Martignon 2006.
| Methods | Split‐mouth randomised controlled trial Partially funded by Colfuturo and the Universidad El Bosque Radiographic follow‐up after 18 months Drop‐out 12% after 18 months Setting: dental schools in Denmark and Colombia |
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| Participants | 82 participants (age range 15‐39 years) attending dental faculties in Copenhagen (N = 43) or Bogota (N = 39) with mostly moderate (62% in Denmark and 61% in Colombia) or high (28% in Denmark and 33% in Colombia) caries risk Inclusion criteria: individuals with at least two initial proximal lesions in enamel up to outer third of dentine on the bitewing radiographs and corresponding bleeding after gentle probing in the gingiva next to the lesion |
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| Interventions | Two treatment arms: Group 1: resin sealant (Gluma One Bond, Heraeus Kulzer, Hanau, Germany, or Concise, 3M Espe) + flossing advice Group 2: flossing advice If necessary, a proximal temporary space was created by means of an elastic orthodontic band placed in the proximal space concerning the selected test lesion for 2 days. At the second appointment, the surface was cleaned, cotton rolls used for partial isolation, a matrix band placed around the lesion tooth or the neighbouring tooth surfaces were covered with a Teflon tape, a wooden edge was placed in the interdental space, the sealing material was applied with the aid of applicator tips and dental floss, the sealants light cured, and the surface polished. |
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| Outcomes | Radiographic progression as assessed by scoring (1 = enamel, 2 = around enamel‐dentine junction, 3 = outer third dentine, 4 = inner third, 5 = not assessable, 6 = restored) by a blinded independent examiner Radiographic progression as assessed by pairwise radiographic reading: A blinded independent examiner was asked to determine the progression status of the right positioned against the left positioned radiograph, with a further randomisation concerning the position of baseline or follow‐up images. Radiographic progression as assessed via digital subtraction radiography using Compare software (Dental Health Unit, University of Manchester, United Kingdom) by an external trained examiner 10 days after the visual assessment of conventional radiographs None of the secondary outcomes were reported. Authors did not state if they measured adverse events and none were reported. |
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| Notes | The contact area was wide in most test (75%) and control (88%) lesions. Test and control lesions differed with respect to tooth types (more test lesions on premolars), depth of the lesions (more test lesions were scored 3), location in the jaw (more control lesions were located in the lower jaw) and proximal surface area (more control lesions were on surfaces with a wide contact area to the neighbouring tooth). Intraexaminer reproducibility for the visual independent readings were kappa of 0.84 and 96% agreement; for the paired readings, kappa was 0.44 and the agreement 68%; and for the subtraction readings kappa was 0.87 and agreement 92%. |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "A random number table was used." |
| Allocation concealment (selection bias) | Unclear risk | No information provided |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | No indication for blinding of operator or participants |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "assessed by an external examiner who was blinded" |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Missing data rate 12% (< 25%) |
| Selective reporting (reporting bias) | Low risk | No indication for reporting bias |
| Other bias | Low risk | No indication for other bias |