Effect of Use of Calcium Hydroxide and Metformin Intracanal Medicament After NSRCT

NCT06766201 | Completed Phase 2 DMC

• 1 other identifier: AMBIKA TEKTA
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Goal of this randomized clinical trial is evaluate the effect of Calcium Hydroxide and Metformin Intracanal Medicament on periapical healing after NSRCT. Population includes systemically healthy patient with radiographic evidence of apical periodontitis PAI score more then 3 will be recruited . Outcome will be assessed using periapical index scoring system at 6 and 12 months follow up period.

Conditions

Apical Periodontitis

Keywords

AP, metformin, calcium hydroxide, medicament

Outcome Measures

Primary Outcomes (1)

• periapical healing using the Periapical index score

  clinical and radiographic healing clinical and radiographic success at 6 and12 months follow .

  6 and12 months follow .

Secondary Outcomes (1)

• Clinical success

  6 and12 months follow .

Study Arms (2)

calcium hydroxide group

NO INTERVENTION

Calcium hydroxide is mixed with propylene glycol

metformin group

EXPERIMENTAL

metformin mixed with propylene glycol

Drug: Metformin

Interventions

Metformin DRUG

Metformin mixed with propylene glycol

Also known as: MF

metformin group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Mature permanent mandibular molar with necrotic pulp (absence of response to cold and electric pulp tester) and apical periodontitis requiring primary root canal treatment with radiographic evidence of periapical radiolucency (periapical index score ≥ 3).
• Age - Above 18 years
• Non-contributory medical history (ASA 1)
• Periodontally healthy tooth (probing depth \<4mm)

You may not qualify if:

• Patients who do not provide authorization for participation in the study
• History of analgesic intake in the previous 1 week, or antibiotic intake in 1 month
• Mandibular molar with no opposing teeth.
• Patients whose tooth had been previously accessed or endodontically treated.
• Patient on systemic MF or medication that interfere periapical healing
• Presence of bleeding on opening of pulp chamber.
• Diabetic, immunocompromised and pregnant patient.
• Teeth with cracks, fracture, internal and external resorption.
• Any medications that alter bone metabolism such as, immunosuppressive drugs, corticosteroids, hormone replacement therapy ,selective serotonin reuptake inhibitors, intravenous bisphosphonates, and/or antiresorptive treatment.

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

Study Sites (1)

Ambika Tekta

Rohtak, Haryana, 124001, India

Location

MeSH Terms

Conditions

Periapical Periodontitis

Interventions

Metformin

Condition Hierarchy (Ancestors)

Periapical Diseases; Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Dr. Sanjay Tewari, MDS

  Post Graduate Institute Of Dental Sciences,Rohtak

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal

Study Record Dates

• First Submitted: June 4, 2024
• First Posted: January 9, 2025
• Study Start: August 1, 2023
• Primary Completion: September 1, 2024
• Study Completion: January 1, 2025
• Last Updated: May 28, 2025

Record last verified: 2025-05

Locations

IN (1)