Paris 2010a.
Methods | Clustered split‐mouth randomised controlled trial Partially funded by DMG Radiographic follow‐up after 18 months with additional follow‐up planned after 36 and 60 months Drop‐out 0% and 9% after 18 and 36 months, respectively Setting: university dental clinic in Germany |
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Participants | 22 participants (64% female, 36% male), mean age 25 years (range 18‐35), with low (32%), moderate (36%), and high (32%) caries risk; total of 29 lesion pairs, attending the Berlin University dental clinic Inclusion criteria: presence of 2 or more non‐cavitated proximal caries lesions with radiolucencies involving the inner half of enamel up to the outer third of dentine, aged 18‐35 yrs Exclusion criteria: pregnant, participating in another study, incapable of contracting, institutionalised Radiographs taken using standardised conventional bitewing radiographs with individualised holder. One investigator scored lesions using a light box. |
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Interventions | Two treatment arms: Group 1: resin infiltration (Icon pre‐product, DMG) + fluoride varnish application + oral hygiene and dietary advice Group 2: fluoride varnish application + oral hygiene and dietary advice For group 1, rubber dam was applied, teeth were separated by plastic wedges, polyurethane foil placed in the contact area with a plastic holder to protect the adjacent tooth, 15% HCl etching gel applied by syringe in the area below the contact point for 120 s, the gel washed off with air‐water‐spray for 30 s, the lesion desiccated by air‐blowing for 10 s, ethanol applied for 10 s, the lesion desiccated using air‐blowing again for 10 s. Eventually, an infiltrant was applied and after 5 min of penetration time, excess material removed by air‐blowing and flossing. The resin was light cured for 1 min from the buccal, occlusal, and oral aspects. The infiltration step was repeated with a penetration time of 1 min. For group 2, operators performed a sham‐infiltration, with water instead of HCl gel and infiltrant. The operators, however, were aware of this. |
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Outcomes | Radiographic progression as assessed by scoring (E1 = up to outer half of enamel, E2 = up to inner half of enamel, D1 = up to outer third of dentine, D2 = up to middle third of dentine, D3 = up to inner third of dentine) of lesions at baseline and follow‐up examination Radiographic progression as assessed by pairwise assessment of lesions for progression, regression, or stability Radiographic progression as assessed by DSR Subjective and clinical adverse events, such as loss of vitality, staining, or gingival alterations were measured and none were reported. None of the other secondary outcomes were reported. |
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Notes | Inter‐rater reliability (kappa) was moderate (0.59) for radiographic staging, substantial (0.67) for pairwise comparison, and almost perfect (0.81) for DSR. Intra‐rater reliability ranged from moderate to almost perfect (0.51‐0.89). Potential industry and profession bias (the trialists are appointed as inventors and patent‐holders of the technique) |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "From each pair, 1 lesion was allocated to the test and 1 to the control group, respectively, by computer‐generated randomly permuted blocks." |
Allocation concealment (selection bias) | Low risk | Quote: "in sealed envelopes" |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote: "Patients were blinded to lesion allocation throughout the whole study period as a placebo treatment was performed on the control lesions." Comment: Operators were not necessarily blinded, but it is unclear how this might affect outcomes. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "Examiner was blinded with regard to treatment group allocation of teeth." |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Missing data rate 9% (< 25%) after 3 years |
Selective reporting (reporting bias) | Low risk | No indication for reporting bias |
Other bias | Low risk | No indication for other bias |