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CTRI Number  CTRI/2021/04/032679 [Registered on: 08/04/2021] Trial Registered Prospectively
Last Modified On: 16/05/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Crossover Trial 
Public Title of Study   To check fit of upper denture and its effect on palatal tissue using two methods to establish seal in completely edentulous patients 
Scientific Title of Study   Comparative Evaluation of effect of Two Methods of establishing Posterior Palatal Seal in Maxillary Complete Denture on the Retention and Post-Palatal Tissue Changes After Denture Insertion: A Randomised Clinical Study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Riddhi Lalan 
Designation  PG student 
Affiliation  K M Shah Dental College 
Address  Department of Prosthodontics and Crown And Bridge
K. M. Shah Dental College Sumandeep university Waghodiya 391760
Vadodara
GUJARAT
391760
India 
Phone  9099230227  
Fax    
Email  riddhi.lln27@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rajesh Sethuraman 
Designation  HOD and Guide 
Affiliation  K. M. Shah Dental College 
Address  Department of Prosthodontics and Crown And Bridge
K. M. Shah Dental College Sumandeep university Waghodiya 391760
Vadodara
GUJARAT
391760
India 
Phone  9725038434  
Fax    
Email  rajeshsethu77academics@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Riddhi Lalan 
Designation  PG student 
Affiliation  K. M. Shah Dental College 
Address  Department of Prosthodontics and Crown And Bridge
K. M. Shah Dental College Sumandeep university Waghodiya 391760
Vadodara
GUJARAT
391760
India 
Phone  9099230227  
Fax    
Email  riddhi.lln27@gmail.com  
 
Source of Monetary or Material Support  
K M Shah Dental College and Hospital 
 
Primary Sponsor  
Name  Dr Riddhi Lalan 
Address  Department of Prosthodontics and Crown and Bridge K.M. Shah Dental College Sumandeep University Waghodiya 391760 
Type of Sponsor  Other [Self Sponsored] 
 
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 Riddhi Lalan  K M Shah Dental College  Department of Prosthodontics and Crown and Brodge K M Shah Dental College Sumandeep Vidhyapeeth Waghodiya 391760
Vadodara
GUJARAT 
9099230227

riddhi.lln27@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sumandeep Vidhyapeeth Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K069||Disorder of gingiva and edentulousalveolar ridge, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Compograph aided PPS Technique  The novel device fabricated shall be used to record tissue compressibility, thereby recording PPSA . The duration of this treatment shall be 15 days with 5 appointments in total 
Comparator Agent  Conventional Technique  Low fusing impression compound shall be used to record the PPSA. The duration of this treatment shall be simultaneously done in 15 days with intervention group in 6 appointments 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Completely edentulous participants requiring removable complete dentures

Patients with Type A Maxillary residual ridge morphology and Class I Complete
edentulism based on the American College of Prosthodontists (ACP)
classification

Absence of any systemic disease that produce oral manifestations
 
 
ExclusionCriteria 
Details  Patients with implants or overdenture abutments in upper arch.

Patients with maxillary edentulous ridges with no anterior and/or posterior
undercuts

Patients with excessive gag reflex.

Patients with reduced salivary flow or having xerostomia

Patients with known allergy to denture base material

Presence of physical or psychological ailment that precludes recall visits like
physically handicap

Patients who have V shaped palatal vault

Patients having any surgical or congenital maxillary defects

Patients who are not willing to sign the consent form 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Clinical retention  On day of denture insertion and 7th day 
 
Secondary Outcome  
Outcome  TimePoints 
Clinical evaluation of soft tissue in palatal area  On day of denture insertion and 7th day 
 
Target Sample Size   Total Sample Size="17"
Sample Size from India="17" 
Final Enrollment numbers achieved (Total)= "17"
Final Enrollment numbers achieved (India)="17" 
Phase of Trial   N/A 
Date of First Enrollment (India)   05/05/2021 
Date of Study Completion (India) 27/01/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response (Others) -  Proposals should be directed to riddhi.lln27@gmail.com to gain access, data requestors will need to sign a data access agreement.

