RhPTH1-34 In The Treatment Of Osteoradionecrosis Of The Jaws-A Clinical Trial

Objective: The purpose of this study was to investigate the clinical effect of teriparatide on osteoradionecrosis of the jaws(ORNJ).Methods: According to the inclusion and exclusion criteria,established ORNJ who were treated in the Affiliated Stomatology Hospital of Kunming Medical University from January 2019 to April 2023 were selected and divided into control group and teriparatide group.The control group only received basic treatment(including excision of lesions,local washing,chlorhexidine mouthwash,antibiotic treatmen and surgical treatment when necessary),while the teriparatide group received subcutaneous injection of teriparatide(20ug/day)for 2 months at the same time as basic treatment as the control group.The main indicators of observation were wound healing,jaw bone regeneration in the region of necrotic bone,clinical staging,and bone mineral density.Secondary indicators include bone metabolism markers bone resorption marker C-terminal telopeptide of type I collagen,N-terminal osteocalcin,blood calcium,parathyroid hormone and Oral Health Impact Profile-14 score.The measured data were statistically analyzed using IBM SPSS Statistics22.0 software.Result: There were 19 ORNJ patients,including 11 males and 8 females,aged from37 to 72 years old,with an average of 57.8±9.41 years old.There were seven patients in control group and twelve in teriparatide group.In the course of treatment,two patients in teriparatide group withdrew from the research due to drug allergy and stroke,while the remaining ten experienced no side effects.The demographic and clinical characteristics of the 15 participants were generally similar(P > 0.05).During the follow-up period,the upward trend of N-terminal osteocalcin in the teriparatide group was higher than that in the control group at each period(P=0.164).Compared with the control group,the C-terminal telopeptide of type I collagen in the teriparatide group increased at the first month(P=0.083),but began to decrease in the sixth(n=3)and 12 th months(n=4)(P= 0.072 and 0.041).There was no significant difference in parathyroid hormone and serum calcium between the two groups.After treatment,the bone mineral density of the teriparatide group increased by an average of 103HU(P=0.028).The overall average score of the clinical stage in the teriparatide group(1.00)was significantly lower than that in the control group(2.57)(P=0.041),and the overall average score of oral health in the teriparatide group(19.9)was significantly lower than that in the control group(28.1)(P=0.038).The trend of improvement in the teriparatide group was faster than that in the control group(P=0.030).There were 5 patients in the teriparatide group with obvious new bone repair in the sequestrum area,and the cure rate(33.3%)was significantly higher than that in the control group(14.3%)(P=0.032).Conclusion: Based on conventional treatment(including lesion removal,location washing,chlorhexidine gargling,and oral antibiotics administration for a week)teriparatide can improve wound healing and new bone regeneration in patients with ORNJ,and it can be considered an adjuvant treatment for ORNJ.