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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

NCT05266599 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2022-03-04

No results posted yet for this study

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.

Conditions

  • Asymptomatic Vital Mandibular Molar Teeth

Interventions

OTHER

MTA Fillapex root canal sealer

Root canal treatments were performed with MTA Fillapex

OTHER

AH Plus root canal sealer

Root canal treatments were performed with AH plus

Sponsors & Collaborators

  • Ege University

    lead OTHER

Principal Investigators

  • Gözde K Demirci, Dr · Ege University Faculty of Dentistry

  • Melis Coşar · Ege University Faculty of Dentistry

  • Mehmet Kemal Çalışkan, Prof.Dr · Ege University Faculty of Dentistry

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-11-20
Primary Completion
2022-02-07
Completion
2022-02-07

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05266599 on ClinicalTrials.gov