Clinical trial NCT05266599: 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
Overall status: COMPLETED
Phase: NA
Conditions: Asymptomatic Vital Mandibular Molar Teeth
Keywords: asymptomatic irreversible pulpitis
bioceramic sealer
post-obturation pain
resin-based sealer
treatment outcome
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2022-03-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: The incidence and intensity of post-obturation pain
timeFrame: up to 30-day
Secondary outcomes:
measure: Clinical and radiographical success with resin-based and MTA-based bioceramic sealer
timeFrame: 1 year and 2 year follow-up
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Gözde Kandemir Demirci
Study officials:
affiliation: Ege University Faculty of Dentistry
name: Gözde K Demirci, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Ege University Faculty of Dentistry
name: Melis Coşar
role: STUDY_CHAIR
affiliation: Ege University Faculty of Dentistry
name: Mehmet Kemal Çalışkan, Prof.Dr
role: STUDY_CHAIR
References:
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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.