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The Effect of Two Different Root Canal Sealers on Postobturation Pain and Clinical and Radiographical Outcome After Two-year Follow-up

Primary Purpose

Asymptomatic Vital Mandibular Molar Teeth

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
MTA Fillapex root canal sealer
AH Plus root canal sealer
Sponsored by
Ege University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asymptomatic Vital Mandibular Molar Teeth focused on measuring asymptomatic irreversible pulpitis, bioceramic sealer, post-obturation pain, resin-based sealer, treatment outcome

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients older than 18 years
  • Good oral hygiene
  • Patients with mature mandibular first or second molars diagnosed with asymptomatic irreversible pulpitis due to deep caries
  • Teeth that have not been treated endodontically and restoratively before
  • A delayed positive response to cold test and electric pulp tests in the vitality test of the teeth
  • Large pulpal perforation during caries removal
  • Presence of thick and profuse pulpal bleeding could not be controlled within 5 minutes
  • Absence of periapical pathology of teeth when confirmed with periapical radiographically

Exclusion Criteria:

  • Patients who refused to participate in the study
  • The patients are not systemically healthy, allergic to the materials and agents used during root canal treatment
  • Having a history of sensitivity to local anesthetics.
  • Patients who used antibiotics and analgesics in the 7 days prior to the beginning of treatment.
  • Symptomatic or non-vital teeth
  • Patients have more than one tooth requiring endodontic treatment
  • Teeth with material loss that cannot be restored, or teeth that require a post or that will be used as a supporting tooth for a prosthesis
  • The presence of advanced periodontal disease (probing depth >3 mm)
  • Presence of calcified root canal, presence of internal or external root resorption
  • Second molars with C-shaped root canal anatomy

Sites / Locations

  • Gözde Kandemir Demirci

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

MTA Fillapex group

AH Plus group

Arm Description

Root canals were prepared with WaveOne Gold instruments and X-Smart Plus (Dentsply Maillefer, Switzerland) endodontic motor. Final irrigation was performed with 5 ml of 17% ethylene diamine tetraacetic acid (EDTA), 5 ml of 2.5% NaOCl, and distilled water. Then, the root canals were dried with the help of sterilized paper cones. MTA Fillapex sealer was mixed and applied to the root canals and the main gutta-percha cone. Then, the single cone technique was utilized for the obturation of the root canals.

Root canals were prepared with WaveOne Gold instruments and X-Smart Plus (Dentsply Maillefer, Switzerland) endodontic motor. Final irrigation was performed with 5 ml of 17% ethylene diamine tetraacetic acid (EDTA), 5 ml of 2.5% NaOCl, and distilled water. Then, the root canals were dried with the help of sterilized paper cones. AH Plus sealer was mixed and applied to the root canals and the main gutta-percha cone. Then, the single cone technique was utilized for the obturation of the root canals.

Outcomes

Primary Outcome Measures

The incidence and intensity of post-obturation pain
Post-obturation pain up to 30 days after root canal treatment was measured with Numerical Rating Scale. The Numerical Rating Scale is a pain measurement scale that encompasses the following grades: 0 no pain, 1-3 mild pain, 4-6 moderate pain, 7-10 severe pain.

Secondary Outcome Measures

Clinical and radiographical success with resin-based and MTA-based bioceramic sealer
The clinical outcome was determined as success or failure according to objective evaluation of symptoms of inflammation or infection. In clinical examination, swelling, pain, sinus tract, tenderness to percussion and/or palpation test, periodontal probing depths were determined and recorded. The radiographic outcome was evaluated and classified according to the Strindberg criteria (Strindberg 1956). Teeth with a normal contour, width and structure of the periodontal ligament were considered "successful" and teeth with a widened periodontal contours or a new periapical radiolucency were considered "failed". A case was considered unsuccessful when at least one of the clinical and/or radiographic findings was present. Unsuccessful ones were scored as "0" and successful ones as "1".

