Clinical evaluation of the performance of a composite material used in the warmingtechnique - Composite Warming

Forty-seven of the 50 subjects were evaluated for the 36-month follow-up visit, which presents a current dropout rate of six percent. One subject moved abroad and could not attend the 36-month follow-up, consequently being considered a dropout. One subject should have shown up at scheduled recall appointments. After repeated attempts to contact the subject, he was considered a dropout. One subject withdrew from the study due to medical reasons. Three restorations received a score of 4 and were considered failing. The total survival rate was 96.8% after three years, with no significant difference between the test and control groups. The majority of the evaluated parameters' scores were either 1 or 2, meaning they were clinically excellent. For the test and control groups, there was a significant difference between baseline and 36-month scores for the following parameters: surface luster, surface staining, marginal staining, color match and translucency, marginal adaptation, approximal anatomical form – contour, tooth integrity, periodontal response, and adjacent mucosa. Surface luster: The p-value for surface luster compared to baseline in both groups was <0;0001. At baseline, 72 restorations received a score of 1. At 24 months, only 18 still had a score of 1. At 12 months, that number was 25, indicating a further decrease in surface luster each year. After three years, only two restorations were considered clinically excellent, with a score of 1. These findings are in accordance with other clinical studies and may also be attributed to another evaluator scoring the restorations after baseline evaluation. Surface staining: Surface staining was significant when comparing the scores for both groups at baseline and 36 months. The p-value for the test and control groups was <0,0001. Data shows that with each year of follow-up, the number of restorations with surface staining increases. At six months, seven restorations had a score of 2, but after three years, they were 44. Marginal staining: Marginal staining was significant when comparing the scores for both groups at baseline and 36 months, with a p-value of <0,0001. At six months, 75 restorations had a score of 1. At 36 months, the number of restorations scoring 1 had dropped to 42. All restorations either scored 1 or 2 for marginal staining. Color match and translucency: The p-value for color match was <0,0001 for both groups. The most notable difference was that no restorations scored 3 at baseline, however at 36 months 31 subjects had a score of 3, just like in the previous follow up visits. Marginal adaptation: The p-value for marginal adaptation compared to baseline in both groups was <0,0001. With slight ditching or minor irregularities occurring in 64 restorations. Tooth integrity: There was a significant difference between baseline and 36 months for both test and control groups where the p value was <0,0001 for both groups. Periodontal response: For both groups the p value was <0,0001 for periodontal response. A significant difference has been observed, but at 6- and 12-months follow-up a different reference tooth was used for some subjects by mistake. For 36 and 24 months the reference tooth was the same as the one at baseline for all subjects. Adjacent mucosa: The p value for adjacent mucosa was <0,0001 for both groups. At baseline all restorations except one had score of 1 but by the time of 24 months follow up the 59 restorations had a score of 2. Three restorations were considered a failure according to the FDI criteria. The total survival rate after three years was, therefore, 96.8% A significant difference between FDI scores at 36 months versus baseline was observed in both groups for categories surface luster, surface staining, marginal staining, color match and translucency, marginal adaptation, approximal anatomical form–contour, tooth integrity, periodontal response, and adjacent mucosa. Two adverse events occurred. One subject was diagnosed with Lichen planus and was consequently referred to an oral pathologist, and another subject had caries in a study tooth. However, the caries lesion was unrelated to the study restoration, i.e., on another tooth surface. There is no statistical difference between the study groups for FDI criteria 11: Postoperative (hyper-) sensitivity and tooth vitality, highlighting the safety of the warming technique.