Comparing Metformin, Double Antibiotic Paste, and Calcium Hydroxide for Tooth Pain

Evaluation of the Efficacy of Metformin, Metformin Combined with Double Antibiotic Paste, and Calcium Hydroxide Paste as Intracanal Medicaments for Reducing Post-Operative Pain in Patients with Symptomatic Irreversible Pulpitis: A Randomized Controlled Study - NIL

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/05/086949

Enrollment

Registered

2025-05-14

Start date

Unknown

Completion date

Unknown

Last updated

2025-05-26

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

Conditions

Health Condition 1: K040- Pulpitis

Interventions

Intervention1: Root Canal Treatment with Metformin as intracanal medicament : Group I- Will receive Metformin as Intracanal medicament and the pain will be evaluated at 12, 24, 48, and 72 hours using

Eligibility

Inclusion criteria

Inclusion criteria: Patients must be above 18 years,Patients should have no significant medical history, Patients should have no history of allergy to medications used in root canal treatment Patients diagnosed with Symptomatic Irreversible Pulpitis. Patients with a history of severe pain with visual and radiographically presence of a carious lesion. Only patients with single-rooted teeth will be included

Exclusion criteria

Exclusion criteria: Teeth with root resorption or intracanal calcifications, Patients requiring treatment for multi-rooted teeth and those with pulp necrosis, Those who did not fulfil the inclusion criteria Non-compliance with treatment visits and non-willingness to participate in the study.

Design outcomes

Primary

Measure	Time frame
Reduction in post-operative pain intensity following root canal treatment, measured using a validated pain assessment tool Visual Analog Scale [VAS] at specific time intervals 12, 24, 48, and 72 hours post-operatively. This outcome directly assesses the comparative analgesic effectiveness of the three intracanal medicaments in managing post-treatment pain in patients diagnosed with symptomatic irreversible pulpitis.Timepoint: Reduction in post-operative pain intensity following root canal treatment, measured using a validated pain assessment tool Visual Analog Scale [VAS] at specific time intervals 12, 24, 48, and 72 hours post-operatively. This outcome directly assesses the comparative analgesic effectiveness of the three intracanal medicaments in managing post-treatment pain in patients diagnosed with symptomatic irreversible pulpitis.	—

Measure

Time frame

Reduction in post-operative pain intensity following root canal treatment, measured using a validated pain assessment tool Visual Analog Scale [VAS] at specific time intervals 12, 24, 48, and 72 hours post-operatively. This outcome directly assesses the comparative analgesic effectiveness of the three intracanal medicaments in managing post-treatment pain in patients diagnosed with symptomatic irreversible pulpitis.Timepoint: Reduction in post-operative pain intensity following root canal treatment, measured using a validated pain assessment tool Visual Analog Scale [VAS] at specific time intervals 12, 24, 48, and 72 hours post-operatively. This outcome directly assesses the comparative analgesic effectiveness of the three intracanal medicaments in managing post-treatment pain in patients diagnosed with symptomatic irreversible pulpitis.

—

Secondary

Measure	Time frame
The evaluation of periapical healing based on clinical and radiographic findings at specified follow-up intervals 1 week, 1 month, and 3 months, the incidence of inter-appointment flare-ups or adverse events, the number of analgesic tablets consumed post-operatively, and the overall patient-reported treatment satisfaction.Timepoint: 1 week, 1 month, and 3 months	—

Countries

India

Contacts

Public ContactDr P Rajani

Kamineni Institute Of Dental Sciences

sayini.endo@gmail.com919177607313

Outcome results

None listed

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