Single And Multiple-visit Endodontic Retreatment Outcome.

Apical Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04390789
• Other study ID #: Kajal Bhayani
• Status: Recruiting
• Phase: N/A
• Start date: December 15, 2019
• Est. completion date: June 15, 2021

Study information

• Verified date: December 2019
• Source: Postgraduate Institute of Dental Sciences Rohtak
• Contact: Kajal Bhayani
• Phone: 7507962278
• Email: bhayanikajal[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: June 15, 2021
• Est. primary completion date: June 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Apical Periodontitis
• Periapical Periodontitis
• Periodontitis

Intervention

Procedure:
• Non surgical Single visit Retreatment
Non-surgical endodontic retreatment will be carried out in single visit.
• 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

Locations

Country	Name	City	State
India	Post graduate institute of dental sciences	Rohtak	Haryana
India	Sanjay Tewari	Rohtak	Haryana

Sponsors (1)

Lead Sponsor	Collaborator
Postgraduate Institute of Dental Sciences Rohtak

Country where clinical trial is conducted

India, 

Outcome

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