PlaqueNCT06473792
Effect of Probiotic Toothpaste and Regular Toothpaste on Plaque Levels of Orthodontic Patients
A study testing Probiotic Toothpaste in people with Plaque, run by Kanza Tahir at 1 site in Pakistan.
Trial summary
This study is set to determine the improvement in plaque levels utilizing Plaque Index Simplified scores in orthodontic patients using probiotic toothpaste and regular toothpaste. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Plaque
- What is being tested?
- Probiotic Toothpaste
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 sitePakistan
- Study dates
- 4 Jun 2024to 15 Jul 2024
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients who will be initiating their orthodontic treatment by bonding of metal or ceramic brackets
- Patients age between 18 - 50 years
- Patients without any mental and physical disability or craniofacial disorders
- Patients without enamel or dentin dysplasia
- Patients not taking medications affecting plaque accumulation such as antibiotics or antibacterial mouth rinses
- Patients without periodontal disease or dental caries at the study onset
- Patients willing to follow-up after 3 weeks
Who cannot join
- Patients with neurological mental deficits or otherwise medically compromised
- Patients with past history of dental trauma or craniofacial syndromes
- Patients who are smokers
- Those patients who are already continuing their orthodontic treatment
- Patients with poor oral hygiene
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Probiotic Toothpaste and Regular Toothpaste on Plaque Levels of Orthodontic - A Randomized Controlled Trial
This study is set to determine the improvement in plaque levels utilizing Plaque Index Simplified scores in orthodontic patients using probiotic toothpaste and regular toothpaste.
It will further analyze the mean difference in oral hygiene scores between metal and ceramic brackets in regular toothpaste and probiotic toothpaste groups.
Read the detailed description
Probiotic toothpaste is formulated to introduce beneficial bacteria into the oral cavity, promoting a balanced microbiome and inhibiting the growth of pathogenic bacteria. Previous research suggests that probiotics can reduce plaque formation, gingival inflammation, and pathogenic bacterial load. By potentially improving the oral microbiome, probiotic toothpaste could offer a superior alternative to standard toothpaste for maintaining oral hygiene in orthodontic patients. Metal and ceramic brackets differ not only in aesthetics but also in their interaction with the oral environment. Ceramic brackets are more brittle and can be more prone to plaque accumulation due to their rougher surface compared to metal brackets. This study will determine the improvement in plaque levels utilizing Plaque Index Simplified scores in orthodontic patients using probiotic toothpaste and regular toothpaste.
It will further determine the mean difference in oral hygiene scores between metal and ceramic brackets in regular toothpaste and probiotic toothpaste groups.
Plaque will be assessed using plaque disclosing tablets before the bonding (T1) and 3 weeks after the bonding (T2). The data will be collected on Plaque Index Simplified chart. Eligible participants will be randomly allocated to one of the two groups.
Group A (Control): Participants will be advised to use regular toothpaste twice a day for 3 weeks after the bonding. A standard toothpaste and brushing technique will be conveyed to all the participants.
Group B (Intervention): Participants will be advised to use a Probiotic toothpaste twice a day for 3 weeks after the bonding. A probiotic toothpaste and brushing technique will be conveyed to all the participants.
The total sample size for each group would be 26. Since this study has 2 groups, a total number of 52 (N) will be required. Group 1: Regular toothpaste and Group 2: Probiotic toothpaste.
- Conditions
- Plaque
- Being tested
- Probiotic Toothpaste
- Keywords
- Plaque, Gingivitis, Probiotics
- Medical subject headings
- Plaque, Amyloid, Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic ToothpasteOther
Also called PerioBiotic Toothpaste - Dental Probiotic Tooth Paste
Composition: Main - Water, calcium carbonate, calcium glycerophosphate, glycerin, xylitol, sodium bicarbonate, sweet fennel oil (Foeniculum vulgare), carrageenan, maltodextrin, Dental-Lac (Lactobacillus paracasei), potassium sorbate, yucca (Y. filamentosa) powder, stevia leaf extract (Eupatorium rebaudiana bertoni), zinc chloride.
