search
Back to results

Evaluation of Post Operative Pain in Retreatment of Molars Using Different Irrigant

Primary Purpose

Root Canal Infection

Status
Unknown status
Phase
Phase 1
Locations
India
Study Type
Interventional
Intervention
Sodium Hypochlorite
Sponsored by
Tamil Nadu Dr.M.G.R.Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Root Canal Infection

Eligibility Criteria

15 Years - 70 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • teeth previously treated or attempted root canal treatment,
  • teeth with or without symptoms,
  • periapical radiograph showing evidence of inadequate previous root canal treatment or periapical changes,
  • only teeth or at least one canal where complete removal of root canal filling material was possible and reach the working length in first appointment.

Exclusion Criteria:

  • patient not willing for follow up,
  • teeth with extensive cervical or apical resorption that restricted the use of sodium hypochlorite irrigation,
  • teeth with poor periodontal status, teeth not suitable for post endodontic restoration,
  • patients with acute periapical abscess,
  • patients with systemic conditions preventing radiograph exposure or multi visit treatment,
  • pregnant patients,
  • patients with allergy to any known dental materials.

Sites / Locations

  • CSI college of dental sciences and researchRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

1% sodium hypochlorite & dexamethasone 4mg as irrigants

1% sodium hypochlorite as irrigant &normal saline as placebo

5.25% sodium hypochlorite and dexamethasone 4mg as irrigants

5.25% sodium hypochlorite &normal saline as placebo

Arm Description

sodium hypochlorite is effective in any concentration as antimicrobial irrigant and dexamethasone is anti inflammatory drug

sodium hypochlorite is effective in any concentration as irrigant

sodium hypochlorite is effective in any concentration as antimicrobial irrigant and dexamethasone is anti inflammatory drug

sodium hypochlorite is effective in any concentration as irrigant

Outcomes

Primary Outcome Measures

post operative pain evaluation using various combination of irrigants: VAS score
pain scale is evaluated using VISUAL ANALOG SCALE (VAS) score (1-10) 1 is minimum amount of pain experienced and 10 is maximum amount of pain experienced [1-3] mild pain , [4-7] moderate pain , [8-10] severe pain .
post operative pain evaluation using various combination of irrigants: VAS score
pain scale is evaluated using VISUAL ANALOG SCALE (VAS) score (1-10) 1 is minimum amount of pain experienced and 10 is maximum amount of pain experienced [1-3] mild pain , [4-7] moderate pain , [8-10] severe pain .
post operative pain evaluation using various combination of irrigants: VAS score
pain scale is evaluated using VISUAL ANALOG SCALE (VAS) score (1-10) 1 is minimum amount of pain experienced and 10 is maximum amount of pain experienced [1-3] mild pain , [4-7] moderate pain , [8-10] severe pain .
post operative pain evaluation using various combination of irrigants: VAS score
pain scale is evaluated using VISUAL ANALOG SCALE (VAS) score (1-10) 1 is minimum amount of pain experienced and 10 is maximum amount of pain experienced [1-3] mild pain , [4-7] moderate pain , [8-10] severe pain .
post operative pain evaluation using various combination of irrigants: VAS score
pain scale is evaluated using VISUAL ANALOG SCALE (VAS) score (1-10) 1 is minimum amount of pain experienced and 10 is maximum amount of pain experienced [1-3] mild pain , [4-7] moderate pain , [8-10] severe pain .
post operative pain evaluation using various combination of irrigants: VAS score
pain scale is evaluated using VISUAL ANALOG SCALE (VAS) score (1-10) 1 is minimum amount of pain experienced and 10 is maximum amount of pain experienced [1-3] mild pain , [4-7] moderate pain , [8-10] severe pain .

Secondary Outcome Measures

assessment of other variables in pain scale
comparing the pain scale experienced between male and female in VAS score
assessment of other variables in pain scale
comparing the pain scale experienced between mandibular molar and maxillary molar from VAS score
assessment of other variables in pain scale
comparing the pain scale based on patients pre operative symptom ex; patient is symptomatic or Asymptomatic before treatment procedure

Full Information

First Posted
January 22, 2020
Last Updated
May 6, 2020
Sponsor
Tamil Nadu Dr.M.G.R.Medical University
search

1. Study Identification

Unique Protocol Identification Number
NCT04250519
Brief Title
Evaluation of Post Operative Pain in Retreatment of Molars Using Different Irrigant
Official Title
Assessment of Post Operative Pain Following Root Canal Retreatment in Molars Using Four Different Combination of Irrigants : A Prospective Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 3, 2020 (Actual)
Primary Completion Date
February 15, 2021 (Anticipated)
Study Completion Date
April 15, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tamil Nadu Dr.M.G.R.Medical University

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
No

5. Study Description

Brief Summary
This study evaluates the efficacy of dexamethasone as a intracanal irrigant along with sodium hypochlorite 1% and 5.25% concentrations in post treatment pain for molar root canal retreatment.
Detailed Description
Main objective of root canal retreatment is to alleviate pain and disinfect the rootcanal .However some patients may experience mild to severe pain following treatment , which leads to intake of painkillers orally for post operative pain management. So , this study evaluates the efficiency of dexamethasone used as intracanal irrigant in post treatment pain for molar root canal retreatment sodium hypochlorite (1% &5.25%) is used for disinfecting the canals patients will be grouped into Symptomatic and Asymptomatic patients requiring root canal retreatment and irrigants will be used in various combinations as mentioned below 1% sodium hypochlorite alone 2.5ml in each canal along with ultrasonic activation 1% sodium hypochlorite and dexamethasone 4mg,2.5ml in each canal along with ultrasonic activation 5.25% sodium hypochlorite alone 2.5ml in each canal along with ultrasonic activation 5.25% sodium hypochlorite and dexamethasone 4mg, 2.5ml in each canal along with ultrasonic activation calcium hydroxide is commonly used as intracanal medicament in all the patients post operative symptoms is evaluated at 12 hrs , 24 hrs,48 hrs, 72 hrs and 1 week followed by obturation is completed

