Evaluation of mandibular deviation in post mandibulectomy patients- A cross-sectional study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To measure the mandibular deviation in segmental mandibulectomy patients and its correlation with chewing efficiency and QoL
研究概览
简要总结
Mandibulectomy is a surgical procedure that involves the removal of a portion of the mandible and this procedure is usually performed to treat oral cancer. Following a segmental mandibulectomy patients experience mandibular deviation towards the defect side if the continuity of the defect is not restored. Mandibular deviation can lead to functional in terms of mastication speech and swallowing and aesthetic as well as psychological issues thus adversely impacting the patient quality of life. Post-mandibulectomy rehabilitation involves a multidisciplinary approach which includes surgical reconstruction with bone or reconstruction plate the use of guide bite prosthesis and dental rehabilitation and physical therapy depending on the clinical situation and patients individual needs.
No literature is present describing the amount of mandibular deviation in mandibulectomy patients.
The aim of the proposed research is to analyze the mandibular deviation in segmental mandibulectomy patients and its effect on the masticatory efficiency and Quality of life in head and neck cancer patients.
This is a Cross-sectional observational studythat will enroll the mandibulectomy patients reporting to the dental OPD based on the inclusion and exclusion criteria.
Outcome evaluation would quantify the degree of deviation in millimeters and assess the prevalence and severity of mandibular deviation. The deviations will be compared based on factors like the extent of the defect radiation treatment and prosthesis use. Chewing performance would be evaluated by the mixing ability. The chewing efficiency of study participants will be evaluated and compared between different subgroups based on the mentioned factors. The Quality of life would be evaluated by the EORTC QLQ-C30 and HN35. The outcome would assess the impact of mandibular deviation on the overall quality of life of participants and analyze differences in quality of life scores based on the time elapsed since surgery the extent of the defect radiation treatment and prosthesis use. The outcome would also analyze the effect of guide bite prosthesis usage on mandibular deviation chewing efficiency and quality of life by comparing outcomes between users at different time points.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •18 to 70 year-old patient who has undergone resection of the mandible for Ca gingivobuccal complex (± upper alveolus) reconstructed with the soft tissue flap.
- •The post-surgery duration is at least 3 months or more.
- •Have a total of 6 or more teeth in both arches of the non-resected quadrant.
- •Have a mouth opening of at least 1.5 cm.
排除标准
- •Patients with major intra-oral defects such as total glossectomy or total maxillectomy limiting oral function.
- •Jaw reconstructed with bone or reconstruction plate Non-consenting patients.
结局指标
主要结局
To measure the mandibular deviation in segmental mandibulectomy patients and its correlation with chewing efficiency and QoL
时间窗: single time
次要结局
- To evaluate the mandibular deviation using dental midline, & mediolateral relation of maxillary & mandibular teeth.(Evaluation of extraoral deviation & its correlation with dental deviation & mediolateral relation of maxillary & mandibular teeth.)
研究者
Dr Pankaj Chauhan
Homi Bhabah Cancer Hospital and Research Centre