A Study Comparing Two Gels to Treat Gum Diseases

Phase 3

Not yet recruiting

• Conditions: Periodontosis,

• Registration Number: CTRI/2025/06/088713
• Lead Sponsor: JB Pharmaceuticals

Brief Summary

This multicentric, randomised, open label clinical trial evaluates the efficacy and safety of a combination gel containing lignocaine metronidazole and chlorhexidine compared to standard to standard chlorhexidine gel in managing gingivitis and stage I/II periodontitis. A total of 208 adult participants are randomized onto two groups. Assessments are conducted at baseline, Day 10, and Day 21. The study focuses on the improvements in gingival health, clinical parameters, symptom relief, patient satisfaction and safety. If effective the combination gel could offer a simplified and more comfortable treatment alternative for early periodontal conditions

Detailed Description

Not available

Study Timeline

• Study Start: 2025-07-17
• Last Update Posted: 2025-11-06

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 208

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

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Outcome	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
Improvement in Gingival Index	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
Co-primary Outcome	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
Reduction in Probing Pocket Depth	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 Outcomes	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
Reduction in Plaque Index	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
Increased Treatment Satisfaction	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
Reduction in Bleeding on Probing	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
Reduction in NSAID Use in Control Group	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
Reduction in Pain	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
Monitoring of Serious Adverse Events	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 Outcome Measures

Name	Time	Method
Primary Outcome	Improvement in Gingival Index

Trial Locations

Locations (3)

K D Dental College & 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 & Hospital

🇮🇳Mathura, UTTAR PRADESH, India

Dr Aditya Sinha

Principal investigator

adityasinhamds@gmail.com