| CTRI Number |
CTRI/2021/05/033569 [Registered on: 12/05/2021] Trial Registered Prospectively |
| Last Modified On: |
16/12/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To evaluate and compare the gums displacement by application of three different methods. |
|
Scientific Title of Study
|
Comparative evaluation of the amount of gingival displacement produced different retraction systems - An in vivo study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rachana shah |
| Designation |
Pg student |
| Affiliation |
MCODS AND MIT , MANIPAL |
| Address |
Dept of prosthodontics, Crown &Bridge.
Manipal college of dental sciences, manipal
Dept of mechanical and manufacturing engineering, manipal intititute of technology , Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9014460441 |
| Fax |
|
| Email |
rachanashah108@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Aparna I N |
| Designation |
Professor |
| Affiliation |
Thesis guide |
| Address |
Dept of prosthodontics, Crown &Bridge.
Manipal college of dental sciences, manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9845648763 |
| Fax |
|
| Email |
aparna.narayan@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Rachana shah |
| Designation |
Pg student |
| Affiliation |
MCODS AND MIT. Manipal |
| Address |
Dept of prosthodontics, Crown &Bridge.
Manipal college of dental sciences, manipal
Dept. of Mechanical & Manufacturing Engineering,
Manipal Institute of Technology, Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
9014460441 |
| Fax |
|
| Email |
rachanashah108@gmail.com |
|
|
Source of Monetary or Material Support
|
| Manipal college of dental sciences, Manipal |
|
|
Primary Sponsor
|
| Name |
Rachana shah |
| Address |
Dept of prosthodontics, Crown and bridge
Manipal college of dental sciences,Manipal |
| 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 |
| Rachana shah |
Manipal college of dental sciences, manipal |
Room NO 5,Department of prosthodontics, Crown and Bridge.
Manipal of college of dental sciences, Eshwar Nagar, Manipal.
Udupi
KARNATAKA |
9014460441
rachanashah108@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| kusturba medical college and Kasturba hospital institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy individual with no signs of gingival inflammation, no bleeding on probing, no malocclusion, clinically healthy mandibular molar tooth |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
3M ESPE RETRACTION PASTE |
Comparing the amount of gingival displacement produced by the retraction cord , retraction paste and combination of retraction cord and retraction paste by using travelling microscope |
| Intervention |
Retraction Cord #000 |
Placement of the retraction cord, retraction paste and combination of retraction cord and retraction paste in clinically healthy mandibular molar tooth in each patient at 14days apart. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
No signs of gingival inflammation
No signs of malocclusion
No bleeding on probing
Probing depth less than 3
Clinically healthy tooth
Mandibular molar tooth selected |
|
| ExclusionCriteria |
| Details |
Signs of attachment loss and clinical mobility
Presence of exudate
History of smoking
Pregnancy
Systemic illness
History of medications |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluation of amount of gingival displacements produced by different gingival retraction systems. |
Baseline, 2weeks, 4weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Since we are comparing different systems so system with best gingival displacement with minimal time ie combination of both cord and cordless can be used for better outcomes. |
14days after placement of any retraction systems |
|
|
Target Sample Size
|
Total Sample Size="17"
Sample Size from India="17"
Final Enrollment numbers achieved (Total)= "17"
Final Enrollment numbers achieved (India)="17" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
14/05/2021 |
| Date of Study Completion (India) |
18/11/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The aim of the study is to evaluate and compare the amount of gingival displacement produced by cord, cordless and combination of cord and cordless systems. Informed consent taken from every patient. Periodontal health evaluated. All three systems have to be evaluated in each patient in the same order in three consecutive sessions spaced 14days apart. Die sectioning of casts done at buccal groove of mandibular molar tooth of each cast and width measured under travelling microscope as the distance from the tooth to the crest of the gingiva. |