Gomez 2005.
| Methods | Clustered split‐mouth randomised controlled trial Part of a bigger study involving a total of 50 participants Radiographic follow‐up after 2 years Drop‐out 0% after 2 years Setting: navy dental clinic in Chile |
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| Participants | 7 participants (72% male, 28% female), mean age 15 years (range 10‐20), with unclear caries risk; 71 lesions randomly allocated to intervention or control. Inclusion criteria: radiographic detection of one or more surface with incipient proximal carious lesions on molars and premolars Unclear who performed initial examination |
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| Interventions | Two treatment arms: Group 1: resin sealant (Concise, 3M Espe, Neuss, Germany) Group 2: application of fluoride varnish twice yearly In group 1, access was first gained to confirm the presence of enamel lesions and their clinical status by temporary tooth separation. After 1–2 days, the surface was cleaned, dried and a cotton roll or rubber dam applied. The carious tooth area and the 1 mm enamel surrounding the lesion were etched for 20 s with a 35% phosphoric acid gel, washed and dried, whilst the adjacent surface was protected with a nylon adhesive strip. When the proximal surface was completely dried, a light‐cured, low‐viscosity pit and fissure was applied using a brush. After 30 s, the sealant was light cured. During sealing, dental floss was placed in the interdental sulcus space to avoid sealant flow to the cervical zone. After sealing, excess sealant was removed with an explorer, and the margins polished with a fine polishing strip. |
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| Outcomes | Radiographic progression according to scoring (0 = no visible radiolucency; 1 = radiolucency in the enamel; 2 = radiolucency in the outer half of the dentine; 3 = radiolucency in the inner half of the dentine; and 4 = restoration). Authors did not state if they measured adverse events and none were reported. |
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| Notes | Intraexaminer reliability showed a kappa of 0.86 when the calculations included carious surfaces (scores 1–4). For surfaces with score 1, kappa was 0.84. Clustering of lesions and unequal distribution; unclear lesion depths |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "Random numbers were used to decide which surfaces should be treated with sealant or fluoride varnish." |
| Allocation concealment (selection bias) | Unclear risk | No information provided |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | No blinding reported |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "Radiographs were analysed blindly in a random order by one observer." |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Missing data rate 0% after 2 years (< 25%) |
| Selective reporting (reporting bias) | Low risk | No indication for selective reporting |
| Other bias | High risk | Unclear how lesion depths distributed in groups; severe clustering of lesions |