After professional cleaning for gum disease, does probiotic (good bacteria) toothpaste or regular fluoride toothpaste work better in reducing harmful bacteria.

Comparative effectiveness of probiotic toothpaste and fluoridated toothpaste as adjuncts to scaling and root planing on red complex bacteria in stage II periodontitis: A randomized controlled superiority trial in a tertiary care setting

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/04/108533

Enrollment

102

Registered

2026-04-16

Start date

Unknown

Completion date

Unknown

Last updated

2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K053- Chronic periodontitis

Interventions

Intervention1: Probiotic toothpaste containing Bacillus coagulans (200 million CFU/gm): Participants allocated to the intervention group will receive a commercially available probiotic toothpaste cont

Eligibility

Inclusion criteria

Inclusion criteria: Diagnosed with Stage II periodontitis based on 2017 World Workshop classification criteria Presence of at least 20 natural teeth excluding third molars and teeth indicated for extraction Moderate plaque levels at baseline Willing to undergo scaling and root planing Able and willing to provide written informed consent.

Exclusion criteria

Exclusion criteria: Presence of systemic diseases affecting periodontal status (e.g., diabetes mellitus, immunosuppression, chronic kidney disease). Pregnant or lactating women. Current smokers or former smokers within the last 5 years. Use of antibiotics, antimicrobials, long-term anti-inflammatory drugs, or immunosuppressants within the past 3 months. History of allergy or hypersensitivity to any component of the study toothpastes. Periodontal treatment within the last 6 months. Regular consumption of probiotic supplements or probiotic-containing products within the last 3 months.

Design outcomes

Primary

Measure	Time frame
Proportion of participants achieving a negative result for red complex bacteria at 1 month following intervention, as assessed by the AMA DENT Point-of-Care (POC) test. The outcome will be recorded as a binary variable (Positive/Negative) and compared between the probiotic toothpaste and fluoridated toothpaste groups.Timepoint: baseline to 1 month	—

Secondary

Measure	Time frame
Change in Gingival Index (GI) from baseline to 1 month. Change in Plaque Index (PI) from baseline to 1 month. Change in Bleeding on Probing percentage (BOP%) from baseline to 1 month. Change in Probing Pocket Depth (PPD) from baseline to 1 month. Patient-reported acceptability of the assigned toothpaste measured using a Likert-scale questionnaire at 1 month. Cost-effectiveness outcomes (incremental cost per unit reduction in microbiological and clinical parameters) calculated at the end of the 1-month follow-up period.Timepoint: Baseline to 1 month	—

Measure

Time frame

Change in Gingival Index (GI) from baseline to 1 month. Change in Plaque Index (PI) from baseline to 1 month. Change in Bleeding on Probing percentage (BOP%) from baseline to 1 month. Change in Probing Pocket Depth (PPD) from baseline to 1 month. Patient-reported acceptability of the assigned toothpaste measured using a Likert-scale questionnaire at 1 month. Cost-effectiveness outcomes (incremental cost per unit reduction in microbiological and clinical parameters) calculated at the end of the 1-month follow-up period.Timepoint: Baseline to 1 month

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Countries

India

Contacts

Public ContactDr Anoop S

Government Dental College, Alappuzha

drsreeraj@gmail.com9400316183

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026