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CTRI Number  CTRI/2024/08/072065 [Registered on: 07/08/2024] Trial Registered Prospectively
Last Modified On: 05/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Crossover Trial 
Public Title of Study   Incorporation of palatal rugae and evaluating patients perceptions, with and without rugae on dentures. 
Scientific Title of Study   Comparative evaluation of complete dentures adaptability with and without rugae incorporated 
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 Anne Mary 
Designation  P G student 
Affiliation  KVG dental college and hospital 
Address  Room no-3 Department of Prosthodontics and crown and bridge KVG Dental College and Hospital Kurinjibhag Sullia Dakshina Kannada Karnataka India Pincode 574327

Dakshina Kannada
KARNATAKA
574327
India 
Phone  9611348986  
Fax    
Email  annemary4488@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Deviprasad Nooji 
Designation  Professor 
Affiliation  KVG dental college and hospital 
Address  Room no-3 Department of Prosthodontics and crown and bridge KVG Dental College and Hospital Kurinjibhag 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 no-3 Department of Prosthodontics and crown and bridge KVG Dental College and Hospital Kurinjibhag 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  
NIL 
 
Primary Sponsor  
Name  Dr Anne Mary 
Address  3rd year, Post graduate student, Department of Prosthodontics, KVG dental college, Sullia, Karnataka, India. 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 Anne  KVG dental college  Room no-3 Department of Prosthodontics and crown and bridge KVG Dental College and Hospital Kurinjibhag Sullia Dakshina Kannada Karnataka India Pincode 574327
Dakshina Kannada
KARNATAKA 		 9611348986

annemary4488@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee 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: K068||Other specified disorders of gingiva and edentulous alveolar ridge, (2) ICD-10 Condition: K068||Other specified disorders of gingiva and edentulous alveolar ridge, (3) ICD-10 Condition: K081||Complete loss of teeth,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dentures incorporated with palatal rugae for males and females and check adaptability of dentures  Palatal rugae is incorporated into denture. Dentures are given for 1 month to male and females patients without rugae incorporated and check for adaptability by questionnaire 
Comparator Agent  Dentures incorporated without palatal rugae for males and females and check adaptability of dentures  Palatal rugae is incorporated into denture. Dentures are given for 1 month to male and females patients without rugae incorporated and check for adaptability by questionnaire 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Patient willing to participate and give consent
2.Completely edentulous maxillary arch
3.Patients with firm mucosa all over the denture bearing area
 
 
ExclusionCriteria 
Details  1. Patient not willing to give informed consent
2. Patients with severe undercuts, bony exostosis and tori
3. Patient with any signs of inflammation or ulceration or hyperplasia.
4. Patients with cleft palate
5. Patients with extreme high palatal vault.
6. Patients with poor neuromuscular control.
7. Patient with epilepsy or cardiac pacemakers.
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Adaptability of complete dentures with and without incorporation of rugae using VAS scale  1 month following denture delivery 
 
Secondary Outcome  
Outcome  TimePoints 
Comparison of adaptability of complete dentures with & without incorporation of rugae in males & females after crossover period using VAS scale  Crossover study in male & female after period of 1 month 
 
Target Sample Size   Total Sample Size="24"
Sample Size from India="24" 
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   Phase 2/ Phase 3 
Date of First Enrollment (India)   29/09/2024 
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="0"
Months="3"
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  

24 patients aged between 40 to 70 years will be considered for the treatment. The patients will be randomly divided into 4 groups before treatment.

GROUP A- 6 females with completely edentulous maxillary arch with rugae incorporated in complete dentures

GROUP B- 6 females with completely edentulous maxillary arch without rugae incorporated in complete denture

GROUP C- 6 Males with completely edentulous maxillary arch with rugae incorporated in complete denture

Group D: 6 Males with completely edentulous maxillary arch without rugae incorporated in complete denture

Patients who will give consent to participate will be taken for checking the adaptability of denture through VAS score 24 completely edentulous patients seeking prosthodontic rehabilitation are going to get randomly selected as the test subjects in the age group of 40-70 years. For each patient, primary impression of the upper arch will be made using an irreversible hydrocolloid impression material in a suitably sized perforated stock tray and poured in dental stone to obtain the primary cast. During the denture construction process, a duplicate of the maxillary cast for each participant will be poured in Type III dental stone. To record the rugae area details, addition silicone impression material, will be adapted on the anterior palatal area of the duplicated cast. Thus, a silicone index of the rugae area will be obtained. Auto polymerizing acrylic resin will be then beaded onto it to record the imprints of the rugae. Once auto polymerized, the acrylic resin imprint will be removed and trimmed to the correct size as delignated on the cast. The maxillary denture existing rugae area will be roughened and thinned using an acrylic bur to minimize the increase of palatal base thickness. The acrylic resin rugae will be then adapted carefully and secured to the palatal area of the existing prosthesis with auto polymerizing acrylic resin. The incisive papillae, labial frenum and midline will be used as a guide for proper orientation and adaptation. The palatal area will be then carefully finished and polished to remove any steps or rough borders. 

The complete denture will be processed, retrieved from flask, and carefully finished only to remove excess material from the borders. A crossover study will be done where 3 female and male participants will be sent home with their modified complete dentures. And 3 female participants will be sent home with complete dentures without rugae incorporated. Participants were recalled after one month period for crossover and review appointment and data collection (VAS score) was repeated in the same manner with dentures with and without rugae. In order to remove the palatal rugae from the denture surface, the rugae were gently polished in the laboratory till a smooth polished palate was obtained. During the data collection process at the review appointments, participants will be asked to rate their general satisfaction with different palatal contours on a VAS, they will be asked to rate their satisfaction regarding eating, taste perception, speaking, phonetics, and ease of cleaning.





 



 
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