Use of rubber dam versus cotton roll isolation on composite resin restorations’ survival in primary molars: 2-year results from a non-inferiority clinical trial

Table 2 Primary outcome analysis (restoration survival) using non-inferiority Cox Regression and Intention-to-treat analyses

Outcomes	RDI	CRI	p value
Primary outcome—Non-Inferiority Cox Regression analysis*
% Survival	60.41%	54.31%	0.036
HR (90% C.L. of HR)	1.33 (0.88–1.99)
Primary outcome—Intention-to-treat analysis (2 years) **
N success/N total	54/86	51/88	0.003
% Success	62.79%	57.95%
Absolute difference (95%CI)	0.05 (− 0.09 to 0.19)
OR (95%CI) **	1.22 (0.67–2.25)		0.201

HR = Hazard Ratio; OR = Odds ratio
Ha = non-inferiority at α = 5%
^* 100(1−2α)% Confidence Interval and p-value for non-inferiority survival data (Wald test)
^** p values and 95% CI were derived by Miettinen and Nurminen’s method using non-inferiority test for two proportions

ISSN: 1472-6831