| 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
|
|
|
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
|
|
|
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
|
|
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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 . | |