Full Information

First Posted
February 19, 2022
Last Updated
March 3, 2022
Sponsor
Ege University
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1. Study Identification

Unique Protocol Identification Number
NCT05266599
Brief Title
The Effect of Two Different Root Canal Sealers on Postobturation Pain and Clinical and Radiographical Outcome After Two-year Follow-up
Official Title
The Effect of Two Different Root Canal Sealers on Postobturation Pain in Single-Visit Root Canal Treatment: A Prospective Clinical Randomized Study- Part 1, Influence of Resin-based and Mineral Trioxide Aggregate-based Sealers on Treatment Outcome After Two-year Follow-up in Mandibular Molar Teeth With Asymptomatic Irreversible Pulpitis-Part 2
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
November 20, 2019 (Actual)
Primary Completion Date
February 7, 2022 (Actual)
Study Completion Date
February 7, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ege University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Post-obturation pain evaluation(Part 1): One hundred asymptomatic mandibular molar teeth with vital pulp were randomly assigned into two groups according to the sealer used MTA Fillapex (Angelus Odontologica Industries SA, Londrina, PR, Brazil) or AH Plus (Dentsply Sirona, Ballaigues, Switzerland) sealer. WaveOne Gold instruments were used for root canal preparations in both groups. Root canals were obturated with the manufacturer advised own gutta-percha points of preparation technique and MTA Fillapex was used in the first group and AH Plus was used in the second group as a root canal sealer. Postoperative pain at 6, 12, 24, 48, 72 hours, 4, 5, 6, 7, and 30 days after root canal treatment was measured with the Numerical Rating Scale (NRS), and patients were informed to record the number of analgesics they used during these time periods. Clinical and radiological outcome evaluation(Part 2): Patients were recalled for clinical and radiographic examinations at 12 and 24 months postoperatively. The clinical outcome was determined as success or failure according to objective evaluation of symptoms of inflammation or infection. In clinical examination at follow-up appointments, swelling, pain, sinus tract, tenderness to percussion, and/or palpation test, periodontal probing depths were determined and recorded. The radiographic outcome was evaluated and classified according to the Strindberg criteria. Teeth with a normal contour, width, and structure of the periodontal ligament were considered as"successful" and teeth with a widened periodontal contours or a new periapical radiolucency were considered as "failed". Additionally, the other parameters (age, gender, tooth number, apical gutta level) on treatment success were examined.
Detailed Description
This randomized clinical trial aimed to evaluate and compare the effect of MTA-based bioceramic and resin-based sealers on the incidence and intensity of post-obturation pain and clinical and radiological outcome after two-year follow-up in asymptomatic vital molar teeth in single-visit root canal treatment. One hundred asymptomatic mandibular molar teeth with vital pulp were randomly assigned into two groups according to the sealer used MTA Fillapex (Angelus Odontologica Industries SA, Londrina, PR, Brazil) or AH Plus (Dentsply Sirona, Ballaigues, Switzerland) sealer. WaveOne Gold instruments were used for root canal preparations in both groups. Root canals were obturated with the manufacturer advised own gutta-percha points of preparation technique and MTA Fillapex was used in the first group and AH Plus was used in the second group as a root canal sealer. Post-obturation pain evaluation(Part 1): Postoperative pain at 6, 12, 24, 48, 72 hours, 4, 5, 6, 7, and 30 days after root canal treatment was measured with the Numerical Rating Scale, and patients were informed to record the number of analgesics they used during these time periods. The Mann-Whitney U test was used to compare the postoperative pain and the analgesic use between the two groups according to NRS scores. The relationship between the number of analgesics used and the total NRS values were analyzed by Spearman Correlation Analysis. Evaluation of NRS scores at all time points for each group was done by Friedman Two-Way Analysis of Variance Test. Clinical and radiological outcome evaluation(Part 2): Patients were recalled for clinical and radiographic examinations at 12 and 24 months postoperatively. The clinical outcome was determined as success or failure according to objective evaluation of symptoms of inflammation or infection. In clinical examination at follow-up appointments, swelling, pain, sinus tract, tenderness to percussion, and/or palpation test, periodontal probing depths were determined and recorded. The radiographic outcome was evaluated and classified according to the Strindberg criteria. Teeth with a normal contour, width, and structure of the periodontal ligament were considered as "successful" and teeth with a widened periodontal contours or a new periapical radiolucency were considered as"failed". Additionally, the other parameters (age, gender, tooth number, apical gutta level) on treatment success were examined. All of the pairwise comparisons between the groups at 1st and 2nd year were done by chi-square test (Fisher exact test). Pearson's chi-square test was used to evaluate the age, gender of the patients and tooth types between the groups

