| CTRI Number |
CTRI/2025/09/094507 [Registered on: 10/09/2025] Trial Registered Prospectively |
| Last Modified On: |
09/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Comparing the two different systems of gingival displacement methods in the participants in two interventions followed by checking the quality of margins in the impression and gingival inflammation caused by the two systems |
|
Scientific Title of Study
|
COMPARATIVE EVALUATION OF TWO DIFFERENT
GINGIVAL RETRACTION SYSTEMS TO CHECK GINGIVAL DISPLACEMENT IN VERTICAL & HORIZONTAL DIRECTIONS, QUALITY OF GINGIVAL MARGINS ON THE IMPRESSION AND GINGIVAL INFLAMMATION-AN INVIVO 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 |
ANKITA KUMARI |
| Designation |
post graduate student |
| Affiliation |
Hazaribag College of Dental Sciences and Hospital |
| Address |
Department of Prosthodontics and crown and Bridge
Hazaribag College of Dental Sciences and Hospital, Demotand, Hazaribag
Department of Prosthodontics and crown and Bridge
Hazaribag College of Dental Sciences and Hospital, Demotand, Hazaribag
Hazaribag
JHARKHAND
825301
India |
| Phone |
8890770828 |
| Fax |
|
| Email |
ankitagupta0595@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Souvir Mohan Pandey |
| Designation |
Professor |
| Affiliation |
Hazaribag College of Dental Sciences and Hospital |
| Address |
Department of Prosthodontics and crown and Bridge
Hazaribag College of Dental Sciences and Hospital, Demotand, Hazaribag
Department of Prosthodontics and crown and Bridge
Hazaribag College of Dental Sciences and Hospital, Demotand, Hazaribag
Hazaribag
JHARKHAND
825301
India |
| Phone |
9634904887 |
| Fax |
|
| Email |
souvir.pandey@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Souvir Mohan Pandey |
| Designation |
Professor |
| Affiliation |
Hazaribag College of Dental Sciences and Hospital |
| Address |
Department of Prosthodontics and crown and Bridge
Hazaribag College of Dental Sciences and Hospital, Demotand, Hazaribag
Department of Prosthodontics and crown and Bridge
Hazaribag College of Dental Sciences and Hospital, Demotand, Hazaribag
Hazaribag
JHARKHAND
825301
India |
| Phone |
9634904887 |
| Fax |
|
| Email |
souvir.pandey@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Hazaribag College of Dental Sciences and Hospital |
| Address |
Hazaribag College of Dental Sciences and Hospital,Demotand, hazaribag-825302 |
| Type of Sponsor |
Other [Private Dental College] |
|
|
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 Souvir Mohan Pandey |
hazraibag college of dental sciences and hospital |
Department of Prosthodontics and Crown and Bridge
hazraibag college of dental sciences and hospital, Demotand, hazaribag
Hazaribag
JHARKHAND |
9634904887
souvir.pandey@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Hazaribag college of Dental Sciences and Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Patients above 18 years with thick gingival biotype, healthy gingiva and periodontium will be included. |
| Patients |
(1) ICD-10 Condition: K05||Gingivitis and periodontal diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
NoCord VPS self-retracting
impression |
A recently introduced cordless technique - NoCord by Centrix, United States of
America, is a one step self retracting polyvinyl impression material which produces
gingival displacement along with making impressions at the same time. |
| Intervention |
SURE-Cord retraction cord |
The chemo-mechanical method using retraction cord soaked
with hemostatic agents or astringents which helps in managing the seepage of fluid
and blood by placing in the gingival sulcus, has been used commonly for the long time. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Patients above 18 years with thick gingival biotype, healthy gingiva and periodontium
will be included. |
|
| ExclusionCriteria |
| Details |
patients with thin gingival biotype, maloccluded teeth, systemic diseases,
pregnant and lactating women and smokers will be strictly excluded from this study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To determine the vertical gingival displacement that will be clinically measured at the
midbuccal region using digital vernier caliper after inducing with each gingival
displacement method.
2. To determine horizontal gingival displacement that will be measured under optical
microscope and image analysis software for each gingival displacement method. |
2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
3. To determine the gingival index before retraction, after retraction & on 7th day of
every interventions.
4. To determine the quality of gingival margins on the impressions by the presence of any
voids or bubbles after every post- gingival displacement, made impression. |
2 weeks |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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)
|
15/10/2025 |
| 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="2"
Months="5"
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
|
| AIM: The aim of the study is to compare the gingival tissue displacement in horizontal and vertical direction, gingival inflammation, and the quality of margins recorded on the impression of two different gingival retraction systems MATERIALS AND METHODS: A clinical trial will be conducted on 34 patients according to inclusion and exclusion criteria for gingival displacement using Sure Cord knitted retraction cord impregnated with aluminum chloride and the NoCord VPS impression system to evaluate the gingival displacement in horizontal and vertical directions, gingival inflammation, and quality of margins recorded on the impression by the three different tissue-displacing materials on the maxillary anterior abutment tooth. Vertical gingival displacement will be measured using a digital vernier caliper. The gingival index will be scored (according to Loe and Silness) before and after the interventions, and the quality of gingival margins on the impression will be evaluated as perfect, acceptable, or unacceptable by the presence of voids and bubbles after every post-gingival displacement impression. The impressions will be poured into die stone, and the cast will be sectioned using a die cutter and will be evaluated under an optical microscope and transferred to the image analyzer software to measure the horizontal displacement. The recorded values will be statistically evaluated. | |