"Effect of Apical Patency on Post-endodontic Pain"

NCT04551209 | Completed DMC

• 1 other identifier: 905/Trg-ABP1K2
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to find out the effect of maintaining apical patency versus non maintaining apical patency on post-operative pain after single visit endodontic treatment in necrotic teeth with asymptomatic apical periodontitis

Conditions

Apical Periodontitis

Outcome Measures

Primary Outcomes (1)

• Incidence of Post operative pain as determined by VAS (Visual Analogue Scale)

  To find out the incidence of post operative pain with Visual analogue scale after single visit endodontic treatment in necrotic teeth with asymptomatic apical periodontitis in two groups, Group A of 120 patients in which apical patency is maintained and Group B of 120 patients in which apical patency is non maintained. VAS (Visual Analogue Scale) will be used to measure pain. VAS scores of less than 4 will be considered as no pain, score of 4-7 will be considered as mild and/or moderate pain and scores of 8 and above will be considered as severe pain. (no pain = \<3, moderate pain = \>4 to 7, severe pain = \> 8).

  06 months

Study Arms (2)

Apical patency group

EXPERIMENTAL

Patients in which apical patency is maintained.

Procedure: Maintaining apical patency

Non- apical patency group

NO INTERVENTION

Patients in which apical patency is not maintained

Interventions

Maintaining apical patency PROCEDURE

In apical patency group, a size 10 K file will be passed beyond the apical foramen between each instrument change to maintain apical patency while in Non apical patency group, K file will be carried up to the working length only. A final peri-apical radiograph will be taken in the group A with the 10 K patency file 01mm beyond the apical foramen to confirm patency.

Apical patency group

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Necrotic Mandibular first molar teeth with asymptomatic apical periodontitis
• Mandibular first molar teeth without any intra-oral or extra-oral swelling or any draining sinus

You may not qualify if:

• Patients on preoperative analgesics and antibiotics
• Mandibular first molars with calcified canals and open apex
• Previously traumatized teeth and root canal treated teeth
• Immune-compromised patients
• pregnant and lactating mothers

Sponsors & Collaborators

• National University of Medical Sciences, Pakistan: lead

Study Sites (1)

Afid, Nums

Rawalpindi, Punjab Province, 46001, Pakistan

Location

MeSH Terms

Conditions

Periapical Periodontitis

Condition Hierarchy (Ancestors)

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

Study Officials

• Dil Rasheed

  AFID

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor / Consultant

Study Record Dates

• First Submitted: July 24, 2020
• First Posted: September 16, 2020
• Study Start: June 1, 2020
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: March 5, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)