A Study on the Impact of a Nutraceutical Supplement on Oral Health and Microbiota in Children

Phase 3

Not yet recruiting

• Conditions: Plaque and Calculus in oral cavity

• Registration Number: CTRI/2025/06/089391
• Lead Sponsor: Lasarkaali Life Sciences Pvt Ltd

Brief Summary

This is a Pilot, open-label, multi-center, interventional clinical trial designed to evaluate the effectiveness of a nutraceutical formulation in improving oral microbiota balance and overall oral health in children aged 5 to 14 years. A total of 225 participants will be enrolled across three clinical sites. Subjects will receive a fixed dose of two functional probiotic-based candies per day for 42 days. The primary endpoint is the reduction in *Streptococcus mutans* and *Lactobacillus acidophilus* levels, assessed through agar culture methodology. Secondary endpoints include improvements in gingival health, reduction in halitosis, and evaluation of product safety and tolerability. The study aims to generate preliminary efficacy and safety data for this formulation as a supportive oral health supplement for pediatric use.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2025-06-19
• Study Start: 2025-07-14

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 225

Inclusion Criteria

• Healthy male and female subjects aged 5–14 years.
• No history of severe periodontal disease, recurrent oral infections, or advanced dental caries requiring medical intervention.
• No use of antibiotics, antifungal agents, or strong antiseptic mouthwashes within 30 days prior to study enrollment.
• Willing to maintain regular oral hygiene practices during the study.

Exclusion Criteria

• History of severe oral disease requiring medical intervention.
• Use of antibiotics, antifungal agents, or strong antiseptic mouthwashes within 30 days before screening.
• Pregnant or lactating women.
• Known allergy to any ingredient in the Nutraceutical Formulation.
• Diagnosed gastrointestinal disorders that may interfere with probiotic absorption.
• Individuals currently enrolled in another clinical trial.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction in Streptococcus mutans and Lactobacillus acidophilus levels from baseline to Week 6.	At Week 6 Last microbiota sampling will be done i.e at 3rd follow up

Secondary Outcome Measures

Name	Time	Method
To evaluate the reduction in halitosis over 6 weeks using a questionnaire. (based on the perception of the subject).
To measure improvements in gingival health as assessed by Gingival Index scores.	At Week 6 gingival scores will be taken again i.e at 3rd follow up
To analyze microbial balance shifts that reduce harmful bacterial strains like Streptococcus mutans and Lactobacillus acidophilus	At Week 6 Last microbiota sampling will be done i.e at 3rd follow up

Trial Locations

Locations (3)

K.D. Dental College and Hospital; 🇮🇳 Mathura, UTTAR PRADESH, India

Sibar Institute of Dental Sciences; 🇮🇳 Guntur, ANDHRA PRADESH, India

Sinhgad dental college and hospital; 🇮🇳 Pune, MAHARASHTRA, India

K.D. Dental College and Hospital

🇮🇳Mathura, UTTAR PRADESH, India

DrSushma Gojanur

Principal investigator

9837230109

drsushmagojanur@yahoo.com