A study to test if the probiotic Lactobacillus paracasei GMNL-33 can improve gum health in people receiving regular treatment for gum disease

Evaluation of the efficacy of L. paracasei GMNL-33 as an effective adjunct in periodontal therapy - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/10/096331

Enrollment

144

Registered

2025-10-22

Start date

Unknown

Completion date

Unknown

Last updated

2025-11-17

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: L paracasei GMNL 33: probiotic supplements sporlac DG mouth dissolving tablets containing heat killed Lactobacillus paracaesi GMNL-33 oral tablet once after dinner Control Intervention

Eligibility

Inclusion criteria

Inclusion criteria: INCLUSION CRITERIA: 1. Systemically healthy patients of age 30 to 60 are to be recruited for the study Gingivitis patients with presence of bleeding on probing with no attachment loss 2.Stage 1 and 2 periodontitis patients presenting with PPD greater than 4 mm with CAL greater than 4mm in atleast 30 percentage of the teeth 3 periodontitis patients presenting with PPD greater than 5mm with CAL greater than 5mm in atleast 30 percent of the teeth

Exclusion criteria

Exclusion criteria: 1. Patients with any inflammatory systemic conditions such as diabetes mellitus, rheumatoid arthritis, etc. 2. Patients with immunodeficiency disorders. 3. Patients with local modifiers like food impaction, factitious habits and bruxism. 4. Patients who smoke. 5. Use of orthodontic and prosthetic appliances. 6.Patients who had taken systemic antibiotic, antiinflammatory, hormonal or other assisted drug therapy in the last 6 months or prior to the study.

Design outcomes

Primary

Measure	Time frame
PRIMARY OBJECTIVE: The primary outcomes of the trial were changes in CAL and PPD in periodontitis group ,percentage (%) of gingival sites with bleeding on probing BOPIn Gingivitis group Timepoint: 2 months and 6 months	—

Secondary

Measure	Time frame
SECONDARY OBJECTIVE: The secondary outcomes were to evaluate the microbial colonization of P gingivalis, T denticola and T forsythia and biochemical parameters the changes in the proinflammatory markers 1L1beta ,IL6,TNFalpha and antiinflammatory markers like 1L10. Additionally, halitosis will be evaluated as a clinical parameter. Patients to be assessed for quality of life using OHIP 14 questionaarie) at baseline, 30 days and 60 days for both the groups to determine the overall impact of treatment on their well being. Timepoint: 2months and 6 months	—

Measure

Time frame

SECONDARY OBJECTIVE: The secondary outcomes were to evaluate the microbial colonization of P gingivalis, T denticola and T forsythia and biochemical parameters the changes in the proinflammatory markers 1L1beta ,IL6,TNFalpha and antiinflammatory markers like 1L10. Additionally, halitosis will be evaluated as a clinical parameter. Patients to be assessed for quality of life using OHIP 14 questionaarie) at baseline, 30 days and 60 days for both the groups to determine the overall impact of treatment on their well being. Timepoint: 2months and 6 months

—

Countries

India

Contacts

Public ContactDr PSG PRAKASH

SRM DENTAL COLLEGE,Ramapuram campus

akashpsg@gmail.com9840870990

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026