Clinical relevance of the use of Dentoxol® for oral mucositis induced by radiotherapy: A phase II clinical trial

Table 1 Absolute frequencies and percentages of patients with and without severe oral mucositis by follow-up week

Week	Dentoxol® (n = 55)				Control (n = 53)
	No severe oral mucositis		Severe oral mucositis		No severe oral mucositis		Severe oral mucositis		P value
	n	%	n	%	n	%	n	%
1	49	94.2	3	5.8	49	98.0	1	2.0	0.327
2	49	100	0	0.0	42	95.5	2	4.5	0.131
3	47	95.9	2	4.1	30	76.9	9	23.1	0.007a
4	42	91.3	4	8.7	29	70.7	12	29.3	0.013a
5	33	73.3	12	26.7	19	52.8	17	47.2	0.055
6	29	64.4	16	35.6	15	46.9	17	53.1	0.125
7	22	57.9	16	42.1	11	44.0	14	56.0	0.280
8	11	57.7	6	35.3	4	44.4	5	55.6	0.320

^aStatistically significant.

Table 2 Odds ratio were calculated using a contingency table

	Severe oral mucositis	No severe oral mucositis	Total
Dentoxol®	a	b	a + b
Control	c	d	c + d
Total	a + c	b + d	a + b + c + d

a: Number of patients who presented severe oral mucositis and received Dentoxol^® treatment; b: Number of patients who did not present severe oral mucositis and received Dentoxol^® treatment; a + b: Total number of patients in the Dentoxol^® group; c: Number of patients who presented severe oral mucositis and received control treatment; d: Number of patients who did not present severe oral mucositis and received control treatment; c + d: Total number of patients in the control group.

Table 3 Measures of clinical significance for the effect of Dentoxol^® on severe oral mucositis

Week	AR		RR (95%CI)	ARR	RRR	NNT	OR (95%CI)
	Dentoxol (%)	Control (%)	Dentoxol®	Dentoxol® (%)	Dentoxol® (%)	Dentoxol®	Dentoxol®
1	5.77	2	2.88 (0.31-26.82)	-4	-188	-27	3 (0.30-29.85)
2	0	4.55	-	5	100	22	-
3	4.08	23.08	0.18 (0.04-0.77)	19	82.31	5	0.14 (0.03-0.70)
4	8.7	29.27	0.3 (0.1-0.85)	21	70.29	5	0.23 (0.07-0.78)
5	26.67	47.22	0.56 (0.31-1.02)	21	43.53	5	0.41 (0.16-1.03)
6	35.56	53.13	0.67 (0.4-1.12)	18	33.07	6	0.49 (0.29-1.23)
7	42.11	56	0.75 (0.45-1.25)	14	24.81	7	0.57 (0.21-1.58)
8	35.29	55.56	0.64 (0.27-1.52)	20	36.47	5	0.44 (0.08-2.27)

ARR: Absolute risk reduction; RR: Relative risk; RRR: Relative risk reduction; NNT: Number necessary to treat; OR: Odds ratio.