Comparison of Post-operative Pain Frequency

NCT04944589 | Completed DMC

• 1 other identifier: 14345
• Study Type: interventional
• Target: 302
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is:

• To compare the post-operative pain frequency after single visit root canal versus multiple visit root canal treatment in patients with non-vital teeth
• Post-operative pain is less frequent after single visit root canal than multiple visit root canal treatment in patients with non-vital teeth.

Conditions

Pain, Postoperative

Keywords

Endodontics, Non-vital teeth, Post-operative pain

Outcome Measures

Primary Outcomes (1)

• Comprision of Post-Operative pain Frequency

  After obturation, the patients in both the groups were recalled after 48 hours and assessed using visual analogue scale regarding presence and absence of post-operative pain. A value of 0-1 on VAS scale was considered as absence of pain

  6 months

Study Arms (2)

single visit root canal treatment(RCT)

EXPERIMENTAL

RCT(ROOT CANAL TREATMENT) of this group was performed in single visit including access cavity, chemo-mechanical preparation and obturation, all were done in one visit

Procedure: ROOT CANAL TREATMENT

Multiple visit root canal treatment(RCT)

EXPERIMENTAL

RCT(ROOT CANAL TREATMENT) of this group was performed in multiple visit including access cavity, chemo-mechanical preparation and obturation, all were done in two or three visits

Procedure: ROOT CANAL TREATMENT

Interventions

ROOT CANAL TREATMENT PROCEDURE

Clinical endodontics involved in the goal of preventing and treating microbial contamination of pulps comprises of a number of treatments. Root canal endodontic therapy has one specific set of aims: to cure or prevent peri-radicular periodontitis, to conserve their natural teeth in function and aesthetics.

Multiple visit root canal treatment(RCT); single visit root canal treatment(RCT)

Eligibility Criteria

• Age: 20 Years - 40 Years
• Gender Eligibility Details: Patients within age range 20-40 years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients within age range 20-40 years.
• Male/Female
• Mature permanent first and second molar teeth (maxillary and mandibular)
• Non-vital teeth (As defined in operational definitions)

You may not qualify if:

• Any contraindication to local anesthesia, e.g. known allergy
• Pregnancy.
• endodontic re-treatment cases
• Any physical or mental condition that would prevent jaw opening for the time required to complete the treatment.
• Local acute infection/periapical radiolucency (diagnosed clinically, radio graphically )

Sponsors & Collaborators

• Fatima Memorial Hospital: lead

Study Sites (1)

Huma Tanvir

Lahore, Punjab Province, 53000, Pakistan

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

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

Study Officials

• Huma Tanvir, BDS

  Fatima Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: : This study was a randomized controlled trial conducted at Department of Operative Dentistry, Fatima Memorial Hospital, Lahore, over a period of six months. A total of 302 patients presented with pulp necrosis in mandibular and maxillary first and second molar were included in this study and divided in two groups of 151. RCT of Group A patients was performed in single visit and RCT of group B patients was performed in multiple visits

Study Record Dates

• First Submitted: June 18, 2021
• First Posted: June 29, 2021
• Study Start: March 9, 2019
• Primary Completion: February 28, 2020
• Study Completion: February 28, 2020
• Last Updated: June 29, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)