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| ID | Type | Description | Link |
|---|---|---|---|
| TS-GAP-2024-32255 | Other Grant/Funding Number | Ege University Scientific Research Projects |
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Sixty-three mandibular molars with vital pulp, symptomatic acute pain, and a Numerical Rating Scale (NRS) score of 7 or higher-requiring emergency treatment-were randomly allocated into three groups according to the preparation systems to be used: conventional manual instrumentation technique with hand files, reciprocating motion technique with WaveOne Gold files, and rotary motion technique with ProTaper Ultimate files.
In the first session, patients received emergency treatment with one of the three file systems, and seven days later, root canal treatments were completed using the same system within each patient group. Preoperative pain scores of patients presenting to our clinic with acute pain were recorded using the Numerical Rating Scale (NRS).
During the emergency root canal treatment session, the first group was instrumented with hand files, the second group with WaveOne Gold files, and the third group with ProTaper Ultimate files, and the emergency treatment session was completed. Shaping times were measured during the procedures.
Following the emergency session, patients were instructed to record their postoperative pain at the 6th hour, 12th hour, and on the 1st, 2nd, 3rd, 4th, 5th, 6th, and 7th days using the provided NRS.
One week after the emergency treatment session, root canal obturation was performed using each system's own gutta-percha and Bioceramic root canal sealer. Clinical and radiographic follow-ups were carried out at 6 and 12 months.
• This randomized clinical study was conducted to evaluate and compare the effects of the conventional step-back technique with hand files, the reciprocal technique with WaveOne Gold files, and the rotary technique with ProTaper Ultimate files on the frequency and intensity of pain before and after emergency treatment, as well as on clinical and radiological outcomes in symptomatic and acutely painful vital molars during root canal treatment.
Sixty-three symptomatic mandibular molars with vital pulp were randomly allocated into three groups according to the preparation system used: Hand files, WaveOne Gold, and ProTaper Ultimate. The file systems assigned to each group were used for root canal preparation in all cases.
In the rotary and reciprocating file groups, obturation was performed with their own gutta-percha using the single cone technique with Bioceramic sealer and in the conventional hand file group root canal obturation was performed with cold lateral compaction method.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional Manuel Instrumentation Technique Group | Active Comparator | Root canals were prepared with hand files. Irrigation was performed with 10 mL of NaOCl, followed by 5 mL of 17% ethylenediaminetetraacetic acid (EDTA). Temporary coronal restoration was completed with glass ionomer cement. For this group, 72 hours after the completion of root canal preparation in the emergency intervention session, calcium hydroxide was applied to the root canals for 7 days, and the teeth were obturated using a bioceramic root canal sealer with the system-specific gutta-percha and obturation methods recommended by the manufacturers. |
|
| Reciprocating Motion Technique Group | Active Comparator | Root canals were prepared with WaveOne Gold instruments and an X-Smart Plus (Dentsply Maillefer, Switzerland) endodontic motor. Irrigation was performed with 10 mL of NaOCl, followed by 5 mL of 17% ethylenediaminetetraacetic acid (EDTA). Temporary coronal restoration was completed with glass ionomer cement. For this group, 72 hours after the completion of root canal preparation in the emergency intervention session, calcium hydroxide was applied to the root canals for 7 days, and the teeth were obturated using a bioceramic root canal sealer with the system-specific gutta-percha and obturation methods recommended by the manufacturers. |
|
| Rotation Motion Technique Group | Active Comparator | Root canals were prepared with ProTaper Ultimate instruments and an X-Smart Plus (Dentsply Maillefer, Switzerland) endodontic motor. Irrigation was performed with 10 mL of NaOCl, followed by 5 mL of 17% ethylenediaminetetraacetic acid (EDTA). Temporary coronal restoration was completed with glass ionomer cement. For this group, 72 hours after the completion of root canal preparation in the emergency intervention session, calcium hydroxide was applied to the root canals for 7 days, and the teeth were obturated using a bioceramic root canal sealer with the system-specific gutta-percha and obturation methods recommended by the manufacturers. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Root canal preparation with Hand Files (Dentsply Sirona) | Device | Root canal treatments were performed with hand files |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to 30-day |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical and radiographical success | Clinical success was determined by the absence of any clinical or radiographic indicators of inflammation or infection, and outcomes were categorized as either successful or unsuccessful.Unsuccessful ones were scored as "0" and successful ones as "1". During the clinical examination, the presence of swelling, pain, sinus tract formation, or tenderness upon percussion or palpation was documented. Periodontal probing depths were assessed for each case. Radiographic analysis evaluated the integrity of periodontal tissues and the presence or absence of periapical radiolucent areas. The level of root canal fillings was classified as short (≥2 mm from the apex), acceptable (0-2 mm), or overfilled (beyond apex). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gözde Kandemir Demirci, Associate Professor | Ege University Faculty of Dentistry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gözde Kandemir Demirci | Izmir | 35100 | Turkey (Türkiye) |
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| Root canal preparation with the WaveOne Gold file system (Dentsply Sirona, Ballaigues, Switzerland) | Device | Root canal treatments were performed with WaveOne Gold Files |
|
| Root canal preparation with the ProTaper Ultimate file system (Dentsply Sirona) | Device | Root canal treatments were performed with ProTaper Ultimate Files |
|
| Up to 1 year follow up |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D018915 | Root Canal Preparation |
| ID | Term |
|---|---|
| D012390 | Root Canal Therapy |
| D004708 | Endodontics |
| D003813 | Dentistry |
| D019246 | Tooth Preparation |
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