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Comparison of Post-operative Pain Frequency

Primary Purpose

Pain, Postoperative

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
ROOT CANAL TREATMENT
Sponsored by
Fatima Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative focused on measuring Endodontics, Non-vital teeth, Post-operative pain

Eligibility Criteria

20 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • • 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)

Exclusion Criteria:

  • • 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 )

Sites / Locations

  • Huma Tanvir

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

single visit root canal treatment(RCT)

Multiple visit root canal treatment(RCT)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 18, 2021
Last Updated
June 22, 2021
Sponsor
Fatima Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04944589
Brief Title
Comparison of Post-operative Pain Frequency
Official Title
Comparison of Post-operative Pain Frequency in Non-vital Teeth After Single Visit Root Canal Versus Multiple Visit Root Canal Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
March 9, 2019 (Actual)
Primary Completion Date
February 28, 2020 (Actual)
Study Completion Date
February 28, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fatima Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
METHODOLOGY This Randomized control trial was done in Outdoor patients Department of Operative Dentistry at Fatima Memorial Hospital. Informed written consent was taken from all patients who were willing to participate in the study. Patients who were diagnosed with non-vital teeth were considered for this study. Socio-demographic data and symptoms were recorded, subjects were examined and relevant investigations (vitality tests and radiographs) carried out. The patients were randomly divided into two groups through lottery method. Group A the treatment was done in one visit while in group B treatment was completed in two visits. The standard procedure for both groups at first visit was administration of local anesthesia (1.8ml 2% Lignocaine with 1:10000 epinephrine), standard access cavity preparation followed by rubber dam isolation and pulp extirpation. After the confirmation of canal patency and working length radiograph, canals were prepared with the combination of hand files and engine-driven rotary nickel-titanium files (DENTSPLY Maillefer, Ballaigues, Switzerland) following manufacturer's instructions. 17%Ethylenediaminetetraacetic acid (EDTA )gel was used as a lubricant. Irrigation was performed with 2.5% NaOCl after each instrument in all cases. At the first visit, all teeth were prepared to working length and dried with paper points. Canals in Group A were filled with protaper universal gutta-percha (DENTSPLY Maillefer) and calcium hydroxide based sealer and restored with permanent restorative material in the same visit. In Group B after the canal preparation non-setting calcium hydroxide paste was placed with a sterile dry cotton pellet in the canal and tooth was restored with a minimum of 3.0mm Cavit. Patients in Group 2 were recalled after 1 week and the obturation technique same as Group 1 was followed in the second visit. 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 Visual Analogue Scale (VAS) scale was considered as absence of pain. The data was entered and analyzed in the SPSS-20. For descriptive analysis, mean and standard deviation was reported for age. Percentage for male and female participants was presented for gender distribution. The incidence of post-operative pain for single visit root canal and multiple visit root canal was determined. A chi-square test was used to determine the frequency of post-operative pain in both groups. A P value of 0.05 or less was taken as significant. Data was stratified more scientific manner in Pakistani population. So, the results of this study would add to the literature about the better, time saving and less painful (ROOT CANAL TREATMENT)RCT strategy in term of post- operative pain management.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
Endodontics, Non-vital teeth, Post-operative pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
: 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
Masking
Investigator
Allocation
Randomized
Enrollment
302 (Actual)

8. Arms, Groups, and Interventions

Arm Title
single visit root canal treatment(RCT)
Arm Type
Experimental
Arm Description
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
Arm Title
Multiple visit root canal treatment(RCT)
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
ROOT CANAL TREATMENT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Comprision of Post-Operative pain Frequency
Description
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
Time Frame
6 months

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
Patients within age range 20-40 years
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: • 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) Exclusion Criteria: • 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 )
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huma Tanvir, BDS
Organizational Affiliation
Fatima Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Huma Tanvir
City
Lahore
State/Province
Punjab
ZIP/Postal Code
53000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

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Comparison of Post-operative Pain Frequency

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