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CTRI Number  CTRI/2024/07/070697 [Registered on: 16/07/2024] Trial Registered Prospectively
Last Modified On: 15/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparing patient satisfaction of denture teeth selection using a new method of esthetic strips and a traditional method 
Scientific Title of Study   A Randomized Controlled Trial to Compare Patient Satisfaction Related to Denture Teeth Selection by Using Novel Esthetic Strips and a Conventional Method. 
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 Ravishankar Krishna 
Designation  Professor Department of Prosthodontics 
Affiliation  Faculty of Dental Sciences Ramaiah University of Applied Sciences 
Address  Department of Prosthodontics Faculty of Dental Sciences Ramaiah University of Applied Sciences New BEL Rd Gnanagangothri Campus MSRIT Bengaluru Karnataka

Bangalore
KARNATAKA
560054
India 
Phone  9986930202  
Fax    
Email  docravi76@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ritika Jeenoor 
Designation  Post graduate student 
Affiliation  Faculty of Dental Sciences Ramaiah University of Applied Sciences 
Address  New BEL Rd Gnanagangothri Campus MSRIT Bengaluru Karnataka


KARNATAKA
560054
India 
Phone  9986930202  
Fax    
Email  ritikajeenoor96@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Ritika Jeenoor 
Designation  Post graduate student Department of Prosthodontics 
Affiliation  Faculty of Dental Sciences Ramaiah University of Applied Sciences 
Address  Department of Prosthodontics Faculty of Dental Sciences Ramaiah University of Applied Sciences New BEL Rd Gnanagangothri Campus MSRIT Bengaluru Karnataka


KARNATAKA
560054
India 
Phone  9986930202  
Fax    
Email  ritikajeenoor96@gmail.com  
 
Source of Monetary or Material Support  
Department of Prosthodontics Faculty of Dental Sciences Ramaiah University of Applied Sciences New BEL Rd Gnanagangothri Campus MSRIT Bengaluru - 560054 Karnataka India 
 
Primary Sponsor  
Name  Dr Ritika Jeenoor 
Address  Department of Prosthodontics Faculty of Dental Sciences Ramaiah University of Applied Sciences New BEL Rd Gnanagangothri Campus MSRIT Bengaluru - 560054 Karnataka India 
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 Ritika Jeenoor  Department of Prosthodontics Faculty of Dental Sciences, Ramaiah University of Applied Sciences  Department of Prosthodontics Faculty of Dental Sciences Ramaiah University of Applied Sciences New BEL Rd Gnanagangothri Campus MSRIT Bengaluru - 560054 Karnataka India
Bangalore
KARNATAKA 
9986930202

ritikajeenoor96@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
University Ethics Committee for Human Trials  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  Novel esthetic strips  These strips are made by trimming maxillary anterior acrylic denture teeth to a thickness of 1.5 mm and stuck on 0.05 mm thickness tissue tape. This is then stuck to the labial surface of the maxillary occlusion rim to enable the completely edentulous patients to visualize the final outcome of their complete dentures  
Intervention  Selection of maxillary anterior acrylic teeth for completely edentulous patients for complete dentures  Maxillary anterior acrylic teeth of various sizes will be selected using two methods - a conventional method using inter-alar distance a guide for the selection of acrylic teeth and using a new method by using novel esthetic strips 
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Patients who are completely edentulous and willing for replacement
2. Both male and female patients
3. Patients between the ages of 45 to 80 years
 
 
ExclusionCriteria 
Details  1. Gross asymmetry
2. Patients not willing to participate in the study
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Developing the novel esthetic strip by trimming the maxillary anterior acrylic teeth to a thickness of 1.5 mm   2 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
To select the teeth size for edentulous patients with the help of the novel esthetic strips and by a conventional method
To compare the patient satisfaction related to the size of the artificial teeth when the denture teeth are selected using either of the two methods
 
8-10 months 
 
Target Sample Size   Total Sample Size="62"
Sample Size from India="62" 
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)   27/07/2024 
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="0"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Statistical Analysis Plan

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [ritikajeenoor96@gmail.com].

  6. For how long will this data be available start date provided 10-07-2025 and end date provided 01-08-2024?
    Response - Immediately following publication. No end date.

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

The primary consideration for patients seeking prosthetic treatment with missing anterior teeth is esthetics. The size and form of the maxillary anterior teeth are of importance to both dental and facial aesthetics (Vasantha Kumar et al, 2011). Several methods are available for the selection of anterior teeth. Historically, it started with anthropometric measurements such as the bizygomatic width, inter-alar distance, etc., and later advanced to typal form theory, Berry’s biometric ratio method, Wright’s photometric method, etc. (Chander, 2021). 

In the present day, a variety of shade guides, mold sizes and measurements are provided by the manufacturers to help aid the clinician in selecting the anterior teeth. The patients cannot visualize the final outcome of their dentures using these methods. Digital dentistry helps the patients in viewing the final outcome of their dentures during a digital trial registration. This method is quite expensive and may not be feasible in developing countries (Varghese, 2022). The most common method used is the arbitrary selection of anterior teeth with the help of mold sizes based on the patient’s opinion and clinician’s experience. It is time-consuming to attach the different molds of acrylic teeth on the occlusion rims by trial and error. In a study conducted by LaVere, it was found that the anterior teeth sizes used in dentures were smaller than the natural teeth sizes. (LaVere et al, 1994 and Ceruti et al, 2013).

