A Study Comparing Two Gels to Treat Gum Diseases

A prospective multicentric randomized active controlled open label study evaluating the efficacy and safety of Lignocaine gel with Chlorhexidine gluconate gel in the management of gingivitis and or Stage I and II periodontitis - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/06/088713

Enrollment

208

Registered

2025-06-12

Start date

Unknown

Completion date

Unknown

Last updated

2025-06-24

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

Conditions

Health Condition 1: K054- Periodontosis

Interventions

Intervention1: Lignocaine (2% w/w) +Metronidazole (1% w/w) +Chlorhexidine (1% w/w) gel: Duration is 21 days Control Intervention1: Chlorhexidine gluconate gel (1% w/w): Duration is 21 days

Eligibility

Inclusion criteria

Inclusion criteria: 1 Gingivitis and/or Stage I or Stage II periodontitis And Presence of mild to moderate discomfort which can manifest as pain 2 gingival tenderness on palpation or a general sense of unease in the affected area. 3 The pain may range from mild discomfort during routine oral functions such as chewing brushing or speaking to more persistent spontaneous pain at rest. Other mandates 1 Male or Female aged 18 60 years 2 Willingness to adhere to the study protocol and provide informed consent

Exclusion criteria

Exclusion criteria: 1 Known allergy to any component of the gels. 2 History of Smoking 3 Use of systemic antibiotics within the last 30 days. 4 Pregnant or lactating women. 5 Grade 3 periodontitis. 6 Aggressive periodontitis. 7 Acute Necrotizing Ulcerative Periodontitis (ANUP) 8 Acute Necrotizing Ulcerative Gingivitis (ANUG) 9 History of systemic diseases

Design outcomes

Primary

Measure	Time frame
Primary Outcome Improvement in Gingival Index Primary Outcome Improvement in Gingival Index Co-primary Outcome Reduction in Probing Pocket Depth Secondary Outcomes Reduction in Plaque Index Reduction in Bleeding on Probing Reduction in Pain Increased Treatment Satisfaction Monitoring of Serious Adverse Events Reduction in NSAID Use in Control Group Co-primary Outcome Reduction in Probing Pocket DepthTimepoint: Day 0 Baseline assessment Informed consent Medical history and oral hygiene habits Clinical exam: GI, PPD, PI, BOP, Pain Randomization to test or control group Day 10 First follow-up Reassessment: GI, PPD, PI, BOP, Pain Adverse event monitoring Day 21 Final follow-up Final assessment: GI, PPD, PI, BOP, Pain Treatment satisfaction questionnaire NSAID usage evaluation in control group Adverse event documentation	—

Measure

Time frame

Primary Outcome Improvement in Gingival Index Primary Outcome Improvement in Gingival Index Co-primary Outcome Reduction in Probing Pocket Depth Secondary Outcomes Reduction in Plaque Index Reduction in Bleeding on Probing Reduction in Pain Increased Treatment Satisfaction Monitoring of Serious Adverse Events Reduction in NSAID Use in Control Group Co-primary Outcome Reduction in Probing Pocket DepthTimepoint: Day 0 Baseline assessment Informed consent Medical history and oral hygiene habits Clinical exam: GI, PPD, PI, BOP, Pain Randomization to test or control group Day 10 First follow-up Reassessment: GI, PPD, PI, BOP, Pain Adverse event monitoring Day 21 Final follow-up Final assessment: GI, PPD, PI, BOP, Pain Treatment satisfaction questionnaire NSAID usage evaluation in control group Adverse event documentation

—

Secondary

Measure	Time frame
NilTimepoint: Nil	—

Countries

India

Contacts

Public ContactDr Pooja Kunjan

Indian Dental Association

drlakshmi@idrf.org.in919742504911

Outcome results

None listed

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