Comparision of Non Surgical Retreatment and Endodontic Surgery of Failed Root Canal Treated Teeth
Primary Purpose
Root Canal Therapy, Periapical Periodontitis
Status
Unknown status
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
surgical treatment
Non surgical retreatment
Sponsored by
About this trial
This is an interventional treatment trial for Root Canal Therapy focused on measuring retreatment, endodontic surgery, nonsurgical endodontic retreatment
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.
Sites / Locations
- Post graduate institute of dental sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
surgical treatment
Non surgical retreatment
Arm Description
surgical treatment of failed root canal treated teeth following secondary root canal treatment.
Non surgical retreatment of failed root canal treated teeth
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Full Information
NCT ID
NCT03918733
First Posted
April 15, 2019
Last Updated
April 15, 2019
Sponsor
Postgraduate Institute of Dental Sciences Rohtak
1. Study Identification
Unique Protocol Identification Number
NCT03918733
Brief Title
Comparision of Non Surgical Retreatment and Endodontic Surgery of Failed Root Canal Treated Teeth
Official Title
Comparative Evaluation of Clinical and Radiographic Outcome of Nonsurgical Retreatment and Endodontic Surgery of Root Filled Teeth"
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
May 1, 2019 (Anticipated)
Study Completion Date
May 1, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Postgraduate Institute of Dental Sciences Rohtak
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Root Canal Therapy, Periapical Periodontitis
Keywords
retreatment, endodontic surgery, nonsurgical endodontic retreatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
86 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
surgical treatment
Arm Type
Experimental
Arm Description
surgical treatment of failed root canal treated teeth following secondary root canal treatment.
Arm Title
Non surgical retreatment
Arm Type
Experimental
Arm Description
Non surgical retreatment of failed root canal treated teeth
Intervention Type
Procedure
Intervention Name(s)
surgical treatment
Intervention Description
surgical treatment will be done of failed root canal treated teeth
Intervention Type
Procedure
Intervention Name(s)
Non surgical retreatment
Intervention Description
Non surgical retreatment will be done.
Primary Outcome Measure Information:
Title
Radiographic success
Description
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)
Time Frame
Baseline to one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Post graduate institute of dental sciences
City
Rohtak
State/Province
Haryana
ZIP/Postal Code
124001
Country
India
12. IPD Sharing Statement
Learn more about this trial
Comparision of Non Surgical Retreatment and Endodontic Surgery of Failed Root Canal Treated Teeth
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