Usage: This is mint flavored toothpaste containing Lactobacillus paracasei which has demonstrated the ability to help address harmful strains of oral flora, and promotes the maintenance of a healthy teeth and gums. The participant will be instructed to brush with it twice daily.
| Study group | Role | What they receive |
|---|---|---|
| Colgate Maximum Cavity Protection (Control) | No intervention | Participants will be advised to use regular toothpaste twice a day for 3 weeks after the bonding. A regular toothpaste and a standard brushing technique will be conveyed to all the participants. |
| Probiotic Toothpaste Group | Experimental | Participants will be advised to use a Probiotic toothpaste twice a day for 3 weeks after the bonding. A probiotic toothpaste and a standard brushing technique will be conveyed to all the participants. Receives: Other: Probiotic Toothpaste |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plaque Index Simplified
Number of sites with plaque/ Number of sites evaluated x 100
Measured: Before and three weeks after bonding
Gingival Index
Gingival Index measures gingival condition of the marginal and interproximal tissues (mesial, lingual, distal, facial) separately on the basis of 0 to 3 with 0=Normal gingiva; 1= Mild inflammation - slight change in color and slight edema but no bleeding on probing; 2= Moderate inflammation - redness, edema and glazing, bleeding on probing; 3= Severe inflammation - marked redness and edema, ulceration with tendency to spontaneous bleeding.
Measured: Before and three weeks after bonding
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2024
- Study start4 Jun 2024
- Primary completion6 Jul 2024
- Study completion15 Jul 2024
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 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kanza Tahir
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kanza Tahir, Aga Khan University
- Investigators
- Mubassar Fida, FCPS, MCPS, Principal investigator, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06473792
- Sponsor's protocol ID
- 2023-7853-26493
- Status last verified
- Aug 2024
- First submitted
- 19 Jun 2024
- Last updated
- 2 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tahir K, Barakaat AA, Shoukat Ali U, Fida M, Sukhia RH. Effect of probiotic toothpaste and regular toothpaste on gingival health and plaque levels of adult orthodontic patients - An open label randomized controlled trial. Int Orthod. 2025 Mar;23(1):100938. doi: 10.1016/j.ortho.2024.100938. Epub 2024 Oct 30.
PubMed 39476739
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Probiotic Toothpaste and Regular Toothpaste on Plaque Levels of Orthodontic - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06473792
- Acronym / sponsor ID
- 2023-7853-26493
- Conditions
- Plaque
- Keywords
- Plaque, Gingivitis, Probiotics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Kanza TahirUniversity, hospital or other
- Study start
- 4 Jun 2024 (actual)
- Primary completion
- 6 Jul 2024 (actual)
- Study completion
- 15 Jul 2024 (actual)
- First posted
- 25 Jun 2024 (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.
This study is set to determine the improvement in plaque levels utilizing Plaque Index Simplified scores in orthodontic patients using probiotic toothpaste and regular toothpaste.
It will further analyze the mean difference in oral hygiene scores between metal and ceramic brackets in regular toothpaste and probiotic toothpaste groups.
Detailed description
Probiotic toothpaste is formulated to introduce beneficial bacteria into the oral cavity, promoting a balanced microbiome and inhibiting the growth of pathogenic bacteria. Previous research suggests that probiotics can reduce plaque formation, gingival inflammation, and pathogenic bacterial load. By potentially improving the oral microbiome, probiotic toothpaste could offer a superior alternative to standard toothpaste for maintaining oral hygiene in orthodontic patients. Metal and ceramic brackets differ not only in aesthetics but also in their interaction with the oral environment. Ceramic brackets are more brittle and can be more prone to plaque accumulation due to their rougher surface compared to metal brackets. This study will determine the improvement in plaque levels utilizing Plaque Index Simplified scores in orthodontic patients using probiotic toothpaste and regular toothpaste.
It will further determine the mean difference in oral hygiene scores between metal and ceramic brackets in regular toothpaste and probiotic toothpaste groups.
