Cruz 2016.
Methods |
Design: cluster, parallel RCT (a child is a cluster) Number of participants: 75 Setting: nursing home Country: Colombia Unit of randomisation: participant Unit of analysis: tooth Follow‐up: 6 months Dropout: 14.9 % after 6 months |
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Participants |
Number randomised: 75 participants; 174 teeth (73 ART group and 101 CT group)
Number analysed: 64 participants/148 teeth
Age mean and SD (range): 74.9 years (60‐101)
Sex: female 36 (48%), male 39 (52%) Average DMFT score: not reported Dentition: permanent Type of caries lesion: root caries Inclusion criteria: root caries defined as the softening of the root dentin to a depth of ≥ 0.5 mm Exclusion criteria: teeth with extraction indication, lesion close to the dental pulp or pain symptomatology |
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Interventions | Two treatment arms:
ART was performed using only manual instrumentation to remove decayed tissue. Cotton rolls and a retraction cord were used to obtain relative isolation of the operative field. 2% chlorhexidine (Clorhexol 0.2 g/100 mL; Farpag®, Bogota, Colombia) was applied for 1 min and the cavity was dried and sealed with aglass ionomer cement modified with light‐curing composite resin (Vitremer™®, 3M ESPE, Seefeld, Germany). Interproximal metal and paper strips were used. Conventional technique was performed using a high‐speed handpiece with irrigation and round diamond burs of different diameters. Cavities were restored with RM‐GIC. Use of anaesthesia was not reported in any group. The interventions were conducted by 2 dentists. |
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Outcomes |
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Notes | Funding: COLCIENCIAS for the Young Researcher Scholarship‐Internship Program Trial register number not reported Sample size calculated Intraexaminer and interexaminer reproducibility not assessed |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "A series of random numbers was used to fabricate sealed envelopes that were only opened for the random allocation of the participants to each working group (ART or conventional technique with rotary instruments)" |
Allocation concealment (selection bias) | Low risk | Quote: "A series of random numbers was used to fabricate sealed envelopes that were only opened for the random allocation of the participants to each working group (ART or conventional technique with rotary instruments)" |
Blinding of participants and personnel (performance bias) ‐ participant | High risk | Comment: no information provided, but the participants could tell whether manual or rotary instruments were used |
Blinding of participants and personnel (performance bias) ‐ operator All outcomes | High risk | Comment: blinding not possible ‐ operator knew the intervention |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "After six months, the condition of the restorations was assessed by two different prosthodontists, without awareness of the technique that was performed in each participant" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "After six months, 64 participants were evaluated (32 men and 32 women) and 26 restorations (14.9%) were lost. Seven participants changed geriatric institutions and were lost to follow‐up, two died, and the two remaining participants were unreachable at the institution during the time of revision” |
Selective reporting (reporting bias) | Low risk | Comment: all outcomes listed in the methods sections were included. |
Other bias | High risk | Comment: no information provided about baseline characteristics of included participants. The analysis did not consider the pair data. |