Clinical trial NCT04250519: 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
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Root Canal Infection
Lead sponsor: Tamil Nadu Dr.M.G.R.Medical University
Sponsor class: OTHER
First posted: 2020-01-31
Enrollment: 150
Sex: ALL
Minimum age (years): 15
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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. 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

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.

Primary outcomes:
measure: post operative pain evaluation using various combination of irrigants: VAS score
timeFrame: At 6 hours
measure: post operative pain evaluation using various combination of irrigants: VAS score
timeFrame: At 12 hours
measure: post operative pain evaluation using various combination of irrigants: VAS score
timeFrame: At 24 hours
measure: post operative pain evaluation using various combination of irrigants: VAS score
timeFrame: At 48 hours
measure: post operative pain evaluation using various combination of irrigants: VAS score
timeFrame: At 72 hours
measure: post operative pain evaluation using various combination of irrigants: VAS score
timeFrame: After 7 days
Secondary outcomes:
measure: assessment of other variables in pain scale
timeFrame: through study completion, an average of 1 week
measure: assessment of other variables in pain scale
timeFrame: through study completion, an average of 1 week
measure: assessment of other variables in pain scale
timeFrame: through study completion, an average of 1 week
Other outcomes:
Locations:
city: Madurai
country: India
facility: CSI college of dental sciences and research
state: Tamil Nadu
Study officials:
References: