Table 2.
Y = yes; N = no; PY = probably yes; PN = probably no; NA = not applicable; NI = no information.
| Unique ID | 1 | Study ID | Gururaj et al., 2022 [25] | |
|---|---|---|---|---|
| Aim | adhering to intervention (the ‘per-protocol’ effect) | The effect of adhering to intervention… | failures in implementing the intervention that could have affected the outcome | |
| Source | Journal article(s) | |||
| Outcome | asses the effect of preoperative as well as postoperative photobiomodulation on healing as well pain at mandibular third molar extraction sockets | Weight | 1 | |
| Domain | Signalling question | Response | ||
| Bias arising from the randomization process | 1.1 Was the allocation sequence random? | Y | ||
| 1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions? | PY | |||
| 1.3 Did baseline differences between intervention groups suggest a problem with the randomization process? | PN | |||
| Risk of bias judgement | Low | |||
| Bias due to deviations from intended interventions | 2.1 Were participants aware of their assigned intervention during the trial? | N | ||
| 2.2 Were carers and people delivering the interventions aware of participants’ assigned intervention during the trial? | PN | |||
| 2.3. [If applicable:] If Y/PY/NI to 2.1 or 2.2: Were important non-protocol interventions balanced across intervention groups? | NA | |||
| 2.4. [If applicable:] Were there failures in implementing the intervention that could have affected the outcome? | ||||
| 2.5. [If applicable:] Was there non-adherence to the assigned intervention regimen that could have affected participants’ outcomes? | NA | |||
| 2.6. If N/PN/NI to 2.3, or Y/PY/NI to 2.4 or 2.5: Was an appropriate analysis used to estimate the effect of adhering to the intervention? | NA | |||
| Risk of bias judgement | Low | |||
| Bias due to missing outcome data | 3.1 Were data for this outcome available for all, or nearly all, participants randomized? | Y | ||
| 3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data? | NA | |||
| 3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value? | NA | |||
| 3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value? | NA | |||
| Risk of bias judgement | Low | |||
| Bias in measurement of the outcome | 4.1 Was the method of measuring the outcome inappropriate? | PN | ||
| 4.2 Could measurement or ascertainment of the outcome have differed between intervention groups? | PN | |||
| 4.3 Were outcome assessors aware of the intervention received by study participants? | PN | |||
| 4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received? | NA | |||
| 4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received? | NA | |||
| Risk of bias judgement | Low | |||
| Bias in selection of the reported result | 5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis? | PY | ||
| 5.2 … multiple eligible outcome measurements (e.g., scales, definitions, time points) within the outcome domain? | Y | |||
| 5.3 … multiple eligible analyses of the data? | NI | |||
| Risk of bias judgement | Some concerns | |||
| Overall bias | Risk of bias judgement | Some concerns | ||
| Unique ID | 2 | Study ID | Nejat et al., 2021 [24] | |
| Aim | adhering to intervention (the ‘per-protocol’ effect) | The effect of adhering to intervention… | failures in implementing the intervention that could have affected the outcome | |
| Source | Company-owned trial registry record (e.g., GSK Clinical Study Register record) | |||
| Outcome | effectivness of photobiomodulation therapy for the prevention of incidence of Alveolar osteitis and post-operative pain following third molar surgery | Weight | 1 | |
| Domain | Signalling question | Response | ||
| Bias arising from the randomization process | 1.1 Was the allocation sequence random? | Y | ||
| 1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions? | Y | |||
| 1.3 Did baseline differences between intervention groups suggest a problem with the randomization process? | PN | |||
| Risk of bias judgement | Low | |||
| Bias due to deviations from intended interventions | 2.1 Were participants aware of their assigned intervention during the trial? | N | ||
| 2.2 Were carers and people delivering the interventions aware of participants’ assigned intervention during the trial? | N | |||
| 2.3. [If applicable:] If Y/PY/NI to 2.1 or 2.2: Were important non-protocol interventions balanced across intervention groups? | NA | |||
| 2.4. [If applicable:] Were there failures in implementing the intervention that could have affected the outcome? | PN | |||
| 2.5. [If applicable:] Was there non-adherence to the assigned intervention regimen that could have affected participants’ outcomes? | NA | |||
