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CTRI Number  CTRI/2024/10/075569 [Registered on: 21/10/2024] Trial Registered Prospectively
Last Modified On: 20/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Diagnostic 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Checking retention of upper denture base using different adhesives 
Scientific Title of Study   Effect of three different denture adhesives on retention of maxillary heat cured acrylic denture base- A Clinical study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Swati Hambarde 
Designation  P G student 
Affiliation  KVG Dental College and hospital, Sullia 
Address  Room number 3 Department of Prosthodontics and crown and bridge KVG Dental College and Hospital Kurunjibhag Sullia Dakshina Kannada

Dakshina Kannada
KARNATAKA
574327
India 
Phone  7620923587  
Fax    
Email  swatihambarde01@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Suhas Rao K 
Designation  Professor and Head of Department of Prosthodontics and crown and bridge 
Affiliation  KVG Dental College and hospital, Sullia 
Address  Room number 3 Department of Prosthodontics and crown and bridge KVG Dental College and Hospital Kurunjibhag Sullia Dakshina Kannada

Dakshina Kannada
KARNATAKA
574327
India 
Phone  9845321618  
Fax    
Email  drsuhask@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Suhas Rao K 
Designation  Professor and Head of Department of Prosthodontics and crown and bridge 
Affiliation  KVG Dental College and hospital, Sullia 
Address  Room number 3 Department of Prosthodontics and crown and bridge KVG Dental College and Hospital Kurunjibhag Sullia Dakshina Kannada

Dakshina Kannada
KARNATAKA
574327
India 
Phone  9845321618  
Fax    
Email  drsuhask@gmail.com  
 
Source of Monetary or Material Support  
KVG Dental College and Hospital Kurunjibhag Sullia Dakshina Kannada Karnataka India Pincode 574327 
 
Primary Sponsor  
Name  Dr Swati Hambarde 
Address  Room number 3 Department of Prosthodontics and crown and bridge KVG Dental College and Hospital Kurunjibhag Sullia Dakshina Kannada karnataka India Pincode 574327  
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Swati Hambarde  KVG Dental College and Hospital  Room number 3 Department of Prosthodontics and crown and bridge KVG Dental College and Hospital Kurunjibhag Sullia Dakshina Kannada karnataka India Pincode 574327
Dakshina Kannada
KARNATAKA 
7620923587

swatihambarde01@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KVG DENTAL COLLEGE AND HOSPITAL  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K081||Complete loss of teeth,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Retention of maxillary heat cured acrylic denture base with Fixodent adhesive  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 prefabricated stainless steel loop, and force will be applied by drawing the gauge downward while it is being held in the operators palm.For the purpose of assessing the variation in denture retention, readings will be recorded using fixodent adhesive. 
Intervention  Retention of maxillary heat cured acrylic denture base with Poligrip adhesive  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 prefabricated stainless steel loop, and force will be applied by drawing the gauge downward while it is being held in the operators palm.For the purpose of assessing the variation in denture retention, readings will be recorded using Poligrip adhesive.  
Intervention  Retention of maxillary heat cured acrylic denture base with Secure denture adhesive  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 prefabricated stainless steel loop, and force will be applied by drawing the gauge downward while it is being held in the operators palm.For the purpose of assessing the variation in denture retention, readings will be recorded using Secure denture adhesive. 
Comparator Agent  Retention of maxillary heat cured denture base with no adhesive  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 prefabricated stainless steel loop, and force will be applied by drawing the gauge downward while it is being held in the operators palm.For the purpose of assessing the variation in denture retention, readings will be recorded using no adhesive. 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Well rounded ridges having firm mucoperiosteum
2.Upper complete denture with no signs of inflammation
3. No flabby tissue covering the edentulous ridge
4. Should have a normal temporomandibular joint function
5. With no history of any allergy to dental materials
 
 
ExclusionCriteria 
Details  1. Patients having flat or deep palatal vaults
2. Torus palatinus, uneven ridges, knife-edge ridges
3. Unhealed extraction sockets
4. Any mechanical undercuts or bony exostosis
5. Poor neuromuscular control
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate the retention of maxillary heat cured denture base using Fixodent adhesive, Poligrip adhesive and secure denture adhesive.  At base line, Same time 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate and compare the retention of maxillary heat cured denture base using Fixodent adhesive, Poligrip adhesive and Secure denture adhesive.

 
At base line, Same time 
 
Target Sample Size   Total Sample Size="9"
Sample Size from India="9" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   31/10/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

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 .

 
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