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

Assessment of Post Operative Pain Following Root Canal Retreatment in Molars Using Four Different Combination of Irrigants : A Prospective Clinical Study

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.

Study Overview

• Status: Unknown
• Conditions: Root Canal Infection
• Intervention / Treatment: Drug: Sodium Hypochlorite

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. 1% sodium hypochlorite alone 2.5ml in each canal along with ultrasonic activation
2. 1% sodium hypochlorite and dexamethasone 4mg,2.5ml in each canal along with ultrasonic activation
3. 5.25% sodium hypochlorite alone 2.5ml in each canal along with ultrasonic activation
4. 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

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Anand Sherwood, MDS, Ph.D; Phone Number: 9791443950; Email: anand.sherwood@gmail.com
• Study Contact Backup: Name: Valliappan C.T, post graduate (MDS); Phone Number: 8248785715 8870558925; Email: vrvalliappan2@gmail.com

Study Locations

• India
  • Tamil Nadu
    • Madurai, Tamil Nadu, India, 625001
      • Recruiting
      • CSI College of Dental Sciences and Research
      • Contact: Anand Sherwood; Phone Number: 9791443950; Email: anand.sherwood@gmail.com
      • Principal Investigator: Valliappan C.T, post graduate

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 70 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1% sodium hypochlorite & dexamethasone 4mg as irrigants; sodium hypochlorite is effective in any concentration as antimicrobial irrigant and dexamethasone is anti inflammatory drug	Drug: Sodium Hypochlorite; Sodium hypochlorite is used as intracanal irrigant to minimize the post operative pain
Active Comparator: 1% sodium hypochlorite as irrigant &normal saline as placebo; sodium hypochlorite is effective in any concentration as irrigant	Drug: Sodium Hypochlorite; Sodium hypochlorite is used as intracanal irrigant to minimize the post operative pain
Experimental: 5.25% sodium hypochlorite and dexamethasone 4mg as irrigants; sodium hypochlorite is effective in any concentration as antimicrobial irrigant and dexamethasone is anti inflammatory drug	Drug: Sodium Hypochlorite; Sodium hypochlorite is used as intracanal irrigant to minimize the post operative pain
Active Comparator: 5.25% sodium hypochlorite &normal saline as placebo; sodium hypochlorite is effective in any concentration as irrigant	Drug: Sodium Hypochlorite; Sodium hypochlorite is used as intracanal irrigant to minimize the post operative pain

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 .	At 6 hours
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 .	At 12 hours
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 .	At 24 hours
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 .	At 48 hours
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 .	At 72 hours
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 .	After 7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
assessment of other variables in pain scale	comparing the pain scale experienced between male and female in VAS score	through study completion, an average of 1 week
assessment of other variables in pain scale	comparing the pain scale experienced between mandibular molar and maxillary molar from VAS score	through study completion, an average of 1 week
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	through study completion, an average of 1 week

Collaborators and Investigators

• Sponsor: Tamil Nadu Dr.M.G.R.Medical University

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2020
• Primary Completion (Anticipated): February 15, 2021
• Study Completion (Anticipated): April 15, 2021

Study Registration Dates

• First Submitted: January 22, 2020
• First Submitted That Met QC Criteria: January 30, 2020
• First Posted (Actual): January 31, 2020

Study Record Updates

• Last Update Posted (Actual): May 7, 2020
• Last Update Submitted That Met QC Criteria: May 6, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Anti-Infective Agents; Disinfectants; Sodium Hypochlorite; Eusol
• Other Study ID Numbers: TamilNaduMU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: from may 2021 and available till may 2025
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• 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