Hand & Engine-driven Techniques for Endodontic Retreatment

Status Recruiting

Clinical Trial Summary

Numerous instrumentation techniques have been suggested for the nonsurgical retreatment of teeth with primary failure of endodontic therapy in laboratory studies. However, there is limited clinical evidence about those different techniques. The objective of this study is to compare the prevalence and intensity of postoperative pain, as well as the success rate after endodontic retreatment with hand or engine-driven reciprocating instrumentation. A randomized clinical trial will be performed, considering two comparison groups: hand preparation with stainless steel instruments or engine-driven reciprocating preparation with the Reciproc NiTi System (VDW, Munich, Germany), to verify which technique would lead to lower postoperative pain levels and higher endodontic success rates. Secondary outcomes related to technique efficiency will be also registered, evaluating the capacity of filling material removal and the time spent on the clinical procedures. Eighty individuals who need endodontic retreatment in single-rooted teeth will be selected (n=40/group). Endodontic reintervention will be carried out in two visits. Periapical radiographs taken after root filling removal protocols will be transferred to an image analysis software. Then, the percentage of remaining filling material in relation to the total area of the root canal will be evaluated. The clinical time spent with the removal procedure protocol will be registered, in minutes, by a digital stopwatch. After each visit, postoperative pain will be assessed using a numerical rating scale. The record of pain and analgesic drug intake will be performed in 12, 24, 48 hours and 7 days after the clinical procedures. Success rates will be evaluated after 3, 6, 12 and 24 months, through clinical and radiographic examination, considering the Periapical Index, a 5-point score system. Data of both groups (percentage of remaining debris, operating time, postoperative pain, clinical and radiographic success) will be analyzed for normality by the Shapiro-Wilk test. Assuming normal distribution, the data will be compared by t test. Pearson's correlation coefficient will be applied to detect possible correlations between the evaluated outcomes. Differences will be considered significant at P=0.05.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Pain, Postoperative

Clinical Trial Details

NCT number	NCT03743233
Study type	Interventional
Source	Federal University of Pelotas
Contact
Status	Recruiting
Phase	N/A
Start date	December 1, 2018
Completion date	March 1, 2020

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Hand and Engine-driven Techniques for Endodontic Retreatment

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms