Effectiveness of optradam versus conventional rubber dam isolation on dental anxiety in children– a randomized clinical study

Abstract Background Effective isolation is essential for successful pediatric dental treatment; however, conventional rubber dam placement may increase discomfort and anxiety because of clamp application. OptraDam, a clamp-free isolation system, has been introduced to improve patient comfort while maintaining adequate moisture control. This study compared the effects of OptraDam and conventional rubber dam on anxiety and physiological stress in children undergoing pulpotomy. Methods In this randomized clinical trial, 44 children requiring pulpotomy of primary molars were randomly allocated to treatment with either OptraDam ( n = 22) or a conventional rubber dam ( n = 22). Dental anxiety was assessed as the primary outcome using the Venham Anxiety Scale before and after treatment. Secondary outcomes included heart rate as a physiological measure and the Sound–Eye–Motor (SEM) scale as a behavioral measure. Chi-square tests were used to compare sex distribution, while independent-samples t-tests were used for baseline between-group comparisons and paired-samples t-tests for within-group changes. Between-group differences in changes from baseline to post-intervention were assessed using independent-samples t-tests of change scores, with mean differences and 95% confidence intervals reported. ANCOVA was used to compare post-intervention Venham Anxiety Scale scores and heart rate between groups after adjustment for baseline values. Statistical significance was set at P < 0.05. Results The two groups were comparable regarding age, sex distribution, baseline Venham anxiety scores, and heart rate. SEM scores assessed during the pulpotomy procedure were significantly lower in the OptraDam group than in the conventional rubber dam group. Within the OptraDam group, anxiety and heart rate showed nonsignificant reductions following treatment. In contrast, the conventional rubber dam group demonstrated significant increases in both anxiety and heart rate. After adjustment for baseline values, post-treatment anxiety and heart rate were significantly lower in the OptraDam group than in the conventional rubber dam group. To directly compare changes from baseline to post-intervention between the two groups, change scores were calculated as baseline minus post-intervention values. For the Venham Anxiety Scale, the mean change was 0.68 ± 1.64 in the OptraDam group and − 1.41 ± 1.82 in the conventional rubber dam group. The between-group difference in mean change was 2.09 points (95% CI, 1.04 to 3.15; P < 0.001). For heart rate, the mean change was 4.23 ± 10.45 beats/min in the OptraDam group and − 18.91 ± 6.58 beats/min in the conventional rubber dam group, corresponding to a between-group difference of 23.14 beats/min (95% CI, 17.79 to 28.48; P < 0.001).After adjustment for baseline values using ANCOVA, post-intervention Venham Anxiety Scale scores were significantly lower in the OptraDam group than in the conventional rubber dam group ( P < 0.001). Similarly, adjusted post-intervention heart rate was significantly lower in the OptraDam group than in the conventional rubber dam group ( P < 0.001). Conclusions Compared with conventional rubber dam isolation, OptraDam was associated with lower anxiety-related behavioral and physiological responses in children undergoing pulpotomy. However, because comfort, treatment acceptance, moisture control, and isolation quality were not directly assessed, these findings should not be interpreted as evidence of superiority with respect to these outcomes. Larger multicenter studies involving more diverse pediatric populations are needed to confirm the findings. Trial registration Iranian Registry of Clinical Trials (IRCT), IRCT20250308064976N2 registered 27 July 2025.