| CTRI Number |
CTRI/2011/10/002071 [Registered on: 17/10/2011] Trial Registered Prospectively |
| Last Modified On: |
15/10/2011 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
a clinical trial to compare the results obtained between two surgical procedures used for regenerating lost gum |
|
Scientific Title of Study
|
comparative evaluation of coronally advanced flap with platelet rich fibrin versus sub-epithelial connective tissue graft in the treatment of gingival recession with Quasi experimental design |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anoop S |
| Designation |
PG student |
| Affiliation |
|
| Address |
Post Graduate Student
Department of Periodontics
P M S College of Dental Science and Research
golden hills
vattapara
trivandrum
Thiruvananthapuram
KERALA
695028
India |
| Phone |
8891264263 |
| Fax |
|
| Email |
anoopperio@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Seba Abraham |
| Designation |
Professor & HOD |
| Affiliation |
|
| Address |
Department of Periodontics
P M S College of Dental Science and Research
golden hills
vattapara
trivandrum
Thiruvananthapuram
KERALA
695028
India |
| Phone |
04712439631 |
| Fax |
|
| Email |
sebapazhoor@pazhoor.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anoop S |
| Designation |
PG student |
| Affiliation |
|
| Address |
Department of Periodontics
P M S College of Dental Science and Research
golden hills
vattapara
trivandrum
KERALA
695028
India |
| Phone |
8891264263 |
| Fax |
|
| Email |
anoopperio@gmail.com |
|
|
Source of Monetary or Material Support
|
| department of periodontics
P M S College of Dental science and Research
golden hills
vattapara
trivandrum |
|
|
Primary Sponsor
|
| Name |
Dr Anoop s |
| Address |
PG student
department of periodontics
P M S College of Dental science and Research
golden hills
vattapara
trivandrum |
| Type of Sponsor |
Other [] |
|
|
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 |
| Dr Anoop S |
department of periodontics P M S College of Dental science and Research |
department of periodontics
room no 8
first floor
P M S College of Dental science and Research
golden hills
vattapara
trivandrum
Thiruvananthapuram
KERALA |
8891264263
anoopperio@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
need a dental surgery to regenerate lost gums, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Coronally advanced flap with Platelet rich fibrin |
With two vertical incisions, delineate the flap. These incisions should go beyond the mucogingival junction. Make an internal bevel incision from the gingival margin to the bottom of the pocket to eliminate the diseased pocket wall. Elevate a partial thickness flap using careful sharp dissection.
Scale & plane the root surface
Prepare PRF membrane as described above
A fresh tetracycline solution (125 mg tetracycline/cc of saline) is prepared and applied to the root surfaces immediately before PRF membrane placement for 3 minutes.
Two PRF membranes are placed on surgical site superimposed in the opposite direction to cover the recessions and were positioned over the edge of the gingival collar above the CEJ to prevent epithelial migration.
Suture PRF membrane with resorbable sutures to the periosteum.
Return the flap & suture it at a level coronal to the pre-treatment position.
Cover the area with periodontal pack.
|
| Comparator Agent |
Sub-epithelial connective tissue graft |
Raise a partial thickness flap with a horizontal incision 2 mm away from the tip of the papilla & two vertical incisions 1 to 2 mm away from the gingival margin of the adjoining teeth. These incisions should extend at least half to one tooth wider mesiodistally than the area of gingival recession. Extend the flap to the mucobuccal fold.
Thoroughly plane the root, reducing its convexity.
Obtain a connective tissue graft using the above described method.A fresh tetracycline solution (125 mg tetracycline/cc of saline) is prepared and applied to the root surfaces immediately before graft placement for 3 minutes.
Place the connective tissue on the denuded root. Suture it with resorbable sutures to the periosteum.
Cover the graft with the outer portion of the partial thickness flap & suture it interdentally. At least half to two thirds of the connective tissue graft must be covered by the flap for the exposed portion to survive over the denuded root.
cover the area with dry foil & surgical pack
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Bilateral isolated Miller Class I and II recession defects
recession depths ≥2 mm
systemic health
age 18 years to 45 years
those consenting to participate in the study
|
|
| ExclusionCriteria |
| Details |
previous surgical attempt to correct gingival recession
smokers
poor Oral hygiene index
Psychiatric disorders
pregnancy
molar or premolar teeth with furcation involvement.
Pathologic mobility of teeth
Uncooperative patients.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Clinical attachment level
clinical probing depth
width of keratinized tissue
vertical gingival recession depth
gingival/mucosal thickness
WOUND HEALING INDEX (WHI)
MEASUREMENT OF POST-OPERATIVE DISCOMFORT
|
Clinical attachment level baseline ,4 & 9 months
clinical probing depth baseline ,4 & 9 months
width of keratinized tissue baseline ,4 & 9 months
vertical gingival recession depth baseline, 1 & 2 weeks,1,4 & 9 month
gingival/mucosal thickness baseline ,4 & 9 months
WOUND HEALING INDEX (WHI)1& 2 week
MEASUREMENT OF POST-OPERATIVE DISCOMFORT 1 & 2 week, 1 month
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
ESTHETIC OUTCOME MEASUEMENT |
after 9 months |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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)
|
01/11/2011 |
| 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
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
intention of this study is to find an alternative to gold standard( subepithelial connective tissue graft) with minimal expense of time & money using coronally advanced flap with PRF |