| 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
|
|
|
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
|
|
|
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. |