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

NCT ID: NCT04250519

Last Updated: 2020-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-03

Study Completion Date

2021-04-15

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. 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

Conditions

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Root Canal Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1% sodium hypochlorite & dexamethasone 4mg as irrigants

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

Group Type EXPERIMENTAL

Sodium Hypochlorite

Intervention Type DRUG

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

1% sodium hypochlorite as irrigant &normal saline as placebo

sodium hypochlorite is effective in any concentration as irrigant

Group Type ACTIVE_COMPARATOR

Sodium Hypochlorite

Intervention Type DRUG

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

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

Group Type EXPERIMENTAL

Sodium Hypochlorite

Intervention Type DRUG

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

5.25% sodium hypochlorite &normal saline as placebo

sodium hypochlorite is effective in any concentration as irrigant

Group Type ACTIVE_COMPARATOR

Sodium Hypochlorite

Intervention Type DRUG

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

Interventions

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Sodium Hypochlorite

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

Intervention Type DRUG

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.
Minimum Eligible Age

15 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tamil Nadu Dr.M.G.R.Medical University

OTHER

Sponsor Role lead

Responsible Party

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Dr. CT. VALLIAPPAN

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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CSI college of dental sciences and research

Madurai, Tamil Nadu, India

Site Status RECRUITING

Countries

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India

Central Contacts

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Valliappan C.T, post graduate (MDS)

Role: CONTACT

8870558925 ext. 8248785715

Anand Sherwood, MDS, Ph.D

Role: CONTACT

9791443950

Facility Contacts

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Anand Sherwood

Role: primary

9791443950

Other Identifiers

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TamilNaduMU

Identifier Type: -

Identifier Source: org_study_id

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