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asymptomatic Vital Mandibular Molar Teeth
Keywords
asymptomatic irreversible pulpitis, bioceramic sealer, post-obturation pain, resin-based sealer, treatment outcome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MTA Fillapex group
Arm Type
Active Comparator
Arm Description
Root canals were prepared with WaveOne Gold instruments and X-Smart Plus (Dentsply Maillefer, Switzerland) endodontic motor. Final irrigation was performed with 5 ml of 17% ethylene diamine tetraacetic acid (EDTA), 5 ml of 2.5% NaOCl, and distilled water. Then, the root canals were dried with the help of sterilized paper cones. MTA Fillapex sealer was mixed and applied to the root canals and the main gutta-percha cone. Then, the single cone technique was utilized for the obturation of the root canals.
Arm Title
AH Plus group
Arm Type
Active Comparator
Arm Description
Root canals were prepared with WaveOne Gold instruments and X-Smart Plus (Dentsply Maillefer, Switzerland) endodontic motor. Final irrigation was performed with 5 ml of 17% ethylene diamine tetraacetic acid (EDTA), 5 ml of 2.5% NaOCl, and distilled water. Then, the root canals were dried with the help of sterilized paper cones. AH Plus sealer was mixed and applied to the root canals and the main gutta-percha cone. Then, the single cone technique was utilized for the obturation of the root canals.
Intervention Type
Other
Intervention Name(s)
MTA Fillapex root canal sealer
Intervention Description
Root canal treatments were performed with MTA Fillapex
Intervention Type
Other
Intervention Name(s)
AH Plus root canal sealer
Intervention Description
Root canal treatments were performed with AH plus
Primary Outcome Measure Information:
Title
The incidence and intensity of post-obturation pain
Description
Post-obturation pain up to 30 days after root canal treatment was measured with Numerical Rating Scale. The Numerical Rating Scale is a pain measurement scale that encompasses the following grades: 0 no pain, 1-3 mild pain, 4-6 moderate pain, 7-10 severe pain.
Time Frame
up to 30-day
Secondary Outcome Measure Information:
Title
Clinical and radiographical success with resin-based and MTA-based bioceramic sealer
Description
The clinical outcome was determined as success or failure according to objective evaluation of symptoms of inflammation or infection. In clinical examination, swelling, pain, sinus tract, tenderness to percussion and/or palpation test, periodontal probing depths were determined and recorded. The radiographic outcome was evaluated and classified according to the Strindberg criteria (Strindberg 1956). Teeth with a normal contour, width and structure of the periodontal ligament were considered "successful" and teeth with a widened periodontal contours or a new periapical radiolucency were considered "failed". A case was considered unsuccessful when at least one of the clinical and/or radiographic findings was present. Unsuccessful ones were scored as "0" and successful ones as "1".
Time Frame
1 year and 2 year follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients older than 18 years Good oral hygiene Patients with mature mandibular first or second molars diagnosed with asymptomatic irreversible pulpitis due to deep caries Teeth that have not been treated endodontically and restoratively before A delayed positive response to cold test and electric pulp tests in the vitality test of the teeth Large pulpal perforation during caries removal Presence of thick and profuse pulpal bleeding could not be controlled within 5 minutes Absence of periapical pathology of teeth