Single And Multiple-visit Endodontic Retreatment Outcome.

Outcome Following Single-visit And Multiple-visit Nonsurgical Endodontic Retreatment

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

Study Overview

• Status: Unknown
• Conditions: Apical Periodontitis
• Intervention / Treatment: Procedure: Non surgical Single visit Retreatment; Procedure: Multi visit Retreatment with calcium hydroxide dressing

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: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • 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: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: single visit retreatment; nonsurgical root canal retreatment will be carried out in single visit.	Procedure: Non surgical Single visit Retreatment; 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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline to 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain assessment	Visual analogue scale (VAS) from 0 to 10 will be used to record preoperative and post -operative pain.	Baseline to 7days

Collaborators and Investigators

• Sponsor: Postgraduate Institute of Dental Sciences Rohtak
• Investigators: Principal Investigator: Kajal Bhayani, Post graduate institute of dental sciences, Rohtak

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 15, 2019
• Primary Completion (ANTICIPATED): June 15, 2020
• Study Completion (ANTICIPATED): June 15, 2021

Study Registration Dates

• First Submitted: May 13, 2020
• First Submitted That Met QC Criteria: May 14, 2020
• First Posted (ACTUAL): May 18, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 18, 2020
• Last Update Submitted That Met QC Criteria: May 14, 2020
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Outcome; Nonsurgical Retreatment, Single Visit; Multi visit, Calcium Hydroxide
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Jaw Diseases; Periapical Diseases; Periodontitis; Periapical Periodontitis; Physiological Effects of Drugs; Calcium-Regulating Hormones and Agents; Calcium
• Other Study ID Numbers: Kajal Bhayani

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No