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

NCT04250519 | Unknown Phase 1

• 1 other identifier: TamilNaduMU
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Root Canal Infection

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (3)

• assessment of other variables in pain scale

  through study completion, an average of 1 week

• assessment of other variables in pain scale

  through study completion, an average of 1 week

• assessment of other variables in pain scale

  through study completion, an average of 1 week

Study Arms (4)

1% sodium hypochlorite & dexamethasone 4mg as irrigants

EXPERIMENTAL

sodium hypochlorite is effective in any concentration as antimicrobial irrigant and dexamethasone is anti inflammatory drug

Drug: Sodium Hypochlorite

1% sodium hypochlorite as irrigant &normal saline as placebo

ACTIVE COMPARATOR

sodium hypochlorite is effective in any concentration as irrigant

Drug: Sodium Hypochlorite

5.25% sodium hypochlorite and dexamethasone 4mg as irrigants

EXPERIMENTAL

sodium hypochlorite is effective in any concentration as antimicrobial irrigant and dexamethasone is anti inflammatory drug

Drug: Sodium Hypochlorite

5.25% sodium hypochlorite &normal saline as placebo

ACTIVE COMPARATOR

sodium hypochlorite is effective in any concentration as irrigant

Drug: Sodium Hypochlorite

Interventions

Sodium Hypochlorite DRUG

Sodium hypochlorite is used as intracanal irrigant to minimize the post operative pain

1% sodium hypochlorite & dexamethasone 4mg as irrigants; 1% sodium hypochlorite as irrigant &normal saline as placebo; 5.25% sodium hypochlorite &normal saline as placebo; 5.25% sodium hypochlorite and dexamethasone 4mg as irrigants

Eligibility Criteria

• Age: 15 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tamil Nadu Dr.M.G.R.Medical University: lead

Study Sites (1)

CSI college of dental sciences and research

Madurai, Tamil Nadu, 625001, India

RECRUITING

MeSH Terms

Interventions

Sodium Hypochlorite

Intervention Hierarchy (Ancestors)

Hypochlorous Acid; Chlorine Compounds; Inorganic Chemicals; Oxides; Oxygen Compounds; Sodium Compounds

Central Study Contacts

Valliappan C.T, post graduate (MDS)

CONTACT

8870558925; vrvalliappan2@gmail.com

Anand Sherwood, MDS, Ph.D

CONTACT

9791443950; anand.sherwood@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 22, 2020
• First Posted: January 31, 2020
• Study Start: February 3, 2020
• Primary Completion: February 15, 2021
• Study Completion: April 15, 2021
• Last Updated: May 7, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: from may 2021 and available till may 2025

Locations

IN (1)