Plaque will be assessed using plaque disclosing tablets before the bonding (T1) and 3 weeks after the bonding (T2). The data will be collected on Plaque Index Simplified chart. Eligible participants will be randomly allocated to one of the two groups.
Group A (Control): Participants will be advised to use regular toothpaste twice a day for 3 weeks after the bonding. A standard toothpaste and brushing technique will be conveyed to all the participants.
Group B (Intervention): Participants will be advised to use a Probiotic toothpaste twice a day for 3 weeks after the bonding. A probiotic toothpaste and brushing technique will be conveyed to all the participants.
The total sample size for each group would be 26. Since this study has 2 groups, a total number of 52 (N) will be required. Group 1: Regular toothpaste and Group 2: Probiotic toothpaste.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Colgate Maximum Cavity Protection (Control) | No intervention | –Participants will be advised to use regular toothpaste twice a day for 3 weeks after the bonding. A regular toothpaste and a standard brushing technique will be conveyed to all the participants. |
| Probiotic Toothpaste Group | Experimental | Other: Probiotic ToothpasteParticipants will be advised to use a Probiotic toothpaste twice a day for 3 weeks after the bonding. A probiotic toothpaste and a standard brushing technique will be conveyed to all the participants. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Patients who will be initiating their orthodontic treatment by bonding of metal or ceramic brackets
- Patients age between 18 - 50 years
- Patients without any mental and physical disability or craniofacial disorders
- Patients without enamel or dentin dysplasia
- Patients not taking medications affecting plaque accumulation such as antibiotics or antibacterial mouth rinses
Key exclusion criteria (5 listed)
- Patients with neurological mental deficits or otherwise medically compromised
- Patients with past history of dental trauma or craniofacial syndromes
- Patients who are smokers
- Those patients who are already continuing their orthodontic treatment
- Patients with poor oral hygiene
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: PerioBiotic Toothpaste - Dental Probiotic Tooth PasteComposition: Main - Water, calcium carbonate, calcium glycerophosphate, glycerin, xylitol, sodium bicarbonate, sweet fennel oil (Foeniculum vulgare), carrageenan, maltodextrin, Dental-Lac (Lactobacillus paracasei), potassium sorbate, yucca (Y. filamentosa) powder, stevia leaf extract (Eupatorium rebaudiana bertoni), zinc chloride. Usage: This is mint flavored toothpaste containing Lactobacillus paracasei which has demonstrated the ability to help address harmful strains of oral flora, and promotes the maintenance of a healthy teeth and gums. The participant will be instructed to brush with it twice daily. | Other | Probiotic Toothpaste Group |
Primary outcome
Plaque Index Simplified
Time frame: Before and three weeks after bonding
Number of sites with plaque/ Number of sites evaluated x 100
Gingival Index
Time frame: Before and three weeks after bonding
Gingival Index measures gingival condition of the marginal and interproximal tissues (mesial, lingual, distal, facial) separately on the basis of 0 to 3 with 0=Normal gingiva; 1= Mild inflammation - slight change in color and slight edema but no bleeding on probing; 2= Moderate inflammation - redness, edema and glazing, bleeding on probing; 3= Severe inflammation - marked redness and edema, ulceration with tendency to spontaneous bleeding.
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 2 Aug 2024.
- Derived from this study: PubMed 39476739Tahir K, Barakaat AA, Shoukat Ali U, Fida M, Sukhia RH. Effect of probiotic toothpaste and regular toothpaste on gingival health and plaque levels of adult orthodontic patients - An open label randomized controlled trial. Int Orthod. 2025 Mar;23(1):100938. doi: 10.1016/j.ortho.2024.100938. Epub 2024 Oct 30.
- Individual participant dataSharing planned: No
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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.
Mubassar Fida, FCPS, MCPS principal investigator
Aga Khan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic Toothpaste in people with Plaque, run by Kanza Tahir at 1 site in Pakistan.
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 5 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 2 Aug 2024. 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 Pakistan. 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?
Plaque Index Simplified (time frame: Before and three weeks after bonding). The study lists 2 primary outcomes in all. 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 NCT06473792, 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 2 Aug 2024.