| CTRI Number |
CTRI/2018/03/012851 [Registered on: 26/03/2018] Trial Registered Prospectively |
| Last Modified On: |
23/03/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A comparative analysis to study the effect of modified coronally advanced tunnel technique in treating gum disease |
|
Scientific Title of Study
|
Modified Coronally Advanced Tunnel Technique in the Treatment of Multiple Gingival Recessions associated With and Without Non Carious Cervical Lesions – A Randomized Controlled Clinical Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr P KAUSALYA DEVI |
| Designation |
postgraduate student |
| Affiliation |
Vishnu Dental College |
| Address |
Department Of Periodontics,
Block II Room No 7
Vishnu Dental College
Bhimavaram
West Godavari District,
Postgraduate student
Department Of Periodontics,
Block II Room No 7
Vishnu Dental College
Bhimavaram
West Godavari District,
West Godavari
ANDHRA PRADESH
534 202
India |
| Phone |
9505082772 |
| Fax |
|
| Email |
kausineeru@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr P KAUSALYA DEVI |
| Designation |
postgraduate student |
| Affiliation |
Vishnu Dental College |
| Address |
Department Of Periodontics,
Block II Room No 7
Vishnu Dental College
Bhimavaram
West Godavari District,
Postgraduate student
Department Of Periodontics,
Block II Room No 7
Vishnu Dental College
Bhimavaram
West Godavari District,
West Godavari
ANDHRA PRADESH
534 202
India |
| Phone |
9505082772 |
| Fax |
|
| Email |
kausineeru@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrKSuneetha |
| Designation |
Professor |
| Affiliation |
Vishnu Dental College |
| Address |
Department Of Periodontics
Block II Room No 7
Vishnu Dental College
Bhimavaram
Department Of Periodontics
Block II Room No 7
Vishnu Dental College
Bhimavaram
West Godavari
ANDHRA PRADESH
534 202
India |
| Phone |
8919554676 |
| Fax |
|
| Email |
konerusuneetha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vishnu dental college, Bhimavaram |
|
|
Primary Sponsor
|
| Name |
P Kausalya Devi |
| Address |
Department of Periodontics And Implantology
Block II
Room 7
Vishnu Dental College
Bhimavaram
West Godavari dt |
| 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 |
| P Kausalya Devi |
Vishnu Dental College |
Department of Periodontics & Implantology,Block II,Room no. 7, vishnu dental college, Bhimavaram
West Godavari
ANDHRA PRADESH |
9505082772
kausineeru@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee VDC/IEC/2017/08 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Gingival Recession, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Modified Coronally Advanced Tunnel Technique for multiple gingival recessions |
Modified Coronally Advanced Tunnel Technique with cervical abrasions in treatment of multiple gingival recessions |
| Intervention |
Modified Coronally Advanced Tunnel Technique In treatment of gingival recessions |
Modified Coronally Advanced Tunnel Technique In Multiple Gingival Recessions Without Cervical abrasions |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1)Systemically Healthy
2)Minimum of two or more Millers class I and Class II recessions
3)Non carious cervical lesions
4)Absence of clinical signs of active periodontal disease
|
|
| ExclusionCriteria |
| Details |
1) Active gingival and periodontal disease.
2) Any systemic conditions that would interfere with healing.
3) Smokers.
4) Pregnant or lactating women
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Amount of root coverage in terms of width and depth. |
Bseline, 6th month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Increase in the width of keratinized gingiva.
Clinical attachment level.
|
Baseline, 6th month |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
01/05/2018 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The
study is randomized, parallel arm single centered trail comparing the root
coverage using modified coronally advanced tunnel technique with and without
cervical abrasions and this will be conducted in one Centre in India and the
primary outcome is the amount of root coverage obtained and secondary outcome
is Increase in the width of keratinized gingiva,
Clinical attachment level, Patient satisfaction analysis and
it is reevaluated at 6 months. |