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

Root Canal Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04250519
• Other study ID #: TamilNaduMU
• Status: Recruiting
• Phase: Phase 1
• Start date: February 3, 2020
• Est. completion date: April 15, 2021

Study information

• Verified date: May 2020
• Source: Tamil Nadu Dr.M.G.R.Medical University
• Contact: Valliappan C.T, post graduate (MDS)
• Phone: 8870558925
• Email: vrvalliappan2[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: April 15, 2021
• Est. primary completion date: February 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative
• Root Canal Infection

Intervention

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

Locations

Country	Name	City	State
India	CSI college of dental sciences and research	Madurai	Tamil Nadu

Sponsors (1)

Lead Sponsor	Collaborator
Tamil Nadu Dr.M.G.R.Medical University

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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