| CTRI Number |
CTRI/2025/06/088530 [Registered on: 10/06/2025] Trial Registered Prospectively |
| Last Modified On: |
06/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
"A Simple Guide to Front Tooth Impressions: One-Step vs. Two-Step Methods"for anterior Teeth. |
|
Scientific Title of Study
|
Clinical Comparison of Accuracy Between
One-Step Putty Wash and Two-Step Impression Techniques for Fixed Partial Dentures |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Lakshay Kumar |
| Designation |
PG Student |
| Affiliation |
Saveetha Dental College and Hospitals |
| Address |
Clinic 24, 4th floor , Department of Prosthodontics , Saveetha Dental College and Hospitals
Chennai
TAMIL NADU
110026
India |
| Phone |
09582691345 |
| Fax |
|
| Email |
lakshaykumar25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
AMRUTHA SHENOY |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
Saveetha Dental College and Hospitals |
| Address |
Clinic 24, 4th floor , Department of Prosthodontics , Saveetha Dental College and Hospitals
Chennai
TAMIL NADU
600056
India |
| Phone |
9819122808 |
| Fax |
|
| Email |
amruthashenoyd.sdc@saveetha.com |
|
Details of Contact Person
Public Query
|
| Name |
Lakshay Kumar |
| Designation |
PG Student |
| Affiliation |
Saveetha Dental College and Hospitals |
| Address |
Clinic 24, 4th floor , Department of Prosthodontics , Saveetha Dental College and Hospitals
Chennai
TAMIL NADU
110026
India |
| Phone |
09582691345 |
| Fax |
|
| Email |
lakshaykumar25@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saveetha Dental College and hospitals , Poonamalle High Road, Velapanchavdi, Chennai, 600077, Tamil Nadu, India |
|
|
Primary Sponsor
|
| Name |
Saveetha Dental College and hospitals , |
| Address |
Poonamalle High Road, Velapanchavdi, Chennai, 600077, Tamil Nadu, India |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| Lakshay Kumar |
Saveetha dental college and hospitals |
Clinic 24, 4th floor , Department of Prosthodontics , Saveetha Dental College and Hospitals, pooonamalle high road , vellapanchavdi
Chennai
TAMIL NADU |
09582691345
lakshaykumar25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha Dental College -Institutional human ethical committee |
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 |
| Intervention |
single stage poly- vinyl siloxane impression |
Baseline 0 months (immediate post intervention) |
| Comparator Agent |
Two stage polyvinylsiloxane impression |
Baseline 0 months (immediate post intervention) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
The inclusion criteria required patients in good general health, abutment teeth with adequate periodontal support, crown height, and absence of mobility, no requirement for endodontic post and core restorations, and ability to comply with all study visits and procedures |
|
| ExclusionCriteria |
| Details |
Exclusion criteria included known allergies or sensitivity to impression materials, active periodontal or periapical pathology, poor oral hygiene or bleeding on probing, history of radiation therapy in the head and neck region, systemic diseases affecting oral health such as uncontrolled diabetes or autoimmune disorders, parafunctional habits such as bruxism or clenching, and temporomandibular joint disorders or restricted mouth opening. Patients with a history of recent extractions in the anterior segment, tobacco use, substance abuse, psychiatric illness, or cognitive impairment were also excluded from participation. |
|
|
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 |
| accuracy of impression |
base line 0 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| patient comfort |
baseline 0 month
outcome 1 month |
| time taken |
base line 0 months |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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)
|
18/06/2025 |
| 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="1"
Days="1" |
|
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
|
Accurate impressions are crucial for the success of fixed dental prostheses. Among the commonly used techniques with polyvinyl siloxane (PVS) materials are the single-stage and two-stage putty-wash methods. This study compares the accuracy of these two approaches in capturing fine details necessary for precise restorations. |