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临床试验/CTRI/2024/10/075569
CTRI/2024/10/075569尚未招募不适用

Effect of three different denture adhesives on retention of maxillary heat cured acrylic denture base- A Clinical study

Dr Swati Hambarde1 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2024年10月31日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
9
试验地点
1
主要终点
To evaluate the retention of maxillary heat cured denture base using Fixodent adhesive, Poligrip adhesive and secure denture adhesive.

研究概览

简要总结

Patient’s informed consent will be taken for checking the retention of denture after explaining the details of the procedure. Nine completely edentulous patients seeking prosthodontic rehabilitation are going to get randomly selected as the test subjects in the age group of 40 – 60 years.

For each patient, primary impression of the upper arch is made using an irreversible hydrocolloid impression material in a suitably sized perforated stock tray and poured in plaster of paris to obtain the primary cast. The cast will be properly outlined and relieved for fabrication of custom impression trays using auto polymerizing acrylic resin.Each custom impression tray with spacers is going to be made for each patient. Each tray will be tried in the mouth and peripheries reduced so that they were 2 to 3 mm short of the tissue reflection.

Using the trays, which has spacer of thickness 0.5 - 1 mm thickness, border molding will be completed by the operator in the sectional border molding method using green stick compound and ZOE impression paste is used to make final impression. Beading and boxing of the impressions will be made and the secondary casts are going to be poured.Denture base will be fabricated on secondary cast, and then wax occlusal rims will be preparedusing modelling wax.Flasking and dewaxing will be carried out and the mold will be packed with conventional heat cure denture base resin.Then the flask will be immersed in water in an acrylizer at room temperature and processed according to manufacturer’s instructions. After curing, denture will be deflasked, trimmed, finished, and polished.Later on, pre-fabricated stainless-steel loops will be attached to all heat cured denture using self-cure acrylic resin to the anterior palatal regionand then placed in a container of water. The completed denture base will be placed into the mouth, checked, and adjusted. A U-shaped loop is fabricated using 19 gauge stainless steel wire. Using the wire to assist in determining the denture’s retention the loop is joined to the first molar and second premolar. On both sides, the wire was positioned equally from the reference point (incisive papilla).

The patient was sitting comfortably in an upright position on an adjustable chair with his forehead firmly resting against the forehead support. The patient will be made to stand straight up with a standard head position where the maxilla is parallel to the ground. The heat-polymerized acrylic maxillary denture will have a digital force gauge attached to the loop, and force will be applied by drawing the gauge downward while it is being held in the operator’s palm.For the purpose of assessing the variation in denture retention, readings will be recorded, and the collected data will be tabulated and statistically analysed.

On 1st appointment the retention of the denture with no adhesive (control) and one test adhesive was measured and then on 2nd appointment, other two dental adhesives were measured.The force was applied by pressing down on the digital force gauge, a spring-loaded device that hooked onto the hook of the heat-polymerized denture while being held in the operator’s palm. The force value that was shown on the force metre screen at the time the denture became loose dictated the retention of the denture. For each denture adhesive, three readings were taken, and an average was determined.The denture was put in a basin with denture cleaning solution after the retention was measured.Each patient’s retention of the denture was clinically assessed by having them execute actions like opening and closing their mouths doing mild lip and cheek movements while opening the mouth wide, moving the mandible side to side, and looking for any loose denture .

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 65.00 Year(s)(—)
性别
All

入选标准

  • 1.Well rounded ridges having firm mucoperiosteum 2.Upper complete denture with no signs of inflammation
  • No flabby tissue covering the edentulous ridge
  • Should have a normal temporomandibular joint function
  • With no history of any allergy to dental materials.

排除标准

  • Patients having flat or deep palatal vaults
  • Torus palatinus, uneven ridges, knife-edge ridges
  • Unhealed extraction sockets
  • Any mechanical undercuts or bony exostosis
  • Poor neuromuscular control.

结局指标

主要结局

To evaluate the retention of maxillary heat cured denture base using Fixodent adhesive, Poligrip adhesive and secure denture adhesive.

时间窗: At base line, Same time

次要结局

  • To evaluate and compare the retention of maxillary heat cured denture base using Fixodent adhesive, Poligrip adhesive and Secure denture adhesive.

研究者

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

Swati Hambarde

KVG Dental College and hospital, Sullia

研究点 (1)

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