Effect of Probiotic Toothpaste and Regular Toothpaste on Plaque Levels of Orthodontic Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-04

Study Completion Date

2024-07-15

Brief Summary

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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.

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Detailed Description

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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

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Plaque

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

For reexamination at T1, the investigators were blinded to the intervention.

Study Groups

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Colgate Maximum Cavity Protection (Control)

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Probiotic Toothpaste Group

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.

Group Type EXPERIMENTAL

Probiotic Toothpaste

Intervention Type OTHER

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.

Interventions

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Probiotic Toothpaste

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.

Intervention Type OTHER

Other Intervention Names

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PerioBiotic Toothpaste - Dental Probiotic Tooth Paste

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes