An interventional study of surgical treatment and Non surgical retreatment in Root Canal Therapy and Periapical Periodontitis, sponsored by Postgraduate Institute of Dental Sciences Rohtak. Status unknown at 1 site in India. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-04-17.
Sponsored by Postgraduate Institute of Dental Sciences Rohtak · Not applicable, Interventional, and Treatment
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.
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.
256 studies on the registry are indexed under Periapical Periodontitis; 65 are open to participants now.
This study's planned enrollment of 86 is above the median of 60 across 222 interventional studies indexed under Periapical Periodontitis.
Browse Periapical Periodontitis studies →Postgraduate Institute of Dental Sciences Rohtak is the lead sponsor of 213 studies on the registry; 72 are open to participants now.
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Exclusion Criteria:
surgical treatment of failed root canal treated teeth following secondary root canal treatment.
Procedure: surgical treatment
Non surgical retreatment of failed root canal treated teeth
Procedure: Non surgical retreatment
surgical treatment will be done of failed root canal treated teeth
Non surgical retreatment will be done.
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) 1. Complete healing, defined by re-establishment of the lamina dura 2. Incomplete healing (scar tissue) 3. Uncertain healing 4. Unsatisfactory healing (failure)
Time frame: Baseline to one year
Started Jan 2018 (actual). Primary completion is estimated for May 2019, 16 months after the start.
Of 151 non-industry interventional studies with no phase under Periapical Periodontitis, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 19. This study's planned 16 months is above that.
Counting every sponsor, half of 152 studies reached it within 12 months; a quarter within 6 and three quarters within 19.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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