| CTRI Number |
CTRI/2025/06/088568 [Registered on: 10/06/2025] Trial Registered Prospectively |
| Last Modified On: |
10/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
The patient experience and clinical outcome of traditionally and computerized manufactured artificial teeth a comparison -An in-vivo study |
|
Scientific Title of Study
|
Comparative evaluation of patient satisfaction and clinical efficiency with conventionally and digitally fabricated removable partial denture-A non-randomized crossover clinical trial |
| 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 Pranoti Ranit |
| Designation |
PG student |
| Affiliation |
Ranjeet Deshmukh Dental College. |
| Address |
Department of Prosthodontics, Room no. 205 Ranjeet Deshmukh Dental College and Research Center Digdoh hills, Hingna Nagpur.
Nagpur
MAHARASHTRA
440018
India |
| Phone |
08379047887 |
| Fax |
|
| Email |
ranit.pranoti@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Anuj Chandak |
| Designation |
Reader and Guide |
| Affiliation |
Ranjeet Deshmukh Dental College. |
| Address |
Department of Prosthodontics, Room no. 205 Ranjeet Deshmukh Dental College and Research Center Digdoh hills Hingna Nagpur.
Nagpur
MAHARASHTRA
440018
India |
| Phone |
9158192345 |
| Fax |
|
| Email |
dr.anujchandak@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pranoti Ranit |
| Designation |
PG student |
| Affiliation |
Ranjeet Deshmukh Dental College. |
| Address |
Department of Prosthodontics, Room no. 205 Ranjeet Deshmukh Dental College and Research Center Digdoh hills Hingna Nagpur.
Nagpur
MAHARASHTRA
440018
India |
| Phone |
08379047887 |
| Fax |
|
| Email |
ranit.pranoti@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Prosthodontics, Room no 205 Ranjeet Deshmukh Dental College and Research Center, Dighoh Hills, Hingna, Nagpur, Maharashtra, India (440018)
|
|
|
Primary Sponsor
|
| Name |
Dr Pranoti Ranit |
| Address |
Department of Prosthodontics, Room no. 205, Ranjeet Deshmukh Dental College and Research Center, Digdoh Hills, Hingna, Nagpur |
| 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 Pranoti Ranit |
Ranjeet Deshmukh Dental College and Research Center Digdoh hills Hingna Nagpur. |
Department of Prosthodontics Room no. 205
Nagpur
MAHARASHTRA |
08379047887
ranit.pranoti@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ranjeet Deshmukh Dental College and research center ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Removable partial denture |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Kennedys Class I and Class II with sufficient inter-arch space verified by tentative jaw relation in patients with 25-60yrs old .
and patients who are willing to participate in the study. |
|
| ExclusionCriteria |
| Details |
Patients with completely edentulous arch, Patients experiencing problems with mouth opening because of Temporomandibular disorders, patients with congenital or acquired defects in maxilla and mandible, Patients judged ineligible for inclusion criteria by principal investigator or designated contact person because of clinically significant medical or mental health findings. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate and compare patient satisfaction and clinical efficiency in conventionally fabricated removable partial denture and digitally fabricated removable partial denture nil |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
30/06/2025 |
| 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
|
Removable partial dentures remain an essential prosthetic consideration in many conditions of oral rehabilitation, especially when the posterior edentulous space to restored. • The objectives of RPD design have been well established. They include the restoration of function, enhancement of esthetic and, most importantly, the preservation of the remaining teeth and periodontal structures. • The basic concepts of RPD framework design have been widely accepted for over 50 years. • Traditionally, the metal frameworks are produced by the lost-wax casting technique, which involves a series of demanding technical procedures even for experienced dental laboratory technicians. Due to the complexity of conventional RPD production, many possible sources of errors may compromise the framework’s strength, functionality and patient comfort.• Cobalt–chromium is usually the metal alloy used due to its good biocompatibility, appropriate wear and corrosion resistance, high fatigue strength, and low cost. • With continuous developments over several years, present-day technological advancements allow the use of different systems with computer-aided design/computer-aided manufacture (CAD/CAM) technology for the fabrication of removable dentures, including milling and rapid prototyping (RP). • A digital fabrication method has various advantages over conventional methods. In particular, electronic surveying performed in the virtual space, on the basis of the scan data, may determine the path of insertion and removal and control the undercut amount through computation in a more straightforward and accurate way than the conventional surveying. • Satisfaction with RPD depends on individuality of patients, attitude towards RPD, previous RPD experience, encouragement for denture and design and fabrication procedure for RPD. Retention, chewing ability, aesthetics, seem to be the most important factors for RPD acceptance. The purpose of this study is to evaluate and compare the patient satisfaction and clinical efficiency with conventionally and digitally fabricated removable partial denture. Primary Objective: To evaluate and compare patient satisfaction and clinical efficiency in conventionally fabricated removable partial denture and digitally fabricated removable partial denture. Study design: An vivo study. • Study area: Department of prosthodontics. Dental laboratory. • Study duration: Approximately 18 months. • Study expenditure: Approximately Rs. 75,000 – 90,000/- Sample size for clinical trial is 20 considering dropout INCLUSION CRITERIA-• Kennedys Class I and Class II with sufficient inter-arch space verified by tentative jaw relation. • Patient age between 25–60 years. • Patients willingness to participate in the study. EXCLUSION CRITERIA- Patients with completely edentulous arch. • Patients experiencing problems with mouth opening and closing because of temporomandibular disorders. • Patients with congenital or acquired defects in the maxilla and in mandible. • Patients judged ineligible for study inclusion by principal investigator or designated contact person because of clinically significant medical or mental health findings. Procedure- All the patients falling under the inclusion criteria will be given informed consent, and the participants will be allocated to an order of RPD placement. First conventionally fabricated RPD ii given and follow up is done for 3 months then digitally fabricated RPD is given to the same patients and follow up is done after 3 months. and the patient satisfaction is done with the help of questionnaire. Clinical efficiency will be assessed based on the factors of occlusion and phonetics to allow successful use. • Dentures will be independently evaluated by 2 prosthodontist with at least 5 years of experience using a 3 grade scale. • Scale – Poor -0 Fair-1 Good-2
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