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

Not Applicable

Completed

• Conditions: Asymptomatic Vital Mandibular Molar Teeth
• Interventions: Other: AH Plus root canal sealer; Other: MTA Fillapex root canal sealer

• Registration Number: NCT05266599
• Lead Sponsor: Ege University

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

Study Timeline

• Study Start: 2019-11-20
• Primary Completion: 2022-02-07
• Study Completion: 2022-02-07
• Study First Submitted: 2022-02-19
• Status Verified: 2022-03
• Study First Submitted QC: 2022-03-03
• Last Update Submitted: 2022-03-03
• Study First Posted: 2022-03-04
• Last Update Posted: 2022-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AH Plus group	AH Plus root canal sealer	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.
MTA Fillapex group	MTA Fillapex root canal sealer	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.

Primary Outcome Measures

Name	Time	Method
The incidence and intensity of post-obturation pain	up to 30-day	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

Name	Time	Method
Clinical and radiographical success with resin-based and MTA-based bioceramic sealer	1 year and 2 year follow-up	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".

Trial Locations

Locations (1)

Gözde Kandemir Demirci; 🇹🇷 İzmir, Turkey