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

Periapical Periodontitis Clinical Trial

Official title: Comparative Evaluation of Clinical and Radiographic Outcome of Nonsurgical Retreatment and Endodontic Surgery of Root Filled Teeth"

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Periapical Periodontitis
• Periodontitis
• Root Canal Therapy

• NCT number: NCT03918733
• Study type: Interventional
• Source: Postgraduate Institute of Dental Sciences Rohtak
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 1, 2018
• Completion date: May 1, 2019