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

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.

Study Overview

• Status: Completed
• Conditions: Plaque
• Intervention / Treatment: Other: Probiotic Toothpaste

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 Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 24700
      • Aga Khan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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.
Experimental: 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.	Other: 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.; Other Names: PerioBiotic Toothpaste - Dental Probiotic Tooth Paste

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plaque Index Simplified	Number of sites with plaque/ Number of sites evaluated x 100	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.	Before and three weeks after bonding

Collaborators and Investigators

• Sponsor: Kanza Tahir
• Investigators: Principal Investigator: Mubassar Fida, FCPS, MCPS, Aga Khan University

Study record dates

Study Major Dates

• Study Start (Actual): June 4, 2024
• Primary Completion (Actual): July 6, 2024
• Study Completion (Actual): July 15, 2024

Study Registration Dates

• First Submitted: June 19, 2024
• First Submitted That Met QC Criteria: June 19, 2024
• First Posted (Actual): June 25, 2024

Study Record Updates

• Last Update Posted (Actual): August 2, 2024
• Last Update Submitted That Met QC Criteria: August 1, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Probiotics; Plaque; Gingivitis
• Other Study ID Numbers: 2023-7853-26493

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Study Data/Documents

1. Study Protocol
2. Informed Consent Form

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No