  6. For how long will this data be available start date provided 03-01-2025 and end date provided 03-01-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Complete denture prosthodontic treatment is an integral aspect of the dentistry as the quality of life is compromised due to complete tooth loss. Patient’s desires are considered as prime element in fabrication of prosthesis for giving a successful treatment. The patient’s satisfaction or perception has always been a key objective in any prosthodontic treatment.

 

The key in fabricating a good set of complete denture greatly depends on achieving objectives of preservation, stability, support, retention, aesthetics and comfort. Retention, thus, plays a very important role in complete denture.

 

Establishing proper posterior palatal seal commands a definite clinical procedural protocol if one is to create an optimally retentive complete maxillary prosthesis. In this study two methods of establishing the PPS will be followed. One, the conventional method wherein the PPS will be recorded using low fusing green stick compound and other wherein a novel device named “compograph” aided technique shall be used where the the compressibility of tissue is recorded to define its resiliency. Being an indigenously developed instrument and technique, there exists a need to use the instrument to establish the PPS seal and compare both retention and clinical soft tissue changes with the conventional semi functional method. Hence a need to conduct the study was felt necessary with following objectives.

 

1.To evaluate the retention of maxillary complete dentures fabricated using the conventional semi functional technique and Compograph aided Posterior palatal seal using dynamometer retention test

2. To evaluate the clinical retention evaluation of maxillary complete dentures fabricated using the conventional semi functional technique and Compograph aided Posterior palatal seal using functional tests at baseline and after seven days.

3. To evaluate the clinical soft tissue changes seen on Posterior palatal seal area after denture insertion at baseline and after observational period of 7 days for both the groups.

4. To compare the dynamometer retention readings and clinical retention test evaluations of maxillary complete dentures fabricated using the conventional semi functional technique and Compograph aided Posterior palatal seal technique within and between the groups.

5. To compare the clinical changes of soft tissues under maxillary complete dentures fabricated using the conventional semi functional technique and Compograph aided Posterior palatal seal technique within and between the groups.

 

A sample size of 17 patients was calculated for whom two sets for dentures shall be fabricated. Patients who report to Department of Prosthodontics and Crown & bridge, K. M. Shah Dental College & hospital, Vadodara, and seek replacement of all missing teeth with complete denture prosthesis will be screened for inclusion and exclusion criteria of the study. All the patients who fit into the inclusion and exclusion criteria will be included after they sign a written informed consent form  available in three local languages (English, Hindi and Guajarati). All the required information about the study shall be clearly stated to the patients through the patient information sheet (English, hindi and gujarati).

 

Two maxillary dentures shall be fabricated for every patient. However, the denture to be inserted first shall be decided on the basis of a randomised sequence using a computer generated randomization technique. Based upon random allocation, the patients would be given either of the two dentures. Denture insertion procedure shall be done as per routine and evaluated for stability, phonetics, aesthetics and occlusion.

 

The Dynamometer Retention test, Clinical functional retention tests and clinical evaluation of soft tissue in the PPS area shall be performed by a blinded evaluator on the day of denture insertion and 7 days after the denture delivery

 

On the seventh day after the first denture insertion, the first denture shall be taken away from the participant. The participant shall now be placed on a washout period of no denture wear for seven days. After this, the second denture as per the allocation sequence shall be inserted and the steps as followed for testing and follow up evaluations shall be conducted by the same blinded evaluator after seven days of use of second denture.

The data of retention tests and clinical soft tissue changes shall be entered in the Proforma sheet


 The ethical and feasibility issues shall be addressed.

 

This study will help us to evaluate which of the two methods of establishing Posterior palatal seal is more beneficial with respect to retention and post palatal soft tissue health. The same technique shall be recommended in further clinical practice. 
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