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Root Canal Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1% sodium hypochlorite & dexamethasone 4mg as irrigants
Arm Type
Experimental
Arm Description
sodium hypochlorite is effective in any concentration as antimicrobial irrigant and dexamethasone is anti inflammatory drug
Arm Title
1% sodium hypochlorite as irrigant &normal saline as placebo
Arm Type
Active Comparator
Arm Description
sodium hypochlorite is effective in any concentration as irrigant
Arm Title
5.25% sodium hypochlorite and dexamethasone 4mg as irrigants
Arm Type
Experimental
Arm Description
sodium hypochlorite is effective in any concentration as antimicrobial irrigant and dexamethasone is anti inflammatory drug
Arm Title
5.25% sodium hypochlorite &normal saline as placebo
Arm Type
Active Comparator
Arm Description
sodium hypochlorite is effective in any concentration as irrigant
Intervention Type
Drug
Intervention Name(s)
Sodium Hypochlorite
Intervention Description
Sodium hypochlorite is used as intracanal irrigant to minimize the post operative pain
Primary Outcome Measure Information:
Title
post operative pain evaluation using various combination of irrigants: VAS score
Description
pain scale is evaluated using VISUAL ANALOG SCALE (VAS) score (1-10) 1 is minimum amount of pain experienced and 10 is maximum amount of pain experienced [1-3] mild pain , [4-7] moderate pain , [8-10] severe pain .
Time Frame
At 6 hours
Title
post operative pain evaluation using various combination of irrigants: VAS score
Description
pain scale is evaluated using VISUAL ANALOG SCALE (VAS) score (1-10) 1 is minimum amount of pain experienced and 10 is maximum amount of pain experienced [1-3] mild pain , [4-7] moderate pain , [8-10] severe pain .
Time Frame
At 12 hours
Title
post operative pain evaluation using various combination of irrigants: VAS score
Description
pain scale is evaluated using VISUAL ANALOG SCALE (VAS) score (1-10) 1 is minimum amount of pain experienced and 10 is maximum amount of pain experienced [1-3] mild pain , [4-7] moderate pain , [8-10] severe pain .
Time Frame
At 24 hours
Title
post operative pain evaluation using various combination of irrigants: VAS score
Description
pain scale is evaluated using VISUAL ANALOG SCALE (VAS) score (1-10) 1 is minimum amount of pain experienced and 10 is maximum amount of pain experienced [1-3] mild pain , [4-7] moderate pain , [8-10] severe pain .
Time Frame
At 48 hours
Title
post operative pain evaluation using various combination of irrigants: VAS score
Description
pain scale is evaluated using VISUAL ANALOG SCALE (VAS) score (1-10) 1 is minimum amount of pain experienced and 10 is maximum amount of pain experienced [1-3] mild pain , [4-7] moderate pain , [8-10] severe pain .
Time Frame
At 72 hours
Title
post operative pain evaluation using various combination of irrigants: VAS score
Description
pain scale is evaluated using VISUAL ANALOG SCALE (VAS) score (1-10) 1 is minimum amount of pain experienced and 10 is maximum amount of pain experienced [1-3] mild pain , [4-7] moderate pain , [8-10] severe pain .
Time Frame
After 7 days
Secondary Outcome Measure Information:
Title
assessment of other variables in pain scale
Description
comparing the pain scale experienced between male and female in VAS score
Time Frame
through study completion, an average of 1 week
Title
assessment of other variables in pain scale
Description
comparing the pain scale experienced between mandibular molar and maxillary molar from VAS score
Time Frame
through study completion, an average of 1 week
Title
assessment of other variables in pain scale
Description
comparing the pain scale based on patients pre operative symptom ex; patient is symptomatic or Asymptomatic before treatment procedure
Time Frame
through study completion, an average of 1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: teeth previously treated or attempted root canal treatment, teeth with or without symptoms, periapical radiograph showing evidence of inadequate previous root canal treatment or periapical changes, only teeth or at least one canal where complete removal of root canal filling material was possible and reach the working length in first appointment. Exclusion Criteria: patient not willing for follow up, teeth with extensive cervical or apical resorption that restricted the use of sodium hypochlorite irrigation, teeth with poor periodontal status, teeth not suitable for post endodontic restoration, patients with acute periapical abscess, patients with systemic conditions preventing radiograph exposure or multi visit treatment, pregnant patients, patients with allergy to any known dental materials.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Valliappan C.T, post graduate (MDS)
Phone
8870558925
Ext
8248785715
Email
vrvalliappan2@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Anand Sherwood, MDS, Ph.D
Phone
9791443950
Email
anand.sherwood@gmail.com
Facility Information:
Facility Name
CSI college of dental sciences and research
City
Madurai
State/Province
Tamil Nadu
ZIP/Postal Code
625001
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anand Sherwood
Phone
9791443950
Email
anand.sherwood@gmail.com
First Name & Middle Initial & Last Name & Degree
Valliappan C.T, post graduate

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Time Frame
from may 2021 and available till may 2025

Learn more about this trial

Evaluation of Post Operative Pain in Retreatment of Molars Using Different Irrigant

We'll reach out to this number within 24 hrs