| CTRI Number |
CTRI/2014/03/004488 [Registered on: 20/03/2014] Trial Registered Retrospectively |
| Last Modified On: |
13/03/2014 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of efficacy of two surgical techniques used for treatment of receding gums. |
|
Scientific Title of Study
|
Coronally advanced flap with a periosteal pedicle graft (PPG) VS sub epithelial connective tissue graft for root coverage procedures: a comparative analysis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Gazal Gupta |
| Designation |
Post Graduate student |
| Affiliation |
Manipal College of Dental Sciences |
| Address |
Room No. A-216,
Sonia Hostel,
Manipal
Near Udupi
Karnataka
Dept. of Periodontology,
Manipal College of dental sciences,
Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
9902354469 |
| Fax |
|
| Email |
gazal.simplyme@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Betsy Thomas |
| Designation |
Head of department, |
| Affiliation |
Manipal College of Dental Sciences |
| Address |
Dept. of Periodontology, Manipal college of dental sciences, manipal, Udupi, Karnataka- 576104
Dept. of Periodontology,
Manipal College of dental sciences,
Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
09448911388 |
| Fax |
|
| Email |
betsythomas99@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gazal Gupta |
| Designation |
Post Graduate student |
| Affiliation |
Manipal College of Dental Sciences |
| Address |
Room No. A-216,
Sonia Hostel,
Manipal
Near Udupi
Karnataka
Dept. of Periodontology,
Manipal College of dental sciences,
Manipal.
KARNATAKA
576104
India |
| Phone |
9902354469 |
| Fax |
|
| Email |
gazal.simplyme@gmail.com |
|
|
Source of Monetary or Material Support
|
| Manipal college of dental sciences, Manipal |
|
|
Primary Sponsor
|
| Name |
Manipal college of dental sciences |
| Address |
Manipal college of dental sciences, Manipal, Udupi, Karnataka-576104 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Manipal College of dental sciences manipal |
Manipal,
Karnataka |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Gazal Gupta |
Dental OPD, Dept of Periodontology |
Dept of Periodontology.
Manipal College of Dental Sciences,
Manipal
Udupi
KARNATAKA |
9902354469
gazal.simplyme@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba hospital, manipal institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Patients with gingival recession complaining of hypersenstivity |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1)Periosteal pedicle graft technique |
Inversion of periosteum for recession coverage on canines and pre molars |
| Comparator Agent |
Connective tissue graft with coronally positioned flap surgical technique |
Harvesting a connective tissue graft from the palate. Placement of the graft at the site of recession . |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients with Miller class I gingival recession on canines and pre molar on the maxilla.
2) Normal alignment of tooth in arch
3) Patients who can maintain good oral hygiene |
|
| ExclusionCriteria |
| Details |
1) Presence of root caries
2) Smokers and tobacco chewers
3) Systemically compromised
4) History of previous periodontal surgery |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| amount of recession coverage, probing depth, attachment level. keratinized tissue height and width of attached gingiva |
The outcome will be estimated at 3 months and 6 months following the procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Post operative discomfort using visual analogue scale |
At 2 weeks and one month |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
21/07/2012 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The aim of this randomized controlled clinical trial was to evaluate the efficacy of the periosteal pedicle graft technique and the connective tissue graft with coronally advanced flap technique, in the treatment of isolated gingival recession defects in the maxillary canine and pre molar area. This is not only in terms of root coverage but also in terms of patient satisfaction |