd and use of probiotic toothpaste to reduce Streptococcus mutans in plaque around orthodontic brackets. Am J Orthod Dentofacial Orthop. 2013 Jul;144(1):67-72. doi: 10.1016/j.ajodo.2013.02.023.
PubMed 23810047
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficacy Of Probiotic Toothpaste and Chlorhexidine Mouthwash To Reduce Streptococcus Mutans in Plaque Around Orthodontic Brackets
- ClinicalTrials.gov ID
- NCT03004196
- Acronym / sponsor ID
- CD-01
- Conditions
- White Spot Lesion of Tooth, Long Term Adverse Effects, Caries, Dental, Orthodontic Appliance Complication
- Keywords
- White Spot Lesion, Probiotics, Chlorhexidine, Streptococcus Mutans, Fixed Orthodontic Treatment
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Peoples University, Bhanpur, BhopalUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 28 Dec 2016 (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.
Orthodontic appliance causes increase in plaque accumulation, especially around brackets, wires and attachments. Advances in orthodontics in recent time have led to improved quality of appliance and treatment procedures ultimately resulting in improvised standard of patient care.
These bacteria metabolize different kind of carbohydrates accumulated around orthodontic appliances and create acidic environment in the oral cavity leading to enamel demineralization around the brackets and white spot lesions.
This study was carried out to evaluate and compare the efficacy of probiotic toothpaste and chlorhexidine mouthwash in patients undergoing orthodontic treatment with individuals who are not using them.
Detailed description
INTRODUCTION - When the basic oral hygiene is poor, orthodontic appliances create areas where plaque gets accumulated, especially around brackets, bands, wires, and other attachments; this facilitates the development of white spot lesions. Probiotics act by competitively inhibiting the pathogenic bacteria because they have greater adhesion to the tissues while Chlorhexidine is often used as an active ingredient in mouthwash designed to reduce dental plaque around orthodontic appliances. AIM \& OBJECTIVE - The objectives of the study is to evaluate and compare the effects of the topical application of probiotic toothpaste and chlorhexidine mouthwash on the Streptococcus Mutans levels in the plaque of orthodontic patients hence improving the oral micro-flora of oral cavity by competitive inhibition of Streptococcus Mutans in plaque present around brackets.
MATERIAL \& METHOD - The study consists of thirty randomly selected orthodontic patients undergoing fixed appliance treatment. The patients were divided into three groups - Control Group (Group 1), Probiotic Toothpaste Group (Group 2) \& Chlorhexidine Mouthwash Group (Group 3). Samples were collected at two times interval: before the study began (Phase 1) and after thirty days (Phase 2).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Other: Control GroupThey were not given probiotic toothpaste or chlorhexidine mouthwash |
| Probiotic Group | Experimental | Drug: Probiotic ToothpastePatients were asked to brush twice daily with given "G.D Probiotic Toothpaste" and were asked not to eat or drink anything for half-an-hour. |
| Chlorhexidine Mouthwash Group | Experimental | Drug: Dr. Reddy's ClohexPatients were asked to rinse daily with "Dr. Reddy's Clohex" chlorhexidine mouthwash of 10ml without dilution for three times a day after meals (Breakfast, Lunch Dinner) for 3-4 minutes and were asked not to eat or drink anything for half-an-hour. |
Who may qualify
- Ages
- 15 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Orthodontic Treatment With The Straight Wire Appliance (MBT, 0.022-in Slot; 3M Unitek, Monro- Via, Calif), Permanent Dentition (Excluding Third Molars)
- Good General Health (No Significant Medical History Or Drug Use During The Last Month)
- No Anti-inflammatory Or Antibiotic Medications Taken In The Month Before The Study
- No Chewing Gum Or, Mouthwash Used In The Last Week And During The Study
- Habit Of Brushing Twice Daily With Fluoride Toothpaste
Key exclusion criteria (1 listed)
- -Patient with poor periodontal condition Patient with known medical condition e.g. Subacute bacterial, endocarditis , diabetes, valvular disease ,anaemia etc
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 |
|---|---|---|
| Probiotic ToothpasteAlso: G.D Probiotic ToothpasteG.D Probiotic Toothpaste bacteriocin Lactic Acid Bacteria | Drug | Probiotic Group |
| Dr. Reddy's ClohexAlso: Chlorhexidine Mouthwash0.20% Chlorhexidine Mouthwash | Drug | Chlorhexidine Mouthwash Group |
| Control GroupNo Probiotic toothpaste \& Chlorhexidine Mouthwash | Other | Control Group |
Primary outcome
Control Group/Probiotic Toothpaste/Chlorhexidine Mouthwash
Time frame: 1 Month
Probiotic Toothpaste \& Chlorhexidine Mouthwash Reduced S.mutans when compared to Control Group
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 28 Dec 2016.
- Background: PubMed 23810047Jose JE, Padmanabhan S, Chitharanjan AB. Systemic consumption of probiotic curd and use of probiotic toothpaste to reduce Streptococcus mutans in plaque around orthodontic brackets. Am J Orthod Dentofacial Orthop. 2013 Jul;144(1):67-72. doi: 10.1016/j.ajodo.2013.02.023.
- Individual participant dataSharing planned: Yes
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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.
Dr.Chandrika Dubey, MDS principal investigator
Peoples University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Probiotic Toothpaste and Dr. Reddy's Clohex in people with White Spot Lesion of Tooth and Long Term Adverse Effects, run by Peoples University, Bhanpur, Bhopal at 1 site in India.
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 5 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 28 Dec 2016. 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 India. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Control Group/Probiotic Toothpaste/Chlorhexidine Mouthwash (time frame: 1 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 NCT03004196, 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 28 Dec 2016.