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Single And Multiple-visit Endodontic Retreatment Outcome.

Primary Purpose

Apical Periodontitis

Status
Unknown status
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Non surgical Single visit Retreatment
Multi visit Retreatment with calcium hydroxide dressing
Sponsored by
Postgraduate Institute of Dental Sciences Rohtak
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Apical Periodontitis focused on measuring Nonsurgical Retreatment, Single Visit, Multi visit, Calcium Hydroxide, Outcome

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Post graduate institute of dental sciencesRecruiting
  • Sanjay TewariRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

single visit retreatment

multi visit retreatment

Arm Description

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

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

Outcomes

Primary Outcome Measures

Clinical and radiographic success
Criteria of clinical success: Absence of pain and tenderness to palpation/ percussion, absence of sinus or any associated soft tissue swelling, tooth mobility of grade-I or less, and no deterioration in periodontal probing depth as compared with baseline measurements Criteria of radiographic Success: PAI score 1-Normal periapical structures, OR PAI Score 2-Small changes in bone structure. Criteria of radiographic Failure: PAI score 3-Changes in bone structure with some mineral loss, OR PAI Score 4-Apical periodontitis with well-defined radiolucent area, OR PAI Score 5-Severe periodontitis with exacerbating features

Secondary Outcome Measures

Pain assessment
Visual analogue scale (VAS) from 0 to 10 will be used to record preoperative and post -operative pain.

Full Information

First Posted
May 13, 2020
Last Updated
May 14, 2020
Sponsor
Postgraduate Institute of Dental Sciences Rohtak
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1. Study Identification

Unique Protocol Identification Number
NCT04390789
Brief Title
Single And Multiple-visit Endodontic Retreatment Outcome.
Official Title
Outcome Following Single-visit And Multiple-visit Nonsurgical Endodontic Retreatment
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 15, 2019 (Actual)
Primary Completion Date
June 15, 2020 (Anticipated)
Study Completion Date
June 15, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Postgraduate Institute of Dental Sciences Rohtak

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Apical Periodontitis
Keywords
Nonsurgical Retreatment, Single Visit, Multi visit, Calcium Hydroxide, Outcome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
single visit retreatment
Arm Type
Experimental
Arm Description
nonsurgical root canal retreatment will be carried out in single visit.
Arm Title
multi visit retreatment
Arm Type
Active Comparator
Arm Description
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
Intervention Name(s)
Non surgical Single visit Retreatment
Intervention Description
Non-surgical endodontic retreatment will be carried out in single visit.
Intervention Type
Procedure
Intervention Name(s)
Multi visit Retreatment with calcium hydroxide dressing
Intervention Description
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
Primary Outcome Measure Information:
Title
Clinical and radiographic success
Description
Criteria of clinical success: Absence of pain and tenderness to palpation/ percussion, absence of sinus or any associated soft tissue swelling, tooth mobility of grade-I or less, and no deterioration in periodontal probing depth as compared with baseline measurements Criteria of radiographic Success: PAI score 1-Normal periapical structures, OR PAI Score 2-Small changes in bone structure. Criteria of radiographic Failure: PAI score 3-Changes in bone structure with some mineral loss, OR PAI Score 4-Apical periodontitis with well-defined radiolucent area, OR PAI Score 5-Severe periodontitis with exacerbating features
Time Frame
Baseline to 1 year
Secondary Outcome Measure Information:
Title
Pain assessment
Description
Visual analogue scale (VAS) from 0 to 10 will be used to record preoperative and post -operative pain.
Time Frame
Baseline to 7days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kajal Bhayani
Phone
7507962278
Email
bhayanikajal@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
DR PANKAJ SANGWAN
Phone
9996112202
Email
drps_1@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kajal Bhayani
Organizational Affiliation
POST GRADUATE INSTITUTE OF DENTAL SCIENCES, ROHTAK
Official's Role
Principal Investigator
Facility Information:
Facility Name
Post graduate institute of dental sciences
City
Rohtak
State/Province
Haryana
ZIP/Postal Code
124001
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sanjay Tewari, MDS
Phone
01262283876
Email
principalpgids@yahoo.in
Facility Name
Sanjay Tewari
City
Rohtak
State/Province
Haryana
ZIP/Postal Code
124001
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sanjay TEWARI
Phone
9416259534
Email
principalpgids@yahoo.in

12. IPD Sharing Statement

Plan to Share IPD
No

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Single And Multiple-visit Endodontic Retreatment Outcome.

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