Effect of Resin, Calcium Silicate and Silicone Based Root Canal Sealers on Postoperative Pain
Primary Purpose
Postoperative Pain
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Root Canal Sealants
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain focused on measuring root canal, root canal sealer, postoperative pain
Eligibility Criteria
Inclusion Criteria:
- Healthy persons between the ages of 18 and 45 years
- Mandibular molar teeth that were diagnosed with symptomatic irreversible pulpitis
Exclusion Criteria:
- Patients who are taken analgesic inflammatory drugs with in the last 12 hours
- Pregnancy or lactation
- Teeth with calcified canals
- Teeth with periodontal diseases
- Teeth with sensitive to percussion and palpation
- Teeth with root resorption
- Teeth with immature/open apex
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Ah Plus
I Root SP
GuttaFlow Bioseal
Arm Description
All samples will be filled with Ah Plus root canal sealer and gutta percha
All samples will be filled with I Root SP root canal sealer and gutta percha
All samples will be filled with GuttaFlow Bioseal canal sealer and gutta percha
Outcomes
Primary Outcome Measures
VAS Scala
PP will be assessed with a VAS after endodontic treatment. The VAS consisted of a 100-mm hor- izontal ruler with marks every 10 mm and no numbers except a 0 at the first part of the scale and a 10 in the last part of the scale.
Secondary Outcome Measures
Full Information
NCT ID
NCT05033093
First Posted
August 26, 2021
Last Updated
August 26, 2021
Sponsor
Yuzuncu Yıl University
1. Study Identification
Unique Protocol Identification Number
NCT05033093
Brief Title
Effect of Resin, Calcium Silicate and Silicone Based Root Canal Sealers on Postoperative Pain
Official Title
Effect of Resin, Calcium Silicate and Silicone Based Root Canal Sealers on Postoperative Pain: A Randomized Controlled Clinical Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2021 (Anticipated)
Primary Completion Date
November 1, 2021 (Anticipated)
Study Completion Date
December 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yuzuncu Yıl University
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
After endodontic procedures, depending on the individual and many variables, postoperative pain can be occur within hours and continue for days following the treatment. It is thought that acute inflammation that develops due to chemical, mechanical or microbial injuries in the periapical tissue after endodontic treatment causes postoperative pain. Materials used for root canal obturation can reach periodontal tissues through the apical foramen, lateral canals or leakage and may affect the healing process in the periodontium. For this reason, knowing the properties of root canal obturation materials is important in terms of preventing postoperative pain.
Calcium silicate-based root canal sealer are recommended to be used as they enhance healing after endodontic treatment by promoting differentiation of odontoblasts and the release of bioactive compounds. At the same time, it has been reported that it has less cytotoxic effect compared to the resin-based AH Plus, which is widely used for root canal). Silicone-based root canal sealers have good biological properties on human ligament periodontal fibroblasts. It has been reported that GuttaFlow Bioseal root canal sealer, which has been used in recent years, has less cytotoxic effect than GuttaFlow2, MTA Fillapex and AH Plus sealers. Ateş et al.(2019) evaluated that the effects of different root canal sealers on postoperative pain and reported that the use of iRoot SP or AH Plus did not significantly affect pain levels, but iRoot SP sealer required less analgesic intake than AH Plus sealer. Aslan et al. (2020) concluded in their study that calcium silicate and resin-based root canal sealers are similar in terms of postoperative pain and need for analgesic intake. Ferreira et al.(2020) compared the effects of AH Plus, Endofill and MTA Fillapex root canal sealers on postoperative pain and stated that all three root canal sealers cause similar pain levels.
When reviewing the studies on postoperative pain, it is seen that mostly resin and calcium silicate based root canal sealers are evaluated. Studies on calcium silicate and silicone-based root canal sealers seem to focus more on cytotoxicity. However, no study has been found in the literature on the effect of GuttaFlow Bioseal sealer on postoperative pain, which has been popularity in recent years and has low cytotoxicity. Acoording to this information, it is planned to conduct the research described below, on the effect of calcium silicate-based (iRoot SP), silicone-based (GuttaFlow Bioseal) and rezin-based (AH Plus) sealer on postoperative pain.
Detailed Description
The study is planned to be carried out on 84 patients who were diagnosed and followed up in Van Yüzüncü Yıl University, Faculty of Dentistry, Department of Endodontics, aged between 18-50 years, without any systemic disease. Patients diagnosed with irreversible pulpitis will be included in the study group. Patients with periapical lesions and open apex teeth will not be included in the study group. Before the treatment, pain levels of patients will be record according to the VAS scale.
