| CTRI Number |
CTRI/2021/05/033770 [Registered on: 24/05/2021] Trial Registered Prospectively |
| Last Modified On: |
21/05/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
To compare three gingival retraction system with aluminium chloride astringent. |
|
Scientific Title of Study
|
Comparative evaluation of efficacy of gingival retraction using three different gingival retraction system with aluminium chloride astringent; retraction cord, copper wire reinforced retraction cord and astringent retraction paste: A randomised control study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Hardik Maradiya |
| Designation |
Post Graduate Student |
| Affiliation |
Manubhai Patel Dental College |
| Address |
Department of Prosthodontics Crown and Bridge
Manubhai Patel Dental College
Vishwajyoti Ashram near Vidhyakunj School Muj Mahuda
Vadodara
GUJARAT
390011
India |
| Phone |
9909144991 |
| Fax |
|
| Email |
hardik18is4yall@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr sonal mehta |
| Designation |
PG Guide and Professor |
| Affiliation |
Manubhai Patel Dental College |
| Address |
Department of Prosthodontics Crown and Bridge
Manubhai Patel Dental College
Vishwajyoti Ashram near Vidhyakunj School Muj Mahuda
Vadodara
GUJARAT
390011
India |
| Phone |
9428974820 |
| Fax |
|
| Email |
docsonalmehta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Hardik Maradiya |
| Designation |
Post Graduate Student |
| Affiliation |
Manubhai Patel Dental College |
| Address |
Department of Prosthodontics Crown and Bridge
Manubhai Patel Dental College
Vishwajyoti Ashram near Vidhyakunj School Muj Mahuda
Vadodara
GUJARAT
390011
India |
| Phone |
9909144991 |
| Fax |
|
| Email |
hardik18is4yall@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Prosthodontics Crown and Bridge
Manubhai Patel Dental College
Vishwajyoti Ashram near Vidhyakunj School Muj Mahuda |
|
|
Primary Sponsor
|
| Name |
Hardik Maradiya |
| Address |
A 804 Victoria Palace Panvel Point Mota Varachha Surat |
| 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 |
| Hardik Maradiya |
Manubhai Patel Dental College |
Department of Prosthodontics Crown and Bridge
Vishwajyoti Ashram near Vidhyakunj School Muj Mahuda
Vadodara
GUJARAT |
9909144991
hardik18is4yall@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MAHARAJA KRISHNAKUMARSINHJI BHAVNAGAR UNIVERSITY ETHICS COMMITTEE FOR MDS COURSE AND DENTAL RESEARCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
No systematic disease present |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Astringent retraction paste |
Astringent gingival retraction paste contains
15% aluminium chloride. It is easy and time-saving retraction process and decreases the
risk of bleeding after removal. The extra-fine tip of the capsule fits directly into the sulcus. |
| Intervention |
copper wire reinforced Retraction cord |
It is a Fine Metal Filament reinforced retraction cord and can be Impregnated/ Non-impregnated. When the stay – put cord is shaped, it remains in shape and does not deform. It is a unique combination of softly braided retraction cord and ultra fine copper filaments. |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
| Intervention |
Retraction cord |
Ultrapak cord
is made of 100% cotton, knitted into thousands of tiny loops to form long, interlocking
chains.
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Clinically healthy gingiva and periodontium around the teeth
Properly root canal treated teeth/vital teeth
Maxillary/Mandibular 1st molar
|
|
| ExclusionCriteria |
| Details |
Tipped, tilted or rotated abutment teeth
Patients with gingival recession, high plaque index, bleeding on probing, pernicious oral habits, hormonal imbalance, immunocompromised and debilitating pre-existing systemic conditions.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Clinically acceptable retraction will be achieved. |
2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| astringent retraction paste will have good gingival bleeding control capacity |
2 years |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/06/2021 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Patients for this study will be selected from O.P.D of department of
prosthodontics, at the Manubhai Patel dental college, Vadodara. Patients will be informed about the nature of then investigation;
and written informed consent will be obtained prior to enrolment. After signing the consent form, each subject will undergo a complete
oral examination by the principle investigator. Diagnostic impressions of the upper
and lower arches will be made and the impressions will be poured in type IV
dental stone. After tooth preparation, impression will be made with
gingival retraction and impression will be poured in type IV dental stone. The casts that obtained from the die stone,
will be sectioned perpendicular to the coronal plane at the center of the prepared tooth with the
help of a mechanical saw. These
sectioned casts will be used for measurement under the stereomicroscope. |