Comparision of Non Surgical Retreatment and Endodontic Surgery of Failed Root Canal Treated Teeth

NCT03918733 | Unknown DMC

• 1 other identifier: usha yadav
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

To the best of our knowledge, only two studies are available which have provided a direct comparison between outcome of nonsurgical retreatment and endodontic surgery. The results of the two studies are contradictory in nature. Two systematic reviews conducted to explore the issue also could not draw any definitive conclusions and suggested that further research is necessary to find out effects of surgical versus nonsurgical approach. Considering the very limited amount of data on this pertinent topic, there is apparent need of high quality randomized controlled studies to further investigate the difference in outcome between nonsurgical retreatment and endodontic surgery.

Conditions

Root Canal Therapy; Periapical Periodontitis

Keywords

retreatment; endodontic surgery; nonsurgical endodontic retreatment

Outcome Measures

Primary Outcomes (1)

• Radiographic success

  Follow up will be done every 3 months till 12 months. scoring of each tooth will be done according to criteria followed by Rud et al (1972) and Molven et al (1987) 1. Complete healing, defined by re-establishment of the lamina dura 2. Incomplete healing (scar tissue) 3. Uncertain healing 4. Unsatisfactory healing (failure)

  Baseline to one year

Study Arms (2)

surgical treatment

EXPERIMENTAL

surgical treatment of failed root canal treated teeth following secondary root canal treatment.

Procedure: surgical treatment

Non surgical retreatment

EXPERIMENTAL

Non surgical retreatment of failed root canal treated teeth

Procedure: Non surgical retreatment

Interventions

surgical treatment PROCEDURE

surgical treatment will be done of failed root canal treated teeth

surgical treatment

Non surgical retreatment PROCEDURE

Non surgical retreatment will be done.

Non surgical retreatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• 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 treatment.
• Radiographic evidence of periapical radiolucency (minimum size ≥ 2.0 × 2.0 mm2).
• Failure of previous root canal treatment will be determined based on clinical and radiographic examinations.
• Patient's age more than 18 years.

You may not qualify if:

• Positive history of antibiotic use within past three months of the treatment.
• Positive history of analgesic use within the past 7 days.
• Procedural errors in previous root canal treatment which are not manageable.
• Patients who are pregnant, diabetic, having human immunodeficiency virus infection or other immunocompromising conditions, had serious medical illness or requiring antibiotic premedication.
• Patients with unrestorable lesions, fractures involving the periodontium, and/or periodontal pockets ≥ 4mm deep or having marginal or furcal bone loss due to periodontitis.

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

Study Sites (1)

Post graduate institute of dental sciences

Rohtak, Haryana, 124001, India

Location

MeSH Terms

Conditions

Periapical Periodontitis

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2019
• First Posted: April 17, 2019
• Study Start: January 1, 2018
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: April 17, 2019

Record last verified: 2019-04

Locations

IN (1)