Table 2. Quality Assessment Instrument (QAI) customized from QUADAS (Quality Assessment of Diagnostic Accuracy Studies) tool for assessment of risk of bias for inclusion of studies in the review.
S. No. | Criteria (29) | Response | |
Yes | No | Unclear | |
I. Study design | |||
1. | Objective: objective clearly formulated | ||
2. | Sample size: considered adequate | ||
3. | Spectrum of patients representative of patients receiving the test in practice | ||
4. | Ethical clearance mentioned | ||
5. | Selection criteria: clearly described | ||
6. | Randomization: stated | ||
7. | Baseline characteristics: clearly defined | ||
8. | Control: clearly defined | ||
9. | Orthodontic mechanics explained in sufficient detail to permit replication of experiment | ||
10. | Orthodontic force: clearly specified | ||
11. | Description of execution of index test: sufficient to permit replication of test | ||
12 | Absence of time difference between index test & control: mentioned | ||
13. | Index test executed at specified time and environmental conditions | ||
14. | Use of proper indices for assessment of gingival & periodontal status (pre-treatment) | ||
15. | Use of proper indices for assessment of gingival & periodontal status (at each observation time) | ||
16. | Oral hygiene regime: mentioned | ||
17. | Prophylaxis done (pre-treatment) | ||
18. | Prophylaxis done (at each observation time) | ||
II. Study measurements | |||
1. | GCF handling characteristics: explained | ||
2. | Measurement method: appropriate to the objective | ||
3. | Reliability: adequate level of agreement | ||
III. Statistical analysis | |||
1. | Dropouts: dropouts included in data analysis | ||
2. | Statistical analysis: appropriate for data | ||
3. | Confounders: confounders included in analysis | ||
4. | Statistical significance level: P value stated | ||
5. | Confidence intervals provided | ||
IV. Study results and conclusions (3) | |||
1. | Index test compared to baseline | ||
2. | Index test compared to control | ||
3. | Conclusions: specific |
*Index test: Refers to collection of GCF at each observation interval in treatment teeth.