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临床试验/CTRI/2024/11/077083
CTRI/2024/11/077083招募中3 期

Efficacy of biotene oral balance system and xerostom salivary system on salivary properties, salivary biomarkers (beta- defensin, mucin-7) and caries susceptibility in patients with irradiation induced xerostomia: a single blinded randomized controlled trial

DrAnam Alam1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2024年11月30日最近更新:
适应症

试验速览

阶段
3 期
状态
招募中
发起方
入组人数
66
试验地点
1
主要终点
Increase in the salivary flow, pH & buffering capacity & decrease in the caries susceptibility

研究概览

简要总结

Head and neck carcinoma (HNC) is the sixth most common cancer worldwide,accounting for 2.8% of all malignancies. Approximately 6,30,000 patients arediagnosed each year with an annual death rate of 3,50,000. Radiotherapy (RT) plays a pivotal role in the curative treatment in themajority of patients of head and neck cancer either as a single modality or inconjunction with surgery. Despite the beneficial aspects of radiotherapy inlocoregional tumor control, the damage inflicted to normal tissues surroundingthe tumor such as salivary glands remains a significant problem. Salivary glands are remarkably sensitive to radiation, a phenomenon attributed to disruption ofthe plasma membrane on secretory salivary acinar cells and apoptosis.Radiotherapy induced salivary gland dysfunctionresults in hyposalivation (reduction in salivary flow rate), xerostomia (i.e., thesensation of oral dryness), mucositis, oral infections, difficulty withmastication, dysphagia and loss of taste. As a consequence of the adverse effects directlyrelated to salivary gland hypofunction, the quality of life following radiationtherapy for the head and neck cancer patients may severely deteriorate,characterized by restriction of daily activities, a poorer general health,social disabilities and malnutrition. Effective management of dry mouth symptoms may improve nutritionalstatus of patients and reduce the disease burden on these patients as wellthereby enhancing their overall well being.  A new concept & generation of dry mouth care system have beenmarketed as salivary stimulants. These product formulations not only mimic theessential salivary peroxidase system, but also introduce other naturallyoccurring salivary components to help supplement the mouth’s naturalantibacterial and immune mechanism.These are marketed as systemcomprising salivary stimulating gels, antibacterial toothpaste and alcohol freefluoride mouthwash.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • •1.With previous radiotherapy treatment where the field of irradiation encompasses the major and minor salivary glands.
  • •2.With a subjective complaint of dry mouth.
  • •3.With at least 10 remaining natural teeth and taking nutrition orally.
  • •4.Participants should have finished radiotherapy 1 week prior to the study with a radiation dose more than 60Gy, present with skin integrity, have no history of neck dissection level I or any tumor lesion in the salivary glands.
  • •5.Participants should report complaints compatible with xerostomia and hyposalivation, which will be later confirmed by sialometry.

排除标准

  • •1.Patients with performing stimulated salivary flow rate (SSF) above 1mL/min.
  • •2.Patients having severe dysphagia, or under hyposalivation treatment or salivary stimulants.
  • •4.Those receiving a total radiotherapy dose of 50Gy or less.

结局指标

主要结局

Increase in the salivary flow, pH & buffering capacity & decrease in the caries susceptibility

时间窗: Baseline | 1 month | 3 months | 6 months

次要结局

未报告次要终点

研究者

发起方
DrAnam Alam
申办方类型
Other [self]

研究点 (1)

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