| CTRI Number |
CTRI/2025/06/089767 [Registered on: 27/06/2025] Trial Registered Prospectively |
| Last Modified On: |
26/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing the various gingiva displacement methods for better dental dental scans |
|
Scientific Title of Study
|
Efficacy of conventional retraction cord and retraction cordless system on using intra oral digital impression – an interventional study |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sarmila S. |
| Designation |
Postgraduate Student |
| Affiliation |
Mar Baselios Dental College |
| Address |
Mar Baselios Dental College
Thankalam P.O.
Kothamangalam
Ernakulam
KERALA
686691
India |
| Phone |
7594065106 |
| Fax |
|
| Email |
sarmeelah999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Byju Paul Kurian |
| Designation |
HOD & professor |
| Affiliation |
Mar Baselios dental college |
| Address |
Mar Baselios Dental college
Thankalam P.O.
Kothamangalam
Ernakulam
KERALA
686691
India |
| Phone |
9447049455 |
| Fax |
|
| Email |
byjupaulkurian@mbdc.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Sarmila |
| Designation |
postgraduate student |
| Affiliation |
Mar Baselios dental college |
| Address |
Dept of Prosthodontics
Mar baselios dental college
Thankalam p.o.
Kothamangalam
Ernakulam
KERALA
686691
India |
| Phone |
7594065106 |
| Fax |
|
| Email |
sarmeelah999@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mar Baselios Dental College
Thankalam P.O.
Kothamangalam
Ernakulam
kerala
India
686691 |
|
|
Primary Sponsor
|
| Name |
Sarmila S |
| Address |
Mar Baselios Dental College
Thankalam P.O.
Kothamangalam
Ernakulam
Kerala
India
686691 |
| 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 |
| Sarmila |
Mar Baselios dental college |
first Post Graduate student
Dept of Prosthodontics
Thankalam p.o.
Kothamangalam
Ernakulam
KERALA |
7594065106
sarmeelah999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC-MBDC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
participants between age 20-40 years of age willing to place crowns preferably PFM crowns |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
3M retraction ; 3M ESPE |
The paste to be applied in adequate quantity without exerting any pressure by inserting the end of the capsule tip into the sulcus in a single direction. The material to be left in place for two minutes and then removed using an air water syringe.
Time required i 2 minutes |
| Intervention |
Retraction Cord (Sure endo; Sure Cord Plus ) |
The single cord technique will be utilized. The required length of the retraction cord to be positioned, starting from the mesio-buccal interproximal area to the disto-buccal interproximal area. The retraction cord will be kept in the sulcus for five minutes and removed using a fine tweezer.
Time required is 5mins |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Participants in need of PFM crowns wih good oral hygiene and no clinical attachment loss and no bleeding on probing. |
|
| ExclusionCriteria |
| Details |
Participants with active periodontal disease and history of systemic disease ,
pregnancy or lactating women , history of bruxism or parafunctional habits and has large restoration or prostheses interfering the retraction
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Cordless systems may offer superior patient comfort and reduced trauma.Retraction cord may provide better initial displacement but lead to greater tissue rebound.
|
At baseline and post retraction. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
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 4 |
|
Date of First Enrollment (India)
|
25/07/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 study is aimed to evaluate and compare the efficacy of cordless
retraction systems (retraction pastes) and conventional retraction cords in
achieving gingival displacement and their impact on the accuracy of
intraoral digital impressions for fixed prostheses. The study
is to be conducted with 30 sample and are divided into 2
groups were subjected to single crown
preferably. Clinical parameter such as gingival sulcus width is measured at
baseline and post retraction. The impressions
are made using intra oral scanning ( DENTSPLY PRIMESCAN ).The accuracy of the
fit of the crown is analysed with the help of the stereomicroscope ( Magnus MSZ-TR RELEV
) |