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临床试验/CTRI/2024/08/072065
CTRI/2024/08/072065尚未招募2/3 期

Comparative evaluation of complete dentures adaptability with and without rugae incorporated

Dr Anne Mary1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2024年9月29日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
24
试验地点
1
主要终点
Adaptability of complete dentures with and without incorporation of rugae using VAS scale

研究概览

简要总结

24 patients aged between 40 to 70 years will be considered for the treatment. The patients will be randomly divided into 4 groups before treatment.

GROUP A- 6 females with completely edentulous maxillary arch with rugae incorporated in complete dentures

GROUP B- 6 females with completely edentulous maxillary arch without rugae incorporated in complete denture

GROUP C- 6 Males with completely edentulous maxillary arch with rugae incorporated in complete denture

Group D**:** 6 Males with completely edentulous maxillary arch without rugae incorporated in complete denture

Patients who will give consent to participate will be taken for checking the adaptability of denture through VAS score 24 completely edentulous patients seeking prosthodontic rehabilitation are going to get randomly selected as the test subjects in the age group of 40-70 years. For each patient, primary impression of the upper arch will be made using an irreversible hydrocolloid impression material in a suitably sized perforated stock tray and poured in dental stone to obtain the primary cast. During the denture construction process, a duplicate of the maxillary cast for each participant will be poured in Type III dental stone. To record the rugae area details, addition silicone impression material, will be adapted on the anterior palatal area of the duplicated cast. Thus, a silicone index of the rugae area will be obtained. Auto polymerizing acrylic resin will be then beaded onto it to record the imprints of the rugae. Once auto polymerized, the acrylic resin imprint will be removed and trimmed to the correct size as delignated on the cast. The maxillary denture existing rugae area will be roughened and thinned using an acrylic bur to minimize the increase of palatal base thickness. The acrylic resin rugae will be then adapted carefully and secured to the palatal area of the existing prosthesis with auto polymerizing acrylic resin. The incisive papillae, labial frenum and midline will be used as a guide for proper orientation and adaptation. The palatal area will be then carefully finished and polished to remove any steps or rough borders.

The complete denture will be processed, retrieved from flask, and carefully finished only to remove excess material from the borders. A crossover study will be done where 3 female and male participants will be sent home with their modified complete dentures. And 3 female participants will be sent home with complete dentures without rugae incorporated. Participants were recalled after one month period for crossover and review appointment and data collection (VAS score) was repeated in the same manner with dentures with and without rugae. In order to remove the palatal rugae from the denture surface, the rugae were gently polished in the laboratory till a smooth polished palate was obtained. During the data collection process at the review appointments, participants will be asked to rate their general satisfaction with different palatal contours on a VAS, they will be asked to rate their satisfaction regarding eating, taste perception, speaking, phonetics, and ease of cleaning.

研究设计

研究类型
Interventional
分配方式
Other
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

  • 1.Patient willing to participate and give consent 2.Completely edentulous maxillary arch 3.Patients with firm mucosa all over the denture bearing area.

排除标准

  • Patient not willing to give informed consent
  • Patients with severe undercuts, bony exostosis and tori
  • Patient with any signs of inflammation or ulceration or hyperplasia.
  • Patients with cleft palate
  • Patients with extreme high palatal vault.
  • Patient with epilepsy or cardiac pacemakers.

结局指标

主要结局

Adaptability of complete dentures with and without incorporation of rugae using VAS scale

时间窗: 1 month following denture delivery

次要结局

  • Comparison of adaptability of complete dentures with & without incorporation of rugae in males & females after crossover period using VAS scale(Crossover study in male & female after period of 1 month)

研究者

发起方
Dr Anne Mary
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Anne Mary

KVG dental college and hospital

研究点 (1)

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