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临床试验/NCT07246343
NCT07246343已完成不适用

Impact of Retro-molar Pad Demarcation on Complete Denture Wearers' Satisfaction and Quality of Life: a Cross-over, Double-blind Clinical Trial.

Samiha Sartawi1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年2月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
1
主要终点
patient satisfaction

研究概览

简要总结

the retromolar pad is a critical anatomical landmark in the lower edentulous arch marking the posterior end of any removable prosthesis. The significance of using this area to aid the retention of the lower denture is evaluated in this clinical study especially that the lower denture is always inferior in retention compared to the upper denture as a result of reduced denture bearing area.

详细描述

The retromolar pad is a key intraoral anatomical landmark in removable prosthodontics. It comprises of non-keratinized loose alveolar tissue covering glandular tissues and muscle fibers. The denture base should extend to cover the retromolar pad. There are variations in the anatomical shape of the retromolar pad, however, no reports in the literature to record that area on the cast and to measure its effect on the retention of the lower denture.

The retromolar pad is a key intraoral anatomical landmark in removable prosthodontics. The denture base should cover the retromolar pad not only to provide proper peripheral seal but also for stability of the denture by adding another plane to resist movements of the base. Furthermore, it remains a stable landmark even in advanced ridge resorption. It is also considered a crucial landmark to determine the occlusal plane where the later terminates posteriorly in the middle of the upper third of the retromolar pad. The mandibular first molar is usually found at the level corresponding to the anterior two thirds of the retromolar pad area. The pad comprises of non-keratinized loose alveolar tissue covering the glandular tissues, fibers of buccinator muscle, fibers of superior constrictor muscle, fibers of ptergomandibular raphe and the terminal part of the tendon of temporalis muscle. After the molars are lost the bone and surrounding soft tissues remodels, resorbs and blends with retromolar pad. The mylohyoid muscles and the buccinator muscles affixed to nearby bony areas are some of the barriers to the chronic but limited bone resorption of the retromalr pad, following tooth loss, time of edentulism, systemic factors, and denture wear.

There are variations in the anatomical shape (pear, triangular and circular) and size of retromolar pad area both in the same patient and in different patients. It was reported that the denture posterior border should be defined at least more posteriorly than in the 2/3 of the retromolar pad (positioned about 7mm distal to the anterior margin of the retromolar pad) and preferably as much as possible to be extended to the distal end dome of the retromolar pad (about 15mm from the anterior margin of the retromolar pad).

The lower denture is usually less retentive than the upper denture due to the reducced surface area covered. The retromolar pad area defines the posterior end of the denture and helps in the retention and stability of the lower denture, however no reports in the literature to record that area on the cast and to measure its effect on retention. Therefore, this clinical study aims to evaluate the effect of carving the retromolar pad area on the retention of the lower denture.

Therefore this clinical study aims to evaluate the effect of carving the retromolar pad area on the retention of lower denture. 50 edentulous patients with no previous denture history will be recruited. Complete dentures will be constructed for each patient with two sets of mandibular dentures by one prosthodontist. One conventional lower denture and one denture with added rertomolar pad whereby one of the dentures will be delivered and after one month the second denture is delivered. Both dentures will be assessed one month after insertion using validated questionnaires. Clinical assessment of the dentures will be performed by two blind prosthodontists on a visual analogue scale. Data will be analyzed using SPSS software.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
40 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Recent extraction with the last tooth extracted for at least three months ago
  • •No previous denture experience (first time complete denture wearers) in both maxilla and mandible
  • •Ridge classification: Atwood's class III in both maxilla and mandible
  • •No relevant medical conditions or oral pathologies including lesions or ulcers, xerostomia, or tongue tie that could affect the treatment or compliance with treatment
  • •Both genders aged 40-80 years
  • •Participants who signed the consent form

排除标准

  • •denture wearers
  • •any medical or soft tissue problems
  • •not signed the consent form

研究组 & 干预措施

edentolous patients

Experimental

patient satisfaction and quality of life

干预措施: carving of retromolar pad area (RMP) (Procedure)

edentolous patients

Experimental

patient satisfaction and quality of life

干预措施: no carving of the retromolar pad area (RMP) (Procedure)

Prosthodontist evaluation

Experimental

evaluation of mucosal changes and lower denture retention

干预措施: carving of retromolar pad area (RMP) (Procedure)

Prosthodontist evaluation

Experimental

evaluation of mucosal changes and lower denture retention

干预措施: no carving of the retromolar pad area (RMP) (Procedure)

结局指标

主要结局

patient satisfaction

时间窗: Two months

Patient satisfaction after carved and non carved areas in lower denture. After each period, a blinded dentist asked participants to rate their satisfaction on a 100-mm visual analogue scale regarding eating, taste perception, speaking, and phonetics.

patient quality of life

时间窗: Two months

The quality of life of participants after carved and non carved areas in lower denture was assessed. Participants were asked to fill the 20-item oral health impact profile for edentulous patients (OHIP-EDENT) before and after treatment with each experimental lower denture.

次要结局

  • assessment of mucosal response and denture outcomes.(Two months)

研究者

发起方
Samiha Sartawi
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Samiha Sartawi

Principal investigator

University of Jordan

研究点 (1)

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