K02.0
Conditions
Interventions
Group 1: Control group
-Education on dietary habits.
-Oral hygiene instruction, advice to use fluoride toothpaste (1450 ppm daily) and Elmex gel (12500 ppm) once a week at home.
-Professional flossin
3M) vestibularly and orally in the immediate proximity of the initial approximal lesion, in case of loss or partial loss reapplication will be performed in recall visits.
Sponsors
Universität Greifswald, Zentrum für Zahn-, Mund- und Kieferheilkunde, Poliklinik für Kinderzahnheilkunde
Eligibility
Sex/Gender
All
Age
6 Years to 17 Years
Inclusion criteria
Inclusion criteria: 1) Children with high risk of caries. 2) Cooperative children. Only Code 3 and 4 according to Frankl behavior rating scale 3) Children willing to actively participate and appear to follow-up 4) The existence of the written declaration of consent of the study participants or their legal guardians. - Inclusion criteria for tooth selection 1) ?Primary molar or permanent molar or premolar with initial proximal caries lesions ?extending radiographically to the enamel ?(E1, E2), or the outer one third of dentine, just passing the EDJ (D1). (Young et al., 2015) 2) Activity of the lesion: bleeding on probing in the proximal area of the lesion will be used as a criterion to assess the activity of the lesion.
Exclusion criteria
Exclusion criteria: 1) Children with general diseases and allergies. 2) Patient with dry mouth. 3) Patients who have already bitewings no older than 9 months but older than 1 month 4) Children whose parents are not willing to participate in the study, and refuse to return back for follow-up visits and most importantly after 12 months for a second bitewing radiograph.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Radiological assessment of lesion progression after 1 year. Bitewing radiographs will be taken through the x-ray unit and a film sensor which will be stabilized through a sensor holder. When feasable, bite registration will be recorded through a silicone material on the plastic part of the holder where the patient bites in order to achieve standardization /reproducability of the bitewing radiograph. When applied and stable, the silicon material will be stored with the plastic portion in a plastic bag labeled with the patient’s ID number inside a refrigerator until the follow-up after a year. X-ray evaluation will be performed by two dentists at the end of the trial (12 months follow-up). In order to make the investigators blinded in the evaluation of the bitewing radiograph, the RMGIC will be dislodged with the use of an ultrasonic scaler before taking the X-ray, so that they will not be visible bitewing. Three dentists will be asked for testing the reliability of reading bitewings. Each dentist will have to evaluate separately ten proximal radiographs twice at different points and intra-examiner reliability will be assessed. The gold standard will be defined as the most frequent readings of these three dentists and inter-examiner reliability will be calculated. The two dentists who have the best intra- and inter-examiner evaluation will be chosen for radiographic measurements. | — |
Secondary
| Measure | Time frame |
|---|---|
| I. RMGIC strip quality assessment will be performed through the modified Ryge criteria (Cvar & Ryge, 2005) on retention, discoloration, and marginal interface between the enamel and the RMGIC-strip. In addition, surface roughness of the RMGIC patch will be assessed. Reapplication of RMGIC will be considered in each recall visit if the assessment shows shifting from alpha to charlie or delta. Retention: Alpha: no loss Bravo: partial loss (less than 50% of the strip) Charlie: partial loss (more than 50% of the strip) Delta: total loss Marginal interface: Alpha: The explorer probe does not “catch” or if a “catch” exists, there is no visible crevice along the periphery of the restoration Bravo: The explorer does “catch” and there is visible evidence of a crevice into which the explorer will penetrate Charlie: Step like loss of retention. The explorer penetrates into crevice indicating that a space exists between the restoration and the tooth structure Marginal discoloration: Alpha: There is no visual evidence of marginal discoloration. Bravo: There is visual evidence of marginal discoloration at the junction of the tooth structure and the material, but the discoloration has not penetrated along the restoration. Charlie: There is visual evidence of marginal discoloration at the junction of the tooth structure and the material that has penetrated along the material in a pulpal direction. color/Discoloration of RMGIC-strip: Alpha: Match of color and translucency compared to neighboring tooth tissue. Bravo: Slight mismatch. Charlie: Complete mismatch. Surface roughness: Alpha: Surface texture similar to polished enamel as determined by means of a sharp explore Bravo: Surface texture gritty or similar to a surface subjects to a white stone Charlie: Surface pitting is sufficiently coarse to inhibit the continuous movement of an explorer across the surface II. Vitality test, Plaque and gingival status will be assessed around the Resi | — |
Countries
Germany
Contacts
Public ContactJulian Schmoeckel
Universitätsmedizin Greifswald, Zentrum für Zahn-, Mund- und Kieferheilkunde; Poliklinik für Kinderzahnheilkunde
Outcome results
None listed