| 2.6. If N/PN/NI to 2.3, or Y/PY/NI to 2.4 or 2.5: Was an appropriate analysis used to estimate the effect of adhering to the intervention? | NA | |||
| Risk of bias judgement | Low | |||
| Bias due to missing outcome data | 3.1 Were data for this outcome available for all, or nearly all, participants randomized? | Y | ||
| 3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data? | NA | |||
| 3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value? | NA | |||
| 3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value? | NA | |||
| Risk of bias judgement | Low | |||
| Bias in measurement of the outcome | 4.1 Was the method of measuring the outcome inappropriate? | PN | ||
| 4.2 Could measurement or ascertainment of the outcome have differed between intervention groups? | N | |||
| 4.3 Were outcome assessors aware of the intervention received by study participants? | N | |||
| 4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received? | NA | |||
| 4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received? | NA | |||
| Risk of bias judgement | Low | |||
| Bias in selection of the reported result | 5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis? | PN | ||
| 5.2 … multiple eligible outcome measurements (e.g., scales, definitions, time points) within the outcome domain? | Y | |||
| 5.3 … multiple eligible analyses of the data? | NI | |||
| Risk of bias judgement | Some concerns | |||
| Overall bias | Risk of bias judgement | Low | ||
| Unique ID | 3 | Study ID | Pereira 2022 [26] | |
| Aim | adhering to intervention (the ‘per-protocol’ effect) | The effect of adhering to intervention… | failures in implementing the intervention that could have affected the outcome | |
| Source | Journal article(s) | |||
| Outcome | evaluate photobiomodulation therapy with the association of red and infra-red laser therapy in the healing of the post-extraction sockets of third lower molar | Weight | 1 | |
| Domain | Signalling question | Response | ||
| Bias arising from the randomization process | 1.1 Was the allocation sequence random? | Y | ||
| 1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions? | PY | |||
| 1.3 Did baseline differences between intervention groups suggest a problem with the randomization process? | PN | |||
| Risk of bias judgement | Low | |||
| Bias due to deviations from intended interventions | 2.1 Were participants aware of their assigned intervention during the trial? | N | ||
| 2.2 Were carers and people delivering the interventions aware of participants’ assigned intervention during the trial? | N | |||
| 2.3. [If applicable:] If Y/PY/NI to 2.1 or 2.2: Were important non-protocol interventions balanced across intervention groups? | NA | |||
| 2.4. [If applicable:] Were there failures in implementing the intervention that could have affected the outcome? | N | |||
| 2.5. [If applicable:] Was there non-adherence to the assigned intervention regimen that could have affected participants’ outcomes? | NA | |||
| 2.6. If N/PN/NI to 2.3, or Y/PY/NI to 2.4 or 2.5: Was an appropriate analysis used to estimate the effect of adhering to the intervention? | NA | |||
| Risk of bias judgement | Low | |||
| Bias due to missing outcome data | 3.1 Were data for this outcome available for all, or nearly all, participants randomized? | Y | ||
| 3.2 If N/PN/NI to 3.1: Is there evidence that result was not biased by missing outcome data? | NA | |||
| 3.3 If N/PN to 3.2: Could missingness in the outcome depend on its true value? | NA | |||
| 3.4 If Y/PY/NI to 3.3: Is it likely that missingness in the outcome depended on its true value? | NA | |||
| Risk of bias judgement | Low | |||
| Bias in measurement of the outcome | 4.1 Was the method of measuring the outcome inappropriate? | PN | ||
| 4.2 Could measurement or ascertainment of the outcome have differed between intervention groups? | PN | |||
| 4.3 Were outcome assessors aware of the intervention received by study participants? | PN | |||
| 4.4 If Y/PY/NI to 4.3: Could assessment of the outcome have been influenced by knowledge of intervention received? | NA | |||
| 4.5 If Y/PY/NI to 4.4: Is it likely that assessment of the outcome was influenced by knowledge of intervention received? | NA | |||
| Risk of bias judgement | Low | |||
| Bias in selection of the reported result | 5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis? | PY | ||
| 5.2 … multiple eligible outcome measurements (e.g., scales, definitions, time points) within the outcome domain? | PY | |||
| 5.3 … multiple eligible analyses of the data? | NI | |||
| Risk of bias judgement | Some concerns | |||
| Overall bias | Risk of bias judgement | Low | ||