Postoperative Pain and Incidence of Extrusion Following the Use of Two Intra-canal Medications in Retreatment of Single Rooted Teeth

NCT06913673 | Not Yet Recruiting Phase 2

• 1 other identifier: 1026/114
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to compare the postoperative pain and incidence of extrusion of two intracanal medications in the retreatment of single-rooted teeth. The main question it aims to answer is: Does the injection of intra-canal medication into the shaped root canal after complete removal of the old obturating material lead to post-operative pain and paste extrusion to periapical tissues or not?

Conditions

Endodontic Disease

Outcome Measures

Primary Outcomes (2)

• Clinical assessment of the post retreatment pain.

  Pain scores will be recorded on visual analog scale (VAS) using a 0 to 10 pain score basis with 0 being no pain and 10 being the worst pain the patient had ever experienced. (Record will be every 24h for 7 days)

  One week after re-treatment procdure

• Radiographic assessment of the extrusion of the paste into periapical tissues using Digital radiograph

  Extrusion of the paste into periapical incidence of extrusion: Conventional digital radiograph will be taken after using intracanal medication pastes.

  Immediate after retreatment

Study Arms (2)

Group A: Metapex

EXPERIMENTAL

Non- surgical root canal retreatment with application of Metapex in to root canal after complete removal of the old obturation material.

Other: Metapex

Group A:Bio-c Temp

EXPERIMENTAL

Non- surgical root canal retreatment with application of Bio-c Temp paste in to root canal after complete removal of the old obturation material.

Other: Bio-c Temp

Interventions

Bio-c Temp OTHER

Intra-canal medication

Group A:Bio-c Temp

Metapex OTHER

Intra-canal medication

Group A: Metapex

Eligibility Criteria

• Age: 16 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients with failed endodontic treatment in single root teeth
• Systemic free

You may not qualify if:

• Muktirooted teeth

Sponsors & Collaborators

• Minia University: lead

MeSH Terms

Conditions

Dental Pulp Diseases

Interventions

Metapex

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

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: lecturer in endodontics

Study Record Dates

• First Submitted: March 20, 2025
• First Posted: April 6, 2025
• Study Start: April 1, 2025
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: April 6, 2025

Record last verified: 2025-04