Single And Multiple-visit Endodontic Retreatment Outcome.

NCT04390789 | Unknown

• 1 other identifier: Kajal Bhayani
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Apical Periodontitis

Keywords

Nonsurgical Retreatment, Single Visit; Multi visit, Calcium Hydroxide; Outcome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Pain assessment

  Baseline to 7days

Study Arms (2)

single visit retreatment

EXPERIMENTAL

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

Procedure: Non surgical Single visit Retreatment

multi visit retreatment

ACTIVE COMPARATOR

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

Interventions

Non surgical Single visit Retreatment PROCEDURE

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

single visit retreatment

Multi visit Retreatment with calcium hydroxide dressing 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

multi visit retreatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

Study Sites (2)

Post graduate institute of dental sciences

Rohtak, Haryana, 124001, India

RECRUITING

Sanjay Tewari

Rohtak, Haryana, 124001, India

RECRUITING

MeSH Terms

Conditions

Periapical Periodontitis

Condition Hierarchy (Ancestors)

Periapical Diseases; Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis

Study Officials

• Kajal Bhayani

  POST GRADUATE INSTITUTE OF DENTAL SCIENCES, ROHTAK

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kajal Bhayani

CONTACT

7507962278; bhayanikajal@gmail.com

DR PANKAJ SANGWAN

CONTACT

9996112202; drps_1@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2020
• First Posted: May 18, 2020
• Study Start: December 15, 2019
• Primary Completion: June 15, 2020
• Study Completion: June 15, 2021
• Last Updated: May 18, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

IN (2)