Mulhern 1982.
Methods | Study design: randomised parallel group, clinical trial. Conducted in USA. Number of centres: not reported. Recruitment period: not reported. Funding source: a Grant‐in‐Aid of research from the Endowment and Memorial Foundation of the American Association of Endodontists. |
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Participants | 60 participants (31 females, 29 males, range age from 13 to 75 years, ethnic group reported: 1 Asian, 42 White and 17 Black). Inclusion criteria: non‐surgical endodontic treatment of asymptomatic mature single‐rooted teeth with necrotic pulps. Exclusion criteria: patients with severe medical conditions, using corticosteroids or anti‐inflammatory drugs and/or recent or active antibiotics therapy. Diagnostic criteria for pulpal or periapical disease: Rx and vitality test. Group 1: randomised 30, analysed 30. Group 2: randomised 30, analysed 30 |
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Interventions | Group 1: single visit. Group 2: multiple visits (3 visits: in the interappointment period no medication was used, only a dry pledget of cotton with a double cement system of Cavit G and zinc oxyphosphate cement in the coronal access cavity was employed). 2 operators (graduate endodontic students). Rubber dam. Use of magnification loupes and canal shaping not detailed. Irrigation: 2.5% sodium hypochlorite. Working length not reported. Obturation with lateral condensation was performed using gutta‐percha and Kerr Tubli‐Seal. |
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Outcomes |
Evaluated at 48 hours after treatment (by a questionnaire) and at 1 week (clinical examination). Participants with multivisit treatment were asked to complete a questionnaire for each visit.
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Notes | Patients in the experimental group received free treatment, whereas those in the control group were charged the usual clinic fee for treatment. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote " The teeth were randomly assigned to group 1 (single visit) or 2 (multiple visits)". |
Allocation concealment (selection bias) | Unclear risk | Not specified. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Comment: not applicable, radiographic assessment was not among outcomes. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 100% of patients who entered the study were included in the final analysis. |
Selective reporting (reporting bias) | Low risk | Planned outcomes reported. |
Other bias | Low risk | Comment: no other source of bias identified. |