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The purpose of this study was to evaluate the clinical and radiological outcomes of iRoot SP as a root canal sealer in comparison with AH Plus sealer within 1-year follow up.Patients needing root canal treatment were enrolled and allotted into either iRoot SP group or AH Plus arm randomly. After root canal shaping and cleaning, the teeth were obturated according to their arms. Assessment of postoperative pain was done 1 week after root canal obturation using visual analog scale. After 1-year follow-up, clinical and radiographic evaluations were carried out. Statistical analysis at P < 0.05 was conducted to measure difference between the arms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| iRoot SP sealer | Experimental | iRoot SP sealer was used as root canal sealer in root canal obturation. |
|
| AH Plus sealer | Active Comparator | AH Plus sealer was used as a gold standard to be compared with iRoot SP sealer in root canal obturation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Root canal sealer | Procedure | Patients who required root canal therapy were enrolled and allotted into either iRoot SP arm or AH Plus arm randomly.For Test Arm: iRoot SP was used as a sealer. Obturation was performed with Gutta-percha cones and root canal sealer by continuous-wave condensation technique. For Control Arm: AH Plus was used as root canal sealer. The same steps were followed for obturation as in Test Arm. |
| Measure | Description | Time Frame |
|---|---|---|
| Radiographical assessments | The periapical status was assessed in the radiographs.Teeth with complete restitution of the periodontal contours were judged as "healed". Teeth with a clearly decreased size of the periapical radiolucency were judged as "healing". Teeth with unchanged, increased, or new periapical radiolucency were judged as "failed". | 1 year after root canal therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical assessments | The root filled tooth was considered clinically successful if there was absence of clinical sign or symptom such as spontaneous pain, sensitivity to percussion or palpation, abnormal mobility, signs of pathology like abscess or sinus tract. | 1 year after root canal therapy |
| Postoperative Pain Evaluation |
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Inclusion Criteria:
Subjects were required to:
Exclusion Criteria:
Subjects with:
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| Name | Affiliation | Role |
|---|---|---|
| Hui Chen | Affiliated Hospital of Stomatology, College of Medicine, Zhejiang University | Study Chair |
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| ID | Term |
|---|---|
| D010485 | Periapical Periodontitis |
| ID | Term |
|---|---|
| D010483 | Periapical Diseases |
| D007571 | Jaw Diseases |
| D009057 | Stomatognathic Diseases |
| D010510 | Periodontal Diseases |
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|
Pain was evaluated by using a visual analogue scale (VAS) made of a 10 cm line, where 0 = no pain and 10 = unbearable pain. |
| 1 week after root canal therapy |
| D009059 |
| Mouth Diseases |
| D010518 | Periodontitis |