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临床试验/CTRI/2024/05/067902
CTRI/2024/05/067902尚未招募Phase 3 4

Comparison of two vestibuloplasty techniques to evaluate denture stability in complete denture patients with severely resorbed anterior mandibular ridge: A Prospective Clinical Study

Dr Rohit Kumar Singh1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年6月17日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
20
试验地点
1
主要终点
The pre-prosthetic surgery is expected to enhance the stability of the mandibular complete denture which will improve the quality of life of complete edentulous patients

研究概览

简要总结

a Vestibuloplasty is a surgical procedure designed to deepen the oral vestibule, which is the space between the lips, cheeks, and gums. This procedure is commonly employed in pre-prosthetic surgery to address issues related to the insufficient height of the alveolar ridge, and in periodontology to augment the amount of keratinized gingiva. The alveolar ridge is the bony ridge that contains the tooth sockets in the upper and lower jaws. An adequate height of the alveolar crest is crucial for the stability and retention of removable dentures, especially when implants are not used for support.1-2 Several conditions can contribute to the reduction of vestibular depth, including a prolonged absence of teeth, traumatic injuries to the alveolar ridge, or severe periodontitis (inflammation and infection of the supporting structures of the teeth). When there is a lack of an adequate residual alveolar ridge, it can compromise the successful rehabilitation with removable dentures. Removable dentures are often preferred for economic reasons, making vestibuloplasty an indispensable procedure in cases where the vestibular depth is reduced.3-4 Many vestibular deepening techniques have been described since the beginning of the era of surgery namely, Kazanjian, Godwin, Trauner, Clark, Sulcus deepening, Obwegeser, Howe, Steinhauser, Tortorelli. Vestibuloplasty repositions mucosa, and muscle insertions, and increases the denture flange area in turn stability of the prosthesis. All procedures are associated with varying degrees of success. Disadvantages associated with existing procedures made the clinician rethink modifications so that the modifications can overcome the disadvantages.

·       This clinical study planned to achieve adequate vestibular depth using Clark’s and sulcus deepening vestibuloplasty so that stability of the mandibular denture will be improved.

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
40.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Edentulous patient with a minimum bone height of 15 mm and less than 5 mm of vestibular depth in the mandibular anterior region.
  • Patients with ASA (American Society of Anaesthesiology) class I and II conditions.

排除标准

  • Patients with uncontrolled systemic disorders like hepatic, respiratory, cardiac, endocrine, or metabolic impairment which make the patient unfit for surgical procedure.

结局指标

主要结局

The pre-prosthetic surgery is expected to enhance the stability of the mandibular complete denture which will improve the quality of life of complete edentulous patients

时间窗: Patients will be checked on day zero, day 7, day 15, and in 4th week for satisfactory surgical wound healing. Only after satisfactory healing, we will proceed with the denture fabrication process. The denture will be delivered around 4-6 weeks after soft tissues show at least grade 4(very good) healing.

次要结局

  • Better retention for denture(after 6 months of delivering the dentures)

研究者

发起方
Dr Rohit Kumar Singh
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Prof Dr Nagaraj M

ESIC Dental College & Hospital

研究点 (1)

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