when confirmed with periapical radiographically Exclusion Criteria: Patients who refused to participate in the study The patients are not systemically healthy, allergic to the materials and agents used during root canal treatment Having a history of sensitivity to local anesthetics. Patients who used antibiotics and analgesics in the 7 days prior to the beginning of treatment. Symptomatic or non-vital teeth Patients have more than one tooth requiring endodontic treatment Teeth with material loss that cannot be restored, or teeth that require a post or that will be used as a supporting tooth for a prosthesis The presence of advanced periodontal disease (probing depth >3 mm) Presence of calcified root canal, presence of internal or external root resorption Second molars with C-shaped root canal anatomy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gözde K Demirci, Dr
Organizational Affiliation
Ege University Faculty of Dentistry
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Melis Coşar
Organizational Affiliation
Ege University Faculty of Dentistry
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mehmet Kemal Çalışkan, Prof.Dr
Organizational Affiliation
Ege University Faculty of Dentistry
Official's Role
Study Chair
Facility Information:
Facility Name
Gözde Kandemir Demirci
City
İzmir
ZIP/Postal Code
35100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32183124
Citation
Zavattini A, Knight A, Foschi F, Mannocci F. Outcome of Root Canal Treatments Using a New Calcium Silicate Root Canal Sealer: A Non-Randomized Clinical Trial. J Clin Med. 2020 Mar 13;9(3):782. doi: 10.3390/jcm9030782.
Results Reference
background
PubMed Identifier
30397735
Citation
Atav Ates A, Dumani A, Yoldas O, Unal I. Post-obturation pain following the use of carrier-based system with AH Plus or iRoot SP sealers: a randomized controlled clinical trial. Clin Oral Investig. 2019 Jul;23(7):3053-3061. doi: 10.1007/s00784-018-2721-6. Epub 2018 Nov 5.
Results Reference
result
PubMed Identifier
32929721
Citation
Aslan T, Donmez Ozkan H. The effect of two calcium silicate-based and one epoxy resin-based root canal sealer on postoperative pain: a randomized controlled trial. Int Endod J. 2021 Feb;54(2):190-197. doi: 10.1111/iej.13411. Epub 2020 Oct 17.
Results Reference
result
PubMed Identifier
31794999
Citation
Fonseca B, Coelho MS, Bueno CEDS, Fontana CE, Martin AS, Rocha DGP. Assessment of Extrusion and Postoperative Pain of a Bioceramic and Resin-Based Root Canal Sealer. Eur J Dent. 2019 Jul;13(3):343-348. doi: 10.1055/s-0039-3399457. Epub 2019 Dec 3.
Results Reference
result
PubMed Identifier
29606401
Citation
Chybowski EA, Glickman GN, Patel Y, Fleury A, Solomon E, He J. Clinical Outcome of Non-Surgical Root Canal Treatment Using a Single-cone Technique with Endosequence Bioceramic Sealer: A Retrospective Analysis. J Endod. 2018 Jun;44(6):941-945. doi: 10.1016/j.joen.2018.02.019. Epub 2018 Mar 29. Erratum In: J Endod. 2018 Jul;44(7):1199.
Results Reference
result
PubMed Identifier
29061359
Citation
Galani M, Tewari S, Sangwan P, Mittal S, Kumar V, Duhan J. Comparative Evaluation of Postoperative Pain and Success Rate after Pulpotomy and Root Canal Treatment in Cariously Exposed Mature Permanent Molars: A Randomized Controlled Trial. J Endod. 2017 Dec;43(12):1953-1962. doi: 10.1016/j.joen.2017.08.007. Epub 2017 Oct 20.
Results Reference
result

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The Effect of Two Different Root Canal Sealers on Postobturation Pain and Clinical and Radiographical Outcome After Two-year Follow-up

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