In a randomized case control clinical trial, a new inexpensive method of anterior teeth selection was evaluated. With the help of adhesive paper teeth (Major Moncalieri) available in all mold sizes and shapes, the patients could visualize the final outcome comparatively better than the arbitrary method. The adhesive plasticized papers of different teeth could be placed together or separately. This allowed customization and is an advantage of this new technique. The disadvantage is the necessity of remounting due to operator error in attaching the adhesive teeth to the rims (Ceruti, 2013). A new technique of using life-size coloured print of teeth molds has been developed. This helps the patients in the visualization of the aesthetics of their final dentures. A major drawback was that the teeth could not be arranged individually and the visibility of the background colour of the denture base beyond the incisal edges of the teeth make it unaesthetic (Varghese, 2022).  There are not many studies evaluating the patients’ satisfaction of the denture esthetics related to the teeth size. In order to overcome the drawbacks of the previous studies, a novel three-dimensional esthetic dental strip was designed to help the patients visualize the final esthetic outcome of their dentures.    

Research Question: Is there any change in the patients’ satisfaction of denture esthetics related to teeth size when the maxillary anterior teeth are selected using novel esthetic strips or the conventional methods?

 

Null Hypothesis: There is no change in the patients’ satisfaction of denture esthetics related to teeth size when the maxillary anterior teeth are selected using novel esthetic strips or the conventional methods.

 

Aim: To compare the patient satisfaction related to teeth size when the denture teeth are selected using the novel esthetic strips or by a conventional method.

 

Objectives:

 

1.      To design and develop novel esthetic strips from the commonly used acrylic denture teeth moulds

2.      To select the teeth size for edentulous patients with the help of the novel esthetic strips and by a conventional method

3.      To compare the patient satisfaction related to the size of the artificial teeth when the denture teeth are selected using either of the two methods

         Sample size determination:

The sample size was estimated using the G power software v.3.1.9.2.

Analysis:     A priori: Compute required sample size

Input:           Tail(s)                                             =   Two

                       Effect size d                                  =   0.7

                       α err prob                                     =   0.05

                       Power (1-β err prob)                 =   0.85

                       Allocation ratio N2/N1             =   1

Output:       Noncentrality parameter δ     =   2.7559028

                       Critical t                                         =   1.6706489

                     Df                                                    =   60

                       Sample size group 1                  =   31

                       Sample size group 2                  =   31

                       Total sample size                       =   62

 

Considering the effective size to be measured (d) at 0.7, power of the study at 85% and the margin of error at 5%, the total sample size needed is 62. The total sample size is divided into two groups. Each group will consist of 31 samples (31x2 = 62 samples).

Methodology for objective 1: The average sizes of the artificial teeth will be determined based on a cross-sectional survey measuring the natural anterior teeth sizes amongst people aged more than 45 years old. The commonly used acrylic maxillary anterior teeth corresponding to the sizes commonly used in the institution will be selected for both the genders. These acrylic teeth are then trimmed to a thin shell measuring 1.5 mm in thickness. The sizes selected based on the survey are ArcyRock size 13,15,18 and 32; and Premadent sizes S1, M2, N2, A26. The novel esthetic strip will be formed by attaching the thin shells of acrylic to a tissue tape with a thickness of 0.05 mm.

Methodology for objective 2: The patients will be randomly divided into two groups. For one group, the novel esthetic strips will be used for teeth selection. These strips are attached to the maxillary occlusion rim during the jaw relations appointment to aid teeth selection. Multiple strips can be tried until the patient and the clinician reach a mutual agreement. For the other group of patients, the anterior maxillary teeth will be slected based on a conventional method. This involves arbitrarily selecting anterior teeth with the help of teeth mold sizes based on the width of the ala of the nose which is equivalent to the inter-canine tip distances (Attokoran et al, 2018 and Pisulkar et al, 2022).  

Methodology for objective 3: A patient satisfaction questionnaire related to the teeth size be designed and based on a five-point Likert scale with points ranging from 0 to 4. The lowest point will indicate the worst satisfaction while the highest point will indicate the best satisfaction (0 – very dissatisfied, 1 – dissatisfied, 2 – neither dissatisfied nor satisfied, 3 – satisfied, 4 – very satisfied) (Anastassiadou et al, 2004 and Ahmed et al, 2019). The questionnaire will be filled by both the groups of patients during jaw relations and after the insertion of the dentures. 

Planned statistical analyses:

Statistical package for social sciences (SPSS) for windows version 21.0 released 2021, Armonk NY, IBM Corp was used to analysis the data. 

Independent sample T test will be used to compare the mean patient satisfaction scores using conventional method and novel esthetic strips after jaw relation and insertion of complete denture. 

Chi square test will be applied to compare the proportions of patient satisfaction scores between using the conventional method and novel esthetic strips after Jaw relation and after insertion of the complete denture.

 

 

 


 
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