| CTRI Number |
CTRI/2019/02/017846 [Registered on: 27/02/2019] Trial Registered Prospectively |
| Last Modified On: |
25/02/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of Outcome of Two Techniques in Treating Receding Gums |
|
Scientific Title of Study
|
Comparative Evaluation of Modified Coronally Advanced Flap and Tunnel Technique in the Treatment of Marginal Tissue Recessions-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 |
Sidrath aijaz |
| Designation |
Post graduate |
| Affiliation |
Kamineni Institute of Dental Sciences |
| Address |
Room no.211,Kamineni Institute of Dental Sciences,Narketpally,Nalgonda
Nalgonda
TELANGANA
508254
India |
| Phone |
9052149918 |
| Fax |
|
| Email |
sidrath.aijaz@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S VIDYA SAGAR |
| Designation |
Proffesor |
| Affiliation |
Kamineni Institute of Dental Sciences |
| Address |
Room no.211,Kamineni Institute of Dental Sciences,Narketpally,Nalgonda
Nalgonda
TELANGANA
508254
India |
| Phone |
9052149918 |
| Fax |
|
| Email |
drsagarperio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sidrath aijaz |
| Designation |
Post graduate |
| Affiliation |
Kamineni Institute of Dental Sciences |
| Address |
Room no.211,Kamineni Institute of Dental Sciences,Narketpally,Nalgonda
Nalgonda
TELANGANA
508254
India |
| Phone |
9052149918 |
| Fax |
|
| Email |
sidrath.aijaz@yahoo.com |
|
|
Source of Monetary or Material Support
|
| kamineni institue of dental sciences,sreepuram,narketpally-508254 |
|
|
Primary Sponsor
|
| Name |
sidrath aijaz |
| Address |
Room no.211,Kamineni Institute of Dental Sciences,Narketpally,
Nalgonda-508254 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| sidrath aijaz |
Room no.211,Kamineni Institute of Dental Sciences,Narketpally,
Nalgonda-508254 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| sidrath aijaz |
Department of Periodontics |
Room no.211,Kamineni Institute of Dental Sciences,Narketpally,
Nalgonda-508254
Nalgonda
TELANGANA |
9052149918
sidrath.aijaz@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Modified coronally advanced flap |
a modification of coronally advanced flap by zucchelli for recession coverage has advantages like absence of vertical releasing incisions,variable thickness & submarginal oblique incisions in interdental area |
| Intervention |
tunneling technique |
an undermining split flap preparation of the buccal tissues for root coverage |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Presence of Miller’s Class I or II maxillary or mandibular marginal tissue recession.
2. Age group is 18-55years.
3. Systemically healthy patients
|
|
| ExclusionCriteria |
| Details |
1. Systemically compromised patients.
2. Patients on medications that may interfere with wound healing.
3. Pregnant women and lactating mother.
4. Smokers.
5. Malposed teeth
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 30 Miller’s Class I or II maxillary or mandibular gingival recession (GR) defects which will be randomly assigned into either group using a simple random sampling method |
baseline,3months,6months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 30 Miller’s Class I or II maxillary or mandibular gingival recession (GR) defects which will be randomly assigned into either group using a simple random sampling method |
baseline,3months,6months |
|
|
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
02/03/2019 |
| 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="3"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Comparative Evaluation of Modified Coronally Advanced Flap and Tunnel Technique in the Treatment of Marginal Tissue Recessions – Fifteen marginal tissue recession defects will be treated by modified coronally advanced flap with a connective tissue graft and Fifteen marginal tissue recession defects will be treated by tunnel technique with a connective tissue graft. |