- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04390789
Single And Multiple-visit Endodontic Retreatment Outcome.
Outcome Following Single-visit And Multiple-visit Nonsurgical Endodontic Retreatment
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Kajal Bhayani
- Phone Number: 7507962278
- Email: bhayanikajal@gmail.com
Study Locations
-
-
Haryana
-
Rohtak, Haryana, India, 124001
- Recruiting
- Post Graduate Institute of Dental Sciences
-
Rohtak, Haryana, India, 124001
- Recruiting
- Sanjay Tewari
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: single visit retreatment
nonsurgical root canal retreatment will be carried out in single visit.
|
Non-surgical endodontic retreatment will be carried out in single visit.
|
ACTIVE_COMPARATOR: 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
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical and radiographic success
Time Frame: Baseline to 1 year
|
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 |
Baseline to 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain assessment
Time Frame: Baseline to 7days
|
Visual analogue scale (VAS) from 0 to 10 will be used to record preoperative and post -operative pain.
|
Baseline to 7days
|
Collaborators and Investigators
Investigators
- Principal Investigator: Kajal Bhayani, Post graduate institute of dental sciences, Rohtak
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Kajal Bhayani
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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