Comparative Analysis of Different Protocols for Dental Exactions in Patients at Risk of MRONJ: Case-control Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 117
- 试验地点
- 1
- 主要终点
- Healing Evaluation Using Inflammatory-Proliferative-Remodelling Scale (IPR Scale): Inflammatory Phase
研究概览
简要总结
Medication-related osteonecrosis of the jaw (MRONJ) is a serious adverse reaction of antiresorptive and antiangiogenic agents; it is also a potentially painful and debilitating condition. Today, no specific studies have prospectively evaluated the efficacy of its treatment and no robust standard of care has been established.
Among non-invasive procedures to treat MRONJ, the use of medical ozone (O3) arises for its properties and has been deployed and evaluated. O3 has generally proven to play a role in the treatment of chronic, nonhealing, or ischemic wounds, due to its antimicrobial and anti-oxidant properties and to bio-stimulation; it has been extensively used for different medical approaches and purposes. In oral cavity, local applications are carried out by ozonized water (i.e. spray or compress) or gel.
The aim of this study was to carry out a case-control study in order to compare two different protocols of dental extractions in patients at risk of MRONJ, with and without infiltration of a mixture of oxygen-ozone.
All the cases in our study are cancer and oncologic and osteometabolic patients undergoing high-risk therapy for MRONJ (antiresorptive and antiangiogenic drugs) who require dental extractions with a poor prognosis. During the first examination (T0), medical, pharmacological, and dental history of patients are recorded. Data collected are: (1) age; (2) gender; (3) indications for use, type, cumulative dose and duration of MRONJ-related drugs; (4); history of chemotherapy; (5) other medications; (6) other diseases; (7) smoking.
For each patient, an orthopantomography and a cone beam computed tomography of the teeth are performed only if indicated.
详细描述
The enrolled patients were randomly divided into two groups:
Group A: consisting of 38 patients (undergoing ozone treatment) (OZONE_EXO) intra-tissutal perialveolar injections of a 15-mL mixture of OxigenOzone (O2O3) with a 26Gx1⁄2 - 0.45x13 mm needle and insufflation of the same mixture in the post-extraction site in patients at risk of medication-induced osteonecrosis of the jaw (ONJ).
Group B: comprising 79 controls (not undergoing ozone treatment).(NO_OZONE_EXO) Tooth extraction in patients at risk of medication-induced osteonecrosis of the jaw (ONJ) without the use of ozone application.
Following the same approach as in Group A, patients in Group B underwent additional follow-up visits at T1 (3-5 days), T2 (14 days), and T3 (6 weeks) post-extraction, in accordance with Inflammatory - P roliferative - Remodeling (IPR) Wound Healing Scale.
the IPR scale score, to meticulously monitor surgical wound healing and record pain intensity using the NRS scale, rather than the originally planned VAS scale, for enhanced ease of use [22].
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age ≥ 18 yrs
- •patients at risk of developing MRONJ for previous or current administration of drugs related
- •extraction of teeth with a poor prognosis due to severe decay and/or periodontitis
排除标准
- •previous radiation in the head and neck area
- •neoplastic involvement of the jaw
- •previous MRONJ diagnosis
研究组 & 干预措施
Group A (OZONE_EXO)
intra-tissutal perialveolar injections of a 15-mL mixture of OxigenOzone (O2O3) with a 26Gx1⁄2 - 0.45x13 mm needle and insufflation of the same mixture in the post-extraction site in patients at risk of medication-induced osteonecrosis of the jaw (ONJ).
干预措施: OxigenOzone_Insufflation (Biological)
结局指标
主要结局
Healing Evaluation Using Inflammatory-Proliferative-Remodelling Scale (IPR Scale): Inflammatory Phase
时间窗: 3-5 days after the intervention
The inflammatory phase is evaluated 3-5 days after tissue injury on the basis of eight parameters, measured on a 9-point scale (0-8): bleeding (spontaneously or on palpation), granulation tissue, hematoma, tissue color, incision margins, suppuration, edema, and pain. A score of 5-8 indicates a successful inflammatory phase
Healing Evaluation Using Inflammatory-Proliferative-Remodelling Scale (IPR Scale): Proliferative Phase:
时间窗: 14 days after the intervention
The proliferative phase is evaluated 14 days after tissue injury on the basis of five parameters, measured on a 6-point scale (0-5): re-epithelialization, tissue color, scar, suppuration, and pain. A score of 3-5 score indicates successful healing.
Healing Evaluation Using Inflammatory-Proliferative-Remodelling Scale (IPR Scale): Remodelling Phase
时间窗: 6 weeks after the intervention
The remodeling phase is evaluated 6 weeks after tissue injury on the basis of three parameters, measured on a 4-point scale (0-3): scar, tissue color, and pain. A score of 2-3 indicates successful healing
次要结局
- Healing Evaluation Using IPR Scale: Total Process(6 week)
研究者
Olga Di Fede
Professor
University of Palermo