Dental anesthesia will be achieved using local anesthetic solution (Maxicaine DS fort, Vem, Istanbul, Turkey) for inferior alveolar nerve blockade. After rubber dam isolation, endodontic access cavity will be prepared using high-speed burs. The working length will be determined with using apex locator (Propex Pixi, Dentsply Maillefer) and periapical radiographs with placing a #15 K-file (VDW GmbH, Munich, Germany) into the root canals at the end of the apical narrowing. The root canals will be mechanically prepared using ProTaperNext (DentsplyMaillefer,Baillagues,Switzerland) up to the X3 numbered instrument as standard in each patient. During instrumentation, irrigation will be performed with 2 mL 5.25% NaOCl (Microvem AF, İstanbul, Türkey) at each file change. A dental injector and a 27 gauge dental needle tip will be used for irrigation. The tip of the cannulas will be adjusted to reach two-thirds of the working size. According to the final irrigation procedure, all canals will be irrigated with 5 mL of 17% EDTA solution (Imicryl, Konya, Turkey), 5 mL of 5.25% NaOCI solution and 5 mL of saline, respectively.
After the final irrigation process root canals will be dried with sterile paper points and then randomly divided into three main groups according to the root canal sealer (G1: AH Plus; G2: iRoot SP; G3: GuttaFlow Bioseal) to be used in the obturation process (n: 28). All groups will be filled with sterile gutta-percha and root canal sealers in the same session using the single-cone technique. Teeth with completed root canal treatment will be restored with coronal sealing. After the treatment, patients in all three groups will be asked to report their pain levels according to the VAS scale at certain intervals (6th hour - 24th hour - 48. hour - 72. hour - 1st week) and their need of analgesic use. According to the questionnaires collected with patient feedback, pain levels will be evaluated after root canal treatment completed in a single session.
Descriptive statistics in terms of the features emphasized; It will be expressed as Average, Standard Deviation, Minimum and Maximum value. In order to compare the groups and Times (6, 24, 48, 72nd Hour and 1st Week) in terms of these characteristics, directional analysis of variance with two factors and one factor repeated, will be used. Duncan test will be used to identify different groups following analysis of variance. In determining the relationship between these variables, Pearson correlation coefficients will be calculated separately for the groups. Statistical significance level will be taken as 5% in calculations and SPSS statistical package program will be used for calculations.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
root canal, root canal sealer, postoperative pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
After the final irrigation process root canals will be dried with sterile paper points and then randomly divided into three main groups according to the root canal sealer ; G1: AH Plus G2: iRoot SP G3: GuttaFlow Bioseal to be used in the obturation process (n: 28).
Masking
Participant
Allocation
Randomized
Enrollment
84 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ah Plus
Arm Type
Active Comparator
Arm Description
All samples will be filled with Ah Plus root canal sealer and gutta percha
Arm Title
I Root SP
Arm Type
Active Comparator
Arm Description
All samples will be filled with I Root SP root canal sealer and gutta percha
Arm Title
GuttaFlow Bioseal
Arm Type
Active Comparator
Arm Description
All samples will be filled with GuttaFlow Bioseal canal sealer and gutta percha
Intervention Type
Drug
Intervention Name(s)
Root Canal Sealants
Intervention Description
it is planned to conduct the research described below, on the effect of calcium silicate-based (iRoot SP), silicone-based (GuttaFlow Bioseal) and rezin-based (AH Plus) sealer on postoperative pain
Primary Outcome Measure Information:
Title
VAS Scala
Description
PP will be assessed with a VAS after endodontic treatment. The VAS consisted of a 100-mm hor- izontal ruler with marks every 10 mm and no numbers except a 0 at the first part of the scale and a 10 in the last part of the scale.
Time Frame
up to 7 days
10. Eligibility
Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy persons between the ages of 18 and 45 years
Mandibular molar teeth that were diagnosed with symptomatic irreversible pulpitis
Exclusion Criteria:
Patients who are taken analgesic inflammatory drugs with in the last 12 hours
Pregnancy or lactation
Teeth with calcified canals
Teeth with periodontal diseases
Teeth with sensitive to percussion and palpation
Teeth with root resorption
Teeth with immature/open apex
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hacer Şahin Aydınyurt, PhdD
Phone
905304589710
Email
hacersahin@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Murat Tunca, PhD
Phone
90530458910
Email
dtmurattunca@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
After the final irrigation process root canals will be dried with sterile paper points and then randomly divided into three main groups according to the root canal sealer (G1: AH Plus; G2: iRoot SP; G3: GuttaFlow Bioseal) to be used in the obturation process (n: 28). All groups will be filled with sterile gutta-percha and root canal sealers in the same session using the single-cone technique. Teeth with completed root canal treatment will be restored with coronal sealing. After the treatment, patients in all three groups will be asked to report their pain levels according to the VAS scale at certain intervals (6th hour - 24th hour - 48. hour - 72. hour - 1st week) and their need of analgesic use. According to the questionnaires collected with patient feedback, pain levels will be evaluated after root canal treatment completed in a single session.
Citations:
PubMed Identifier
29571915
Citation
Graunaite I, Skucaite N, Lodiene G, Agentiene I, Machiulskiene V. Effect of Resin-based and Bioceramic Root Canal Sealers on Postoperative Pain: A Split-mouth Randomized Controlled Trial. J Endod. 2018 May;44(5):689-693. doi: 10.1016/j.joen.2018.02.010. Epub 2018 Mar 20.
Results Reference
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Effect of Resin, Calcium Silicate and Silicone Based Root Canal Sealers on Postoperative Pain
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