Efficacy and safety of rhBMP/β-TCP in alveolar ridge preservation: a multicenter, randomized, open-label, comparative, investigator-blinded clinical trial

Maxillofacial Plastic and Reconstructive Surgery

Table 7 Incidence of adverse events by systemic organ class and preferred term

	Test group (N = 43)	Control group (N = 45)	Total (N = 88)
Patients with adverse events	2 (4.65) [2]	7 (15.56) [11]	9 (10.23) [13]
Gastrointestinal disorders	1 (2.33) [1]	4 (8.89) [4]	5 (5.68) [5]
Toothache	0	2 (4.44) [2]	2 (2.27) [2]
Gingival bleeding	1 (2.33) [1]	0	1 (1.14) [1]
Gingival pain	0	1 (2.22) [1]	1 (1.14) [1]
Sensitivity of teeth	0	1 (2.22) [1]	1 (1.14) [1]
Nervous system disorders	0	2 (4.44) [2]	2 (2.27) [2]
Hepatic encephalopathy	0	1 (2.22) [1]	1 (1.14) [1]
Lumbosacral radiculopathy	0	1 (2.22) [1]	1 (1.14) [1]
Metabolism and nutrition disorders	0	1 (2.22) [1]	1 (1.14) [2]
Hypoalbuminemia	0	1 (2.22) [1]	1 (1.14) [1]
Hypomagnesaemia	0	1 (2.22) [1]	1 (1.14) [1]
Infections and infestations	0	1 (2.22) [1]	1 (1.14) [1]
Periodontitis	0	1 (2.22) [1]	1 (1.14) [1]
Investigations	0	1 (2.22) [1]	1 (1.14) [1]
Blood glucose increased	0	1 (2.22) [1]	1 (1.14) [1]
Skin and subcutaneous tissue disorders	1 (2.33) [1]	0	1 (1.14) [1]
Pruritus	1 (2.33) [1]	0	1 (1.14) [1]

Patients with adverse events are presented as “number of patients (percentage of patients) [number of events]” and others are presented as “number of events”