| CTRI Number |
CTRI/2025/09/095367 [Registered on: 24/09/2025] Trial Registered Prospectively |
| Last Modified On: |
23/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparative Evaluation of Occlusion and Disocclusion Time in Fixed Partial Dentures with Milled and 3D Printed PMMA Prostheses: A Randomised Clinical Trial |
|
Scientific Title of Study
|
Comparative Evaluation of Occlusion and Disocclusion Times in Fixed Partial Dentures with Milled and 3D Printed PMMA Prostheses: A Randomized Clinical Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prasanna kumar PS |
| Designation |
Post Graduate Student |
| Affiliation |
Saveetha dental college |
| Address |
Department of Prosthodontics,Clinic 24, Saveetha Dental College, 162, Poonamallee High Rd, Velappanchavadi, Chennai, Tamil Nadu 600077, India
Thiruvallur
TAMIL NADU
600077
India |
| Phone |
9894478590 |
| Fax |
|
| Email |
152309006.sdc@saveetha.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Amrutha shenoy |
| Designation |
senior lecturer |
| Affiliation |
Saveetha dental college |
| Address |
Department of Prosthodontics,Clinic 24, Saveetha Dental College, 162, Poonamallee High Rd, Velappanchavadi, Chennai, Tamil Nadu 600077, India
Thiruvallur
TAMIL NADU
600077
India |
| Phone |
9819122808 |
| Fax |
|
| Email |
amruthashenoyd.sdc@saveetha.com |
|
Details of Contact Person
Public Query
|
| Name |
Prasanna kumar PS |
| Designation |
Post graduate student |
| Affiliation |
Saveetha dental college |
| Address |
Department of Prosthodontics,Clinic 24, Saveetha Dental College, 162, Poonamallee High Rd, Velappanchavadi, Chennai, Tamil Nadu 600077, India
Thiruvallur
TAMIL NADU
600077
India |
| Phone |
9894478590 |
| Fax |
|
| Email |
152309006.sdc@saveetha.com |
|
|
Source of Monetary or Material Support
|
| self spopnsored, conducted in clinic 24,saveetha dental college,162, Poonamallee High Rd,
Velappanchavadi, Chennai, Tamil Nadu 600077, India |
|
|
Primary Sponsor
|
| Name |
prasanna kumar p s |
| Address |
Clinic 24, Saveetha Dental College, 162, Poonamallee High Rd, Velappanchavadi,
Chennai, Tamil Nadu 600077, India |
| Type of Sponsor |
Other [self sponsored] |
|
|
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 Prasanna kumar PS |
Saveetha dental college |
Department of Prosthodontics,Clinic 24, Saveetha Dental College, 162, Poonamallee High Rd,
Velappanchavadi, Chennai, Tamil Nadu 600077, India
Thiruvallur
TAMIL NADU |
09894478590
152309006.sdc@saveetha.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha Dental College - Institutional Human Ethical |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K084||Partial loss of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
milled PMMA prostheses. |
Fabrication of fixed partial dentures using milled PMMA prostheses.
Duratkon:6 months |
| Intervention |
3D printed PMMA |
Fabrication of fixed partial dentures using 3D printed PMMA (Polymethyl methacrylate) prostheses.
duration around:6 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
who is requiring fixed partial dentures, who have good oral hygiene and healthy periodontal status. Participants should have adequate bone support and stable occlusion, with no active oral infections or untreated dental diseases. They must be able to provide informed consent and comply with the study protocol and follow-up visits. |
|
| ExclusionCriteria |
| Details |
who have implant-retained or implant-supported overdentures and removable partial dentures, as well as those with insufficient clinical data. Additionally, individuals with systemic diseases or conditions affecting oral health, active oral infections, untreated periodontal disease, allergies or sensitivities to the prosthetic materials, and those unable to comply with the study protocol or follow-up requirements are excluded. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| typically focuses on the occlusion and disocclusion times, which assess the functional efficiency and timing of bite closure and release with the prostheses. |
0 days,1week,3 week,3 months,6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| prosthesis retention and stability, patient satisfaction regarding aesthetics and comfort, mechanical complications |
0 days,1week,3 week,3 months,6 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 3 |
|
Date of First Enrollment (India)
|
08/10/2025 |
| 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="0"
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
|
This randomized clinical trial aims to compare the occlusion and disocclusion times of fixed partial dentures fabricated using milled versus 3D printed polymethyl methacrylate (PMMA) prostheses. The study will assess the functional performance and efficiency of the two fabrication methods in restoring occlusal function in patients requiring fixed partial dentures. Secondary outcomes include prosthesis retention, stability, patient satisfaction, mechanical complications, and biological responses. Participants will be adult patients with good oral health, suitable for fixed partial denture rehabilitation, and will be randomly assigned to receive either milled or 3D printed PMMA prostheses. Outcomes will be measured at baseline, immediately post-placement, and during follow-ups at 1 week, 3 weeks, 3 months, 6 months to evaluate both short-term adaptation and long-term clinical performance. This study is designed to provide evidence on the comparative effectiveness of these emerging fabrication technologies to guide clinical decision-making in prosthodontics. |