Clinical trial NCT06473792: Effect of Probiotic Toothpaste and Regular Toothpaste on Plaque Levels of Orthodontic Patients
Official title: Effect of Probiotic Toothpaste and Regular Toothpaste on Plaque Levels of Orthodontic - A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Plaque
Keywords: Plaque
Gingivitis
Probiotics
Lead sponsor: Aga Khan University
Sponsor class: OTHER
First posted: 2024-06-25
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Plaque Index Simplified
timeFrame: Before and three weeks after bonding
measure: Gingival Index
timeFrame: Before and three weeks after bonding
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Aga Khan University
state: Sindh
Study officials:
affiliation: Aga Khan University
name: Mubassar Fida, FCPS, MCPS
role: PRINCIPAL_INVESTIGATOR
References: