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

NCT ID: NCT03918733

Last Updated: 2019-04-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2019-05-01

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.

Detailed Description

TITLE: Comparative evaluation of clinical and radiographic outcome of nonsurgical retreatment and endodontic surgery of root filled teeth.

RATIONALE: 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.

AIM AND OBJECTIVES: Evaluate and compare the clinical and radiographic outcomes of nonsurgical endodontic retreatment and endodontic surgery.

SETTING: Study subjects should be recruited from the Post Graduate Department of Conservative Dentistry and Endodontics, PGIDS, Rohtak, Haryana.

STUDY DESIGN: Prospective randomized study

Method: Patients with above inclusion criteria will be selected and randomly allocated to one of the two study groups ( nonsurgical retreatment , endodontic microsurgery ). Root canal retreatment will be performed according to standard protocol. Surgical procedures will be carried out under operating microscope with 8 × 16 magnification by following standardized treatment methods.

Outcome measures: Follow up will be done every 3 months till 12 month period to assess clinical and radiographic success of nonsurgical retreatment and endodontic microsurgery. Clinical success will be assessed by 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. Radiographic success will be assessed by the criteria followed by Rud et al. (1972) and Molven et al. (1987). Intensity of pain will be assessed using Visual Analog Scale. Pain intensity will be recorded at different intervals (preoperatively, after 6 hours, 12 hours, 18 hours, 1day, 2 days, 3 days, 4 days, 5 days, 6 days and 7 days). Intake of analgesic will also be recorded.

Statistical Analysis: The data gathered will be analyzed using suitable statistical methods.

Conditions

Root Canal Therapy; Periapical Periodontitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

surgical treatment

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

Group Type: EXPERIMENTAL

surgical treatment

Intervention Type: PROCEDURE

surgical treatment will be done of failed root canal treated teeth

Non surgical retreatment

Non surgical retreatment of failed root canal treated teeth

Group Type: EXPERIMENTAL

Non surgical retreatment

Intervention Type: PROCEDURE

Non surgical retreatment will be done.

Interventions

surgical treatment

surgical treatment will be done of failed root canal treated teeth

Intervention Type: PROCEDURE

Non surgical retreatment

Non surgical retreatment will be done.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• • 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Postgraduate Institute of Dental Sciences Rohtak

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Post graduate institute of dental sciences

Rohtak, Haryana, India

Countries

India

Other Identifiers

usha yadav

Identifier Type: -

Identifier Source: org_study_id