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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: February 15, 2021

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

Interventions

  • Drug: Sodium Hypochlorite
    • Sodium hypochlorite is used as intracanal irrigant to minimize the post operative pain

Arms, Groups and Cohorts

  • Experimental: 1% sodium hypochlorite & dexamethasone 4mg as irrigants
    • sodium hypochlorite is effective in any concentration as antimicrobial irrigant and dexamethasone is anti inflammatory drug
  • Active Comparator: 1% sodium hypochlorite as irrigant &normal saline as placebo
    • sodium hypochlorite is effective in any concentration as irrigant
  • 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
  • Active Comparator: 5.25% sodium hypochlorite &normal saline as placebo
    • sodium hypochlorite is effective in any concentration as irrigant

Clinical Trial Outcome Measures

Primary Measures

  • post operative pain evaluation using various combination of irrigants: VAS score
    • Time Frame: At 6 hours
    • 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
    • Time Frame: At 12 hours
    • 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
    • Time Frame: At 24 hours
    • 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
    • Time Frame: At 48 hours
    • 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
    • Time Frame: At 72 hours
    • 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
    • Time Frame: After 7 days
    • 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 Measures

  • assessment of other variables in pain scale
    • Time Frame: through study completion, an average of 1 week
    • comparing the pain scale experienced between male and female in VAS score
  • assessment of other variables in pain scale
    • Time Frame: through study completion, an average of 1 week
    • comparing the pain scale experienced between mandibular molar and maxillary molar from VAS score
  • assessment of other variables in pain scale
    • Time Frame: through study completion, an average of 1 week
    • comparing the pain scale based on patients pre operative symptom ex; patient is symptomatic or Asymptomatic before treatment procedure

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 15 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Tamil Nadu Dr.M.G.R.Medical University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Dr. CT. VALLIAPPAN, Principal Investigator – Tamil Nadu Dr.M.G.R.Medical University
  • Overall Contact(s)
    • Valliappan C.T, post graduate (MDS), 8870558925, vrvalliappan2@gmail.com

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