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临床试验/NCT06667362
NCT06667362已完成不适用

Frequency of Periodontal Disease in Head and Neck Cancer Patients After Radiation Therapy: a Cross Sectional Study

Ain Shams University1 个研究点 分布在 1 个国家目标入组 189 人开始时间: 2023年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
189
试验地点
1
主要终点
Clinical Attachment Loss (CAL)

研究概览

简要总结

This prospective cross-sectional study evaluates the frequency and risk factors of periodontal disease in head and neck cancer patients who have undergone radiotherapy. 189 patients from three radiation centers in Cairo Governorate, Egypt will be included in the study. Periodontal status will be assessed according to the 2017 classification of periodontal diseases. Data will be collected through interviews, clinical examinations, and medical records. Potential risk factors, including tumor characteristics, treatment modalities, and oral health behaviors, will be analyzed. The findings aim to provide insights into the oral health challenges faced by these patients and inform better clinical management strategies.

详细描述

Introduction Cancer accounts for 12% of global deaths and poses a significant health challenge, with over 10 million new cases and 6 million fatalities annually worldwide [1]. Among them, head and neck neoplasia (HNN) is a major form of cancer in India, accounting for 23% of all cancers in males and 6% in females; Depending upon the sub-site of origin and the clinical extent of the disease the 5 -year survival varies from 20% to 90% [2]. The three most common modalities used in head and neck cancer treatment are surgical resection, radiotherapy and chemotherapy, either used singly or in combination. While these modalities are effective in eliminating the tumor, they also adversely affect the normal head and neck structures surrounding the tumor. Radiation therapy has cytotoxic effects on both normal cells and malignant cells. Direct damage to the oral structures (soft and hard tissue) commonly occurs from radio- and chemotherapy, and indirect damage may also occur from systemic toxicity. These oral complications may arise during and following cancer treatment and are commonly grouped into two broad categories: acute and chronic [3].

The reported acute oral complications are mucositis, xerostomia, dysphagia, dysgeusia, and opportunistic infections, and chronic complications such as trismus, irradiation caries, osteoradionecrosis, and changes in periodontal attachment. The long-term effects comprise alteration in vascularity of soft tissue and bone, salivary gland damage, reduction in cellularity of connective tissue, and risk of increased collagen synthesis which results in fibrosis [4]. Radiation treatment induces obliterative end- arteritis that results in soft tissue ischemia and fibrosis while the irradiated bone become hypo vascular and hypoxic [5]. The periodontium is sensitive to the effect of radiation at high doses. Diminished vascularity and cellularity of the periodontal ligament membrane with widening of periodontal space, thickening, rupturing, and disorientation of Sharpey s fibers have been reported [6].

The direct and indirect effect of high-dose radiotherapy (RT) on the periodontium results in greater risk of periodontal attachment loss and tooth loss and greater risk for the development of osteoradionecrosis[7]. The extensive periodontal destruction may occur in the absence of good oral hygiene. Periodontitis in patients scheduled for head and neck radiotherapy results in acute and chronic complications such as osteoradionecrosis. Maintenance of good oral hygiene in patients undergoing radiotherapy may reduce morbidity of the known oral and periodontal side effects [8].

Patient stated to receive the head and neck radiation therapy need dental consultation at the earliest possible time. Pre-irradiation treatment depends on patient prognosis, compliance, and residual dentition, in addition to fields, ports, dose and immediacy of radiotherapy. Diseases of teeth and supporting structures are a worrying finding in a patient about to undergo tumoricidal radiotherapy for a malignant condition in the maxillofacial region because oral pain and infection are common and a potentially serious sequence to radiotherapy for head and neck tumors in patients with healthy mouth. The loss of integrity of the gingival crevicular tissues, as a result of periodontitis and radiotherapy induced thinning of these tissues together with xerostomia, mucositis, altered diet, and poor oral hygiene that often follow high-dose radiotherapy to the jaws, can create oral problems that affect the quality of life, which can cause interruption to cancer therapy [9].

The periodontal blood vessels are affected by radiation leading to widening of periodontal ligament space and destruction of bony trabeculae which may result in increased risk of periodontal disease and altered healing with diminished capacity for bone remodeling and repair [10]. Llory et al., showed a radiation-induced downshift of periopathogens [11]. Markitziu et al. [12] and Leung et al. [13] reported that due to radiation induced hypo-salivation and a concomitant increase in plaque accumulation and shift in oral micro flora the risk of periodontal infection is also increased. Shwarze et al., found a greater number of shallow periodontal pockets in radiated patients [14]. The reduced probing pocket depth does not indicate the histological pocket depth since the probe generally penetrates coronal level of junctional epithelium due to inflammation of underlying connective tissue or may be due to disparity between probing technique, probing force, or angle of insertion of the probe [8].

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Cross Sectional

入排标准

性别
All
接受健康志愿者

入选标准

  • Over 18 years of age Any gender At least six remaining teeth Undergoing head and neck radiotherapy with or without chemotherapy for 6-7 weeks Head and neck malignancy including squamous cell carcinoma of the tongue, buccal mucosa, hard palate, soft palate, and base of tongue.
  • Both mandible and maxilla included in the radiation field

排除标准

  • Major surgical intervention (major hard tissue resection) Psychiatric disorders Distant metastatic disease Bone-related disorders Active untreated infection Palliative care Pregnancy Smokers

结局指标

主要结局

Clinical Attachment Loss (CAL)

时间窗: Measured once during the study.

The distance from the cementoenamel junction (CEJ) to the bottom of the periodontal pocket. It indicates the amount of attachment loss due to periodontal disease. Measured with a periodontal probe at six sites per tooth.

Probing Depth (PD)

时间窗: Measured once during the study.

The distance from the gingival margin to the bottom of the periodontal pocket. Measured with a periodontal probe at six sites per tooth.

Bleeding on Probing (BOP)

时间窗: Assessed once during the study.

Presence or absence of bleeding from the gingival sulcus 10 seconds after probing with a standardized force. Assessed at six sites per tooth.

Plaque Index (PI)

时间窗: Assessed once during the study.

A score reflecting the thickness of dental plaque present at the gingival margin. Assessed using a Williams periodontal probe and scored on a scale of 0 to 3 (0=no plaque, 3=dense plaque).

Tooth Loss due to Periodontitis

时间窗: Assessed through patient history, so it covers the period prior to the study.

Tooth Loss due to Periodontitis

Radiographic Bone Loss

时间窗: Radiographs taken once during the study.

Assessed through radiographic examination to determine the extent of bone loss around the teeth. Used in conjunction with CAL to stage periodontitis.

次要结局

  • Clinical Oral Dryness Score (CODS)(Assessed once during the study.)
  • Unstimulated Salivary Flow Rate(Saliva collected once during the study, between 8:00 AM and 11:00 AM.)
  • Oral Mucositis (OM)(Assessed once during the study)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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