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

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ClinicalTrials.gov Identifier: NCT04250519
Recruitment Status : Unknown
Verified May 2020 by Dr. CT. VALLIAPPAN, Tamil Nadu Dr.M.G.R.Medical University.
Recruitment status was:  Recruiting
First Posted : January 31, 2020
Last Update Posted : May 7, 2020
Sponsor:
Information provided by (Responsible Party):
Dr. CT. VALLIAPPAN, Tamil Nadu Dr.M.G.R.Medical University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Root Canal Infection Drug: Sodium Hypochlorite Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Assessment of Post Operative Pain Following Root Canal Retreatment in Molars Using Four Different Combination of Irrigants : A Prospective Clinical Study
Actual Study Start Date : February 3, 2020
Estimated Primary Completion Date : February 15, 2021
Estimated Study Completion Date : April 15, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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 .

  2. 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 .

  3. 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 .

  4. 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 .

  5. 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 .

  6. 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 Outcome Measures :
  1. 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

  2. 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

  3. 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


Eligibility Criteria
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Ages Eligible for Study:   15 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04250519


Contacts
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Contact: Valliappan C.T, post graduate (MDS) 8870558925 ext 8248785715 vrvalliappan2@gmail.com
Contact: Anand Sherwood, MDS, Ph.D 9791443950 anand.sherwood@gmail.com

Locations
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India
CSI college of dental sciences and research Recruiting
Madurai, Tamil Nadu, India, 625001
Contact: Anand Sherwood    9791443950    anand.sherwood@gmail.com   
Principal Investigator: Valliappan C.T, post graduate         
Sponsors and Collaborators
Tamil Nadu Dr.M.G.R.Medical University
More Information
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Responsible Party: Dr. CT. VALLIAPPAN, Principal Investigator, Tamil Nadu Dr.M.G.R.Medical University
ClinicalTrials.gov Identifier: NCT04250519    
Other Study ID Numbers: TamilNaduMU
First Posted: January 31, 2020    Key Record Dates
Last Update Posted: May 7, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Clinical Study Report (CSR)
Time Frame: from may 2021 and available till may 2025

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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
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
 Sodium Hypochlorite
Eusol
Disinfectants
Anti-Infective Agents