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

Last updated: May 5, 2025
Sponsor: Postgraduate Institute of Dental Sciences Rohtak
Overall Status: Completed

Phase

2

Condition

Periodontitis

Treatment

Metformin

Clinical Study ID

NCT06766201
AMBIKA TEKTA
  • Ages 18-55
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Mature permanent mandibular molar having apical periodontitis requiring primary rootcanal treatment with radiographic evidence of periapical radiolucency ( periapicalindex score ≥ 3.

  2. presence of sinus tract

  3. Non-contributory medical history

  4. No history of analgesic intake in the previous 1 week, or antibiotic intake in 1month.

  5. No prior endodontic treatment on the involved tooth

  6. Periodontally healthy (probing depth <4mm)

Exclusion

Exclusion Criteria:

  1. Patients who do not provide authorization for participation in the study

  2. Medically compromised patient ASA II, III, IV, V

  3. Mandibular molar with no opposing teeth.

  4. Patients whose tooth had been previously accessed or endodontically treated.

  5. Patient on systemic MF or medication that interfere periapical healing -

Study Design

Total Participants: 120
Treatment Group(s): 1
Primary Treatment: Metformin
Phase: 2
Study Start date:
August 01, 2023
Estimated Completion Date:
January 01, 2025

Study Description

AIM: To compare the efficacy of calcium hydroxide and metformin intracanal medicaments in healing of apical periodontitis in mature permanent mandibular molars. Objectives Primary objective: To determine the effect of calcium hydroxide and metformin intracanal medicaments on healing of apical periodontitis in mature permanent mandibular molars using periapical index (PAI) score. Secondary objective: assess postoperative pain after chemo mechanical preparation and intracanal dressing of calcium hydroxide or metformin using visual analogue scale (VAS)

Clinical procedure Mature permanent mandibular teeth with diagnosis of apical periodontitis (as confirmed clinically & by periapical radiograph) will be chosen for the study. 17 Patients will be randomly allocated to either of the two groups- Group A (calcium hydroxide), Group B (Metformin). The tooth will be anesthetized using 2% lidocaine with 1:100000 adrenaline followed by rubber dam isolation. Caries excavation will be done and access cavity will be made. Coronal flaring & enlargement will be performed with rotary NiTi orifice enlargers to obtain straight -line access to the apical third of each root. Hand files No. 10, 15 and 20 will be used till working length (WL) to prepare a smooth reproducible glide path Working length will be obtained with the help of electronic apex locator (Root ZX) and confirmed radiographically. Canals will be then prepared using the Crown down technique with rotary instruments.

5ml of 5.25% sodium hypochlorite is used as irrigate after each instrument. After completion of canal instrumentation, all canal will be irrigated with 17% ethylenediamine-tetra acetic acid for 1 minute followed by a final irrigation with 5.0 ml of 5.25% sodium hypochlorite. Patency will maintained by placing a 10 k file 1 mm beyond the apical foramen after each instrument change. Canals will be dried with absorbent paper points and filled with a Calcium hydroxide with propylene glycol in control group A and will be filled with 1% Metformin with propylene glycol in control group B .Both paste will be paced in canal by lentulospiral and the access cavity restored with intermediate restorative material (IRM). The patient will be recalled after 1 week and evaluated for post operative pain.

At the next appointment, the paste will be removed with H- files and copious irrigation with 5.25% NaOCl; and dried with paper points. Canals will be obturated with the Gutta Percha and Zinc Oxide- Eugenol based sealer.

After obturation, the cavity will be restored . Immediate postoperative radiograph will then be taken. Follow up clinical and radiographic examinations will be carried out at 6 month & 12 month period.

Connect with a study center

  • Ambika Tekta

    Rohtak, Haryana 124001
    India

    Site Not Available

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