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"

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03918733
• Other study ID #: usha yadav
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: May 1, 2019

Study information

• Verified date: April 2019
• Source: Postgraduate Institute of Dental Sciences Rohtak
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 86
• Est. completion date: May 1, 2019
• Est. primary completion date: May 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Periapical Periodontitis
• Periodontitis
• Root Canal Therapy

Intervention

Procedure:
• surgical treatment
surgical treatment will be done of failed root canal treated teeth
• Non surgical retreatment
Non surgical retreatment will be done.

Locations

Country	Name	City	State
India	Post graduate institute of dental sciences	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	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); Complete healing, defined by re-establishment of the lamina dura; Incomplete healing (scar tissue); Uncertain healing; Unsatisfactory healing (failure)	Baseline to one year