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CTRI Number  CTRI/2024/07/070967 [Registered on: 22/07/2024] Trial Registered Prospectively
Last Modified On: 19/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Other 
Public Title of Study   Checking the fit of upper complete denture bases using different methods 
Scientific Title of Study   Retention of maxillary complete denture bases achieved through posterior palatal seal registrations with conventional and functional swallow methods using two different border moulding materials - An In-vivo 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  Dr Surabhi S 
Designation  PG student 
Affiliation  KVG Dental College and Hospital 
Address  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
574327
India 
Phone  8310773947  
Fax    
Email  ssurabhi2000@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Deviprasad Nooji 
Designation  Professor 
Affiliation  KVG Dental College and Hospital 
Address  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
574327
India 
Phone  9448688673  
Fax    
Email  devinooji@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Deviprasad Nooji 
Designation  Professor 
Affiliation  KVG Dental College and Hospital 
Address  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
574327
India 
Phone  9448688673  
Fax    
Email  devinooji@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 Surabhi S 
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 Surabhi S  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 
8310773947

ssurabhi2000@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 
Comparator Agent  Border moulding made using conventional method and heavy body impression material.  Conventional method of border moulding will be performed using heavy body polyvinyl siloxane and final impression using light body polyvinyl siloxane impression material. obtained master cast will be scraped in the posterior palatal seal area. The duration of the procedure will be 30 minutes. The quantity of the material depends on the arch size. 
Comparator Agent  Border moulding using conventional method and green stick impression compound   Conventional method of border moulding will be performed using green stick impression compound and final impression using zinc oxide eugenol impression material. obtained master cast will be scraped in the posterior palatal seal area. The duration of the procedure will be 30 minutes. The quantity of the material depends on the arch size. 
Intervention  Border moulding using functional swallow method and green stick impression compound.  In functional swallow method, patients inherent swallowing force is used to record the posterior palatal seal area.The material used in this method is green stick impression compound which is applied over the posterior palatal seal area and functional swallow method will be performed. final impression will be made with zinc oxide eugenol impression material. The duration of the procedure will be 20 minutes. The quantity of the material depends on the arch size. 
Intervention  Border moulding using functional swallow method and heavy body impression material.  In functional swallow method, patients inherent swallowing force is used to record the posterior palatal seal area. The material used in this method is heavy body polyvinyl siloxane impression material which is applied over the posterior palatal seal area and functional swallow method will be performed. final impression will be made with light body polyvinyl siloxane impression material. The duration of the procedure will be 20 minutes. The quantity of the material depends on the arch size. 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Patients with completely edentulous maxilla.
2. Patient willing to give informed consent.
3. Patients between 40-70 years of age.
4. Patients with class I & II residual alveolar ridge in maxilla (according to ACP classification)
5.Patients with firm mucosa all over the denture bearing area without any signs of inflammation or ulceration or hyperplasia.
 
 
ExclusionCriteria 
Details  1.Patients with severe undercuts, bony exostosis and tori.
2.Patients with extreme high palatal vault.
3.Patients with resorbed residual ridge.
4.Patients with poor neuromuscular control.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate and compare the retention of complete denture bases with posterior palatal seal registrations with conventional and functional swallow methods using heavy bodied polyvinyl siloxane impression material.
 
At baseline , 7days 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate & compare the retention of complete denture bases fabricated with posterior palatal seal registrations made using low fusing impression compound & heavy bodied polyvinyl siloxane impression material.  At base line , 7 days 
To evaluate & compare the retention of complete denture bases with posterior palatal seal registrations with conventional & functional swallow methods using low fusing impression compound  At base line ,7 days 
 
Target Sample Size   Total Sample Size="11"
Sample Size from India="11" 
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)   06/01/2025 
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  

 

  The commonly used treatment modality to rehabilitate the completely edentulous patient is tissue supported complete denture. The complete denture success depends on the retention, as it is one of the important objectives. The retention is influenced by various anatomical, physiological, physical, mechanical, and muscular factors. Retention of maxillary denture depends on incorporation of posterior palatal seal. Posterior palatal seal area is the soft tissue area between the movable and non-movable tissues of the soft palate and anteriorly by the junction of the hard and soft palates on which pressure within physiologic limits can be placed to aid in the retention. The additional rationale behind recording posterior palatal seal are to prevent entrapment of food underneath denture, to compensates for the polymerization shrinkage and to reduce gagging. Border moulding is shaping of impression material by functional or manual manipulation of the soft tissue along the border areas of an impression tray to record the contour and size of the vestibule. There are three approaches in recording posterior palatal seal, which includes Functional, Semi functional and Empirical technique. The functional method includes Fluid wax technique. In semi functional, low fusing impression compound is used for border moulding. The empirical techniques includes conventional (Winkler), Boucher’s, Bernard Levin’s, Swenson’s, Pound’s, Silverman’s, Hardy and Kapur method. In conventional method described by Winkler, a T burnisher is used to locate the hamular notch, followed by identifying anterior and posterior vibrating line and marked using indelible pencil. Anterior vibrating line is identified by performing Valsalva maneuver or by saying “ah” with short vigorous bursts. Posterior vibrating line is identified by saying “ah” in short but normal, unexaggerated fashion. Resin denture base is placed in the mouth to transfer all the marking into the master cast. Scraping of the master cast is done using a Kingsley scraper. Median palatine raphae region is scraped to a depth of 0.5-1 mm and area between middle to hamular notch in its deepest point which is one third distance anterior to posterior vibrating line is scraped 1-1.5 mm depth which should merges with the palatal tissues in all direction. The non-scraping Functional swallow method is used wherein inherent swallowing force of the tongue is used to place the soft palate in passive position (ie) downward and forward when head is flexed forward. The dorsum of the tongue will have intimate contact with tray carrying impression material when the patient swallows. Patient is trained to flex the head forward such that the chin is close to or nearly touching the chest and instructed to position the tongue against the palate during swallowing. When the head is bent forward there is 45° angle created between Frankfort plane and horizontal plane. Low fusing impression compound is commonly used material for sectional border moulding. Heavy bodied polyvinyl siloxane impression material with single step technique is used with advantage of excellent manipulative consistency, adequate flow, dimensional stability and adequate working time. Conventionally, functional border moulding is done followed by scraping of the master cast. Despite having good retention, this has disadvantage of over compression of posterior palatal seal tissues. To overcome this disadvantage, functional swallow method is used were patient’s inherent swallowing force is used to displace the soft palate functionally when the head is flexed forward and scraping of the master cast is avoided. In this study, border mouldings will be done with conventional scraping and functional swallow method using low fusing impression compound and heavy bodied polyvinyl siloxane elastomeric material. zinc oxide eugenol and light body polyvinyl siloxane will be used as final impression materials. Hence, this study is done to compare the maxillary denture bases retention fabricated with posterior palatal seal registrations with different border moulding methods and using two different materials.

 
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