COMPARATIVE EVALUATION OF NUTRITIONAL STATUS, ORAL HEALTH-RELATED QUALITY OF LIFE, AND ORAL HYGIENE CONDITION IN PATIENTS BEFORE AND AFTER OBTURATOR PROSTHESIS REHABILITATION FOLLOWING MAXILLECTOMY: A CLINICAL STUDY
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Nutritional status, oral health related quality of life and oral hygiene conditions in patients before and after obturator prosthesis rehabilitation following maxillectomy.
研究概览
简要总结
A total of 30 patients (sample size selected according to the central limit theorem), presenting with a maxillary defect following maxillectomy due to surgery for maxillary cancer, will be selected for the study based on the above-mentioned criteria and provided with an obturator prosthesis as required. All participants will fill out written informed consent forms before recruitment. They will be informed about the study procedure and associated discomfort in the written information sheet. A case history shall be recorded & clinical examination of the patient shall be done.
Pre-prosthetic treatment evaluation
1. Nutritional status of the patient will be evaluated using three nutritional assessment tool
a) patient generated- subjective global assessment(PG-SGA)
b) nutritional risk index (NRI) or Buzby index
c) Malnutrition Universal Screening Tool (MUST).
2. Oral hygiene-related quality of life will be evaluated using the oral health impact profile (OHIP-14).
3. Oral hygiene condition will be calculated using: O’Leary’s Plaque control record
Procedure for fabrication of an obturator
The primary impression of the patient will be made with an irreversible hydrocolloid (alginate). Border moulding using green stick impression compound (DPI, Bombay Burmah Trading Corp Ltd, Mumbai, India) and secondary impression will then be made if necessary. Master cast will be poured with type III gypsum, and maxillomandibular relation recording will be made, if necessary, upon which the obturator will be fabricated using Poly methyl methacrylate (PMMA) resin (DPI, Bombay Burmah Trading Corp Ltd, Mumbai, India) and stainless-steel wire will be used for the fabrication of clasps.
The prosthesis will then be delivered to the patient after proper occlusal adjustment if necessary and proper oral hygiene instructions will be given.
Follow-up evaluation will be made 1 month and 3 months after the treatment.
Post-prosthetic treatment evaluation
1. Oral hygiene-related quality of life will be evaluated using the oral health impact profile (OHIP-14) 1 month after the treatment
2. Oral hygiene condition will be calculated using O’Leary’s Plaque control record of the remaining teeth 1 month after the treatment
3. Nutritional status of the patient will be evaluate 3 months after the treatment
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patient with maxillary defect due to maxillectomy for oral cancer, requiring an obturator prosthesis irrespective of gender.
- •Patients aged 18 years and above 3.Patient with maxillary defect classified under Aramany classification class I-VI and/or soft palate defect.
排除标准
- •1.Patient requiring surgical or delayed surgical obturator not evaluated for the study 2.Completely edentulous patient.
- •3.Patient with an associated systemic disease like cardiovascular disease, or chronic disease related to liver, kidney, or GIT.
- •4.Patient with restrictive mouth opening (15 mm or less).
- •5.Physical & neurological disability that will interfere with the study.
- •6.Patient showing evidence of local recurrence.
结局指标
主要结局
Nutritional status, oral health related quality of life and oral hygiene conditions in patients before and after obturator prosthesis rehabilitation following maxillectomy.
时间窗: Baseline, 1 month and 3 months
次要结局
未报告次要终点
研究者
Dr Priyanka Chhetri
SCB Dental college and Hospital