Hand and Engine-driven Techniques for Endodontic Retreatment
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|ClinicalTrials.gov Identifier: NCT03743233|
Recruitment Status : Unknown
Verified November 2018 by Maximiliano Sergio Cenci, Federal University of Pelotas.
Recruitment status was: Recruiting
First Posted : November 16, 2018
Last Update Posted : November 16, 2018
|Condition or disease||Intervention/treatment||Phase|
|Pain, Postoperative||Device: Hand file Device: Reciprocating||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Hand and Engine-driven Techniques for Endodontic Retreatment: Randomized Clinical Trial|
|Estimated Study Start Date :||December 1, 2018|
|Estimated Primary Completion Date :||November 1, 2019|
|Estimated Study Completion Date :||March 1, 2020|
|Active Comparator: Hand file instrumentation||
Reciproc R25 file will be used for gutta-percha removal, until reaching the WL. The instrument will be introduced into the canal applying slight movements of 3-mm amplitude. Apical patency will be maintained with a size #15 K-file. The root canals will be reinstrumented using the Reciproc R50 file. For both groups, after the root canal filling removal and reinstrumentation protocol, a new radiograph will be taken, without any intracanal instrument, for posterior analysis of the percentage of remaining filling material in the root canal. If the radiograph demonstrates the persistence of filling material, the technique will be repeated with the last instrument used in the chemomechanical preparation (hand or reciprocating file), also using H-files with circumferential movements against the dentinal walls in order to remove these residual material, followed by abundant irrigation with NaOCl.
|Active Comparator: Reciprocating instrumentation||
Device: Hand file
A crown-down technique will be performed until reaching the provisory WL. The root canals will be initially deobstructed with size #3 and #2 Gates-Glidden burs (Dentsply-Maillefer) at the coronal and middle root thirds. Then, hand stainless steel K-files (Dentsply-Maillefer) with decreasing sizes will be used (#40, #35, #30, #25). The WL will be determined by an electronic apex locator (Novapex; Forum Technologies, Rishon Le-Zion, Israel). A radiograph will be taken to confirm the WL, which should be 1 mm short of the root apex. Apical patency will be reached and maintained with a size #15 K-file (Dentsply-Maillefer). The root canals will be reinstrumented and a size #50 K-file will be standardized as the master apical instrument. A step-back procedure in 1-mm increments followed until merging with the crown-down rotary enlargement (size #70) will be achieved.
- Post operative pain [ Time Frame: 12, 24, 48 hours and 7 days ]Change of post operative pain from baseline to 12h, from 12 to 24h, from 24 to 48h and from 48h to 7 days after treatment, assessed using a visual analog scale, where "zero" means no pain and "10" means maximum pain possible
- Periapical index [ Time Frame: Radiographs will be taken after 3, 6, 12 and 24 months ]the radiograph will be assessed considering the apex of the tooth and changes occurred after 3, 6, 12 and 24months after treatment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03743233
|Federal University of Pelotas||Recruiting|
|Pelotas, RS, Brazil, 96015560|
|Contact: Fernanda G Pappen, PhD 53 984033599 email@example.com|