Clinical trial NCT03918733: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Root Canal Therapy
Periapical Periodontitis
Keywords: retreatment
endodontic surgery
nonsurgical endodontic retreatment
Lead sponsor: Postgraduate Institute of Dental Sciences Rohtak
Sponsor class: OTHER
First posted: 2019-04-17
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Radiographic success
timeFrame: Baseline to one year
Secondary outcomes:
Other outcomes:
Locations:
city: Rohtak
country: India
facility: Post graduate institute of dental sciences
state: Haryana
Study officials:
References: