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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Root Canal Infection

Intervention / Treatment
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* Drug: Sodium Hypochlorite


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 |