Hand and Engine-driven Techniques for Endodontic Retreatment
Primary Purpose
Pain, Postoperative
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Hand file
Reciprocating
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Postoperative
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.
Sites / Locations
- Federal University of PelotasRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Hand file instrumentation
Reciprocating instrumentation
Arm Description
Outcomes
Primary Outcome Measures
Post operative pain
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
Secondary Outcome Measures
Periapical index
the radiograph will be assessed considering the apex of the tooth and changes occurred after 3, 6, 12 and 24months after treatment
Full Information
NCT ID
NCT03743233
First Posted
October 16, 2018
Last Updated
November 14, 2018
Sponsor
Federal University of Pelotas
1. Study Identification
Unique Protocol Identification Number
NCT03743233
Brief Title
Hand and Engine-driven Techniques for Endodontic Retreatment
Official Title
Hand and Engine-driven Techniques for Endodontic Retreatment: Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2018 (Anticipated)
Primary Completion Date
November 1, 2019 (Anticipated)
Study Completion Date
March 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Pelotas
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hand file instrumentation
Arm Type
Active Comparator
Arm Title
Reciprocating instrumentation
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Hand file
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Reciprocating
Intervention Description
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.
Primary Outcome Measure Information:
Title
Post operative pain
Description
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
Time Frame
12, 24, 48 hours and 7 days
Secondary Outcome Measure Information:
Title
Periapical index
Description
the radiograph will be assessed considering the apex of the tooth and changes occurred after 3, 6, 12 and 24months after treatment
Time Frame
Radiographs will be taken after 3, 6, 12 and 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Federal University of Pelotas
City
Pelotas
State/Province
RS
ZIP/Postal Code
96015560
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fernanda G Pappen, PhD
Phone
53 984033599
Email
ferpappen@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Hand and Engine-driven Techniques for Endodontic Retreatment
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