Clinical trial NCT03743233: Hand and Engine-driven Techniques for Endodontic Retreatment
Official title: Hand and Engine-driven Techniques for Endodontic Retreatment: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain, Postoperative
Lead sponsor: Federal University of Pelotas
Sponsor class: OTHER
First posted: 2018-11-16
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Good systemic and oral health;
* Requiring root canal retreatment in single-rooted teeth (one root and one root canal);
* Asymptomatic persistent apical periodontitis.

Exclusion Criteria:

* Use of analgesics, anti-inflammatory drugs or other pain modulating drugs;
* Chronic systemic disease (eg: diabetes, hypertension, arthritis and renal dysfunction);
* Systemic disease that could interfere with bone quality;
* Pregnant or breastfeeding women;
* Teeth with untreated periodontal disease;
* Abnormal mobility and with excessively large or curved canals.

Primary outcomes:
measure: Post operative pain
timeFrame: 12, 24, 48 hours and 7 days
Secondary outcomes:
measure: Periapical index
timeFrame: Radiographs will be taken after 3, 6, 12 and 24 months
Other outcomes:
Locations:
city: Pelotas
country: Brazil
facility: Federal University of Pelotas
state: RS
Study officials:
References: