Single And Multiple-visit Endodontic Retreatment Outcome.

NCT ID: NCT04390789

Last Updated: 2020-05-18

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

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-15

Study Completion Date

2021-06-15

Brief Summary

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This study will compare the outcome of single visit retreatment and multi-visit retreatment in cases of failed root canal treated teeth.

Detailed Description

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Retreatment is defined as a procedure to remove root canal filling materials from the tooth, followed by cleaning, shaping and obturating the canals.Although initial root canal therapy has been shown to be a predictable procedure with a high degree of success, failures can occur after treatment. Recent publications have reported failure rates of 14%-16% for initial root canal treatment. In order to prevent tooth loss in such cases, nonsurgical retreatment or apical surgery is often indicated.

In this study subjects will be assigned to either the single-visit and multi-visit nonsurgical endodontic retreatment. The allocation will be performed once the chemomechanical preparation is completed.

Clinical and radiographic success rate will be considered as primary outcome. Follow up will be carried out every 3 months, till 12-month period.

Pain intensity will be considered as secondary outcome.

Conditions

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Apical Periodontitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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single visit retreatment

nonsurgical root canal retreatment will be carried out in single visit.

Group Type EXPERIMENTAL

Non surgical Single visit Retreatment

Intervention Type PROCEDURE

Non-surgical endodontic retreatment will be carried out in single visit.

multi visit retreatment

In this group,GP removal and biomechanical preparation will be carried out in first visit,after which calcium hydroxide dressing will be placed and temporarily restored.after 7 days,in second visit obturation will be done followed by permanent restoration

Group Type ACTIVE_COMPARATOR

Multi visit Retreatment with calcium hydroxide dressing

Intervention Type PROCEDURE

In this group,GP removal and biomechanical preparation will be carried out in first visit,after which calcium hydroxide dressing will be placed and temporarily restored.after 7 days,in second visit obturation will be done followed by permanent restoration

Interventions

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Non surgical Single visit Retreatment

Non-surgical endodontic retreatment will be carried out in single visit.

Intervention Type PROCEDURE

Multi visit Retreatment with calcium hydroxide dressing

In this group,GP removal and biomechanical preparation will be carried out in first visit,after which calcium hydroxide dressing will be placed and temporarily restored.after 7 days,in second visit obturation will be done followed by permanent restoration

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patient willingness to participate in the study.
* Previously root filled Permanent teeth with post-treatment apical periodontitis requiring nonsurgical root canal retreatment.
* Failure of previous root canal treatment will be determined based on clinical and radiographic findings. Clinical indicators of failure will include pain, tenderness to palpation/percussion, swelling, sinus tract.Radiographic criteria will include persistent periapical radiolucent lesions in teeth in which initial treatments were performed at least 4 years previously.
* Root canal fillings no more than 4mm short of the apex.
* Patients showing no significant systemic disease

Exclusion Criteria

* Patients who are pregnant, diabetic, immunocompromised, serious medical illness or requiring antibiotic premedication.
* Patient under 18 years of age.
* Patient under corticosteroid use.
* Patients with history of antibiotic use in last 3 months or analgesic use in last one week will also be excluded.
* Multiple teeth that require treatment to eliminate the possibility of pain referral.Patients with unrestorable carious lesions, fractures involving the periodontium, and/or periodontal pockets ≥ 4mm deep or having marginal or furcal bone loss due to periodontitis .
* Teeth with the procedural errors preventing access to apical third and missed canals will be excluded.
* Teeth that are not suitable for rubber dam isolation.
* Teeth with intraradicular post.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Postgraduate Institute of Dental Sciences Rohtak

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kajal Bhayani

Role: PRINCIPAL_INVESTIGATOR

POST GRADUATE INSTITUTE OF DENTAL SCIENCES, ROHTAK

Locations

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Post graduate institute of dental sciences

Rohtak, Haryana, India

Site Status RECRUITING

Sanjay Tewari

Rohtak, Haryana, India

Site Status RECRUITING

Countries

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India

Central Contacts

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Kajal Bhayani

Role: CONTACT

7507962278

DR PANKAJ SANGWAN

Role: CONTACT

9996112202

Facility Contacts

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Sanjay Tewari, MDS

Role: primary

01262283876

Sanjay TEWARI

Role: primary

9416259534

Other Identifiers

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Kajal Bhayani

Identifier Type: -

Identifier Source: org_study_id

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