Comparison of Postoperative Pain With or Without Apical Patency Technique in Asymptomatic Necrotic Teeth

NCT05574088 | Completed

• 1 other identifier: PrimeF
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Apical patency is a technique in which the apical portion of the canal is maintained free of soft tissue remnants and dentinal debris by recapitulation with a small #10k file through the apical foramen. The purpose of this study is to evaluate the association between apical patency and postoperative pain in teeth with asymptomatic necrotic pulp among patients attending the Peshawar Dental College and Hospital. This single center, double blinded prospective RCT study will be conducted in Peshawar Dental College and Hospital. The inclusion criteria will be mature maxillary and mandibular molars and premolars diagnosed with asymptomatic necrotic pulp and apical periodontitis among 18-60 aged male and female patients, whereas pregnant patients, individuals with previously accessed teeth, and those having positive history of analgesic use within past 3 days will be excluded from the study. A total of 60 patients, after an informed consent will be randomly allocated one of the two groups i.e., apical patency (AP)(n = 30) and the non-apical patency (NAP) (n = 30) in a ratio (1:1).After administering localanaesthesia, root canal preparation will be completed using ProTaper rotary instruments.A size 10 K-filewas carried 1 mm beyond the working length in the patency groupused as a patency file.Patients will be asked to mark their pain intensity on 0-10 scale (NRS)for 7 days. Data will be analyzed using ChiSquare test, Student t-test, Kolmogorov-Smirnov test.

Conditions

Pain, Postoperative; Acute Pain

Keywords

Apical patency; Asymptomatic necrotic teeth,; Postoperative pain

Outcome Measures

Primary Outcomes (1)

• COMPARISION OF POSTOPERATIVE PAIN WITH OR WITHOUT APICAL PATENCY TECHNQIUE IN ASYMPTOMATIC NECROTIC TEETH

  postoperative pain in patency and non patency groups will be measured and reported through Numerical rating scale from 0 to 10 for 7 days.

  Two months

Study Arms (2)

apical patency

EXPERIMENTAL

30 patients will be in apical patency group

Procedure: Apical patency with file

Control group ( non apical patency)

NO INTERVENTION

30 patients will be in control group ( non apical patency)

Interventions

Apical patency with file PROCEDURE

After an informed consent , One group will receive apical patency intervention with k file number 10 while the other will be control group

apical patency

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may not qualify if:

• whereas pregnant patients, individuals with previously accessed teeth, and those having positive history of analgesic use within past 3 days will be excluded from the study.

Sponsors & Collaborators

• Prime Foundation: lead

Study Sites (1)

Peshawar Dental College

Peshawar, Khyber Pakhtunkhwa, Pakistan

Location

MeSH Terms

Conditions

Pain, Postoperative; Acute Pain

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Rizwan Qureshi, BDS, FCPS

  Peshawar Dental College

  STUDY CHAIR

Study Design

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

Model Details: !) apical patency 2) Control group ( Non apical patency )

Study Record Dates

• First Submitted: September 16, 2022
• First Posted: October 10, 2022
• Study Start: September 1, 2022
• Primary Completion: October 25, 2022
• Study Completion: November 30, 2022
• Last Updated: March 29, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)