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

NCT06473792 | Completed DMC

• 1 other identifier: 2023-7853-26493
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Plaque

Keywords

Plaque; Gingivitis; Probiotics

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

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.

Other: Probiotic Toothpaste

Interventions

Probiotic Toothpaste 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.

Also known as: PerioBiotic Toothpaste - Dental Probiotic Tooth Paste

Probiotic Toothpaste Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kanza Tahir: lead

Study Sites (1)

Aga Khan University

Karachi, Sindh, 24700, Pakistan

Location

Related Publications (1)

• 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.

  PMID: 39476739 DERIVED

MeSH Terms

Conditions

Plaque, Amyloid; Gingivitis

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Mubassar Fida, FCPS, MCPS

  Aga Khan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: For reexamination at T1, the investigators were blinded to the intervention.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr. Kanza Tahir

Study Record Dates

• First Submitted: June 19, 2024
• First Posted: June 25, 2024
• Study Start: June 4, 2024
• Primary Completion: July 6, 2024
• Study Completion: July 15, 2024
• Last Updated: August 2, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)