| CTRI Number |
CTRI/2022/10/046294 [Registered on: 10/10/2022] Trial Registered Prospectively |
| Last Modified On: |
07/10/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Management of Miller’s class I/II gingival recession with titanium platelet-rich fibrin membrane: Case series.
|
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Scientific Title of Study
|
CLINICAL EVALUATION OF TITANIUM-PRF COMPARED TO CONNECTIVE TISSUE GRAFT IN THE MANAGEMENT OF MILLER’S CLASS I/II RECESSION CASES: A 6 MONTHS RANDOMISED CONTROLLED 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 Kartik Radadiya |
| Designation |
Post Graduate |
| Affiliation |
Pacific Dental College and Hospital |
| Address |
Pacific Dental College and Hospital ,Airport Road ,Debari, Udaipur ,Rajasthan-313024
Udaipur
RAJASTHAN
313024
India |
| Phone |
9106591119 |
| Fax |
|
| Email |
kartikradadiya36@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aditi Mathur |
| Designation |
Professor |
| Affiliation |
Pacific Dental College and Hospital |
| Address |
Pacific Dental College and Hospital ,Airport Road ,Debari, Udaipur ,Rajasthan-313024
Udaipur
RAJASTHAN
313024
India |
| Phone |
9929826446 |
| Fax |
|
| Email |
draditimathur@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kartik Radadiya |
| Designation |
Post Graduate |
| Affiliation |
Pacific Dental College and Hospital |
| Address |
Pacific Dental College and Hospital ,Airport Road ,Debari, Udaipur ,Rajasthan-313024
Udaipur
RAJASTHAN
313024
India |
| Phone |
9106591119 |
| Fax |
|
| Email |
kartikradadiya36@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pacific Dental college and Hospital |
|
|
Primary Sponsor
|
| Name |
DR KARTIK RADADIYA |
| Address |
Pacific Dental College and Hospital,Airport Road ,Debari ,Udaipur , Rajasthan-313024 |
| Type of Sponsor |
Other [SELF FUNDED] |
|
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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 KARTIK RADADIYA |
Pacific Dental College and Hospital |
Room No. 10,DEPARTMENT OF PERIODONTICS
Udaipur
RAJASTHAN |
9106591119
kartikradadiya36@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Pacific Academy of Higher Education & Research University |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
| Intervention |
ROOT COVERAGE |
The surgical procedure will start with local infiltration of anesthesia in the operating site.
Sulcular incisions on the labial aspect of the tooth will be performed with no. 15C blade to begin the partial-thickness dissection. The split-thickness dissection will be then extended until continuity is established between all the recession sites without raising the papillae. In both the groups the graft / membrane will be placed in the prepared recipient site and stabilized using suture with the overlying gingival flap will be done.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Teeth with Miller’s class I or II gingival recession.
2.Vital teeth with no restoration or decay.
3.Teeth with no mobility and no occlusal trauma.
4.Patients who can follow the instructions and maintain a good oral hygiene.
|
|
| ExclusionCriteria |
| Details |
1.Pregnant and lactating women.
2.Patients having fixed orthodontic or removable prosthesis on surgical sites.
3.Patients with smoking habits.
4.The presence of periodontal pockets exceeding 5 mm in the teeth undergoing treatment.
5.Any systemic disease likely to influence coagulation.
6.Patients on anti-coagulant medicines
|
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| It is expected that the use of T-PRF will be equally effective to CTG in gaining recession depth and recession width . |
Baseline,14 day,1 month ,3 months , 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| With T-PRF improvement in clinical parameters such as RD, RW, PPD, CAL and KTW. |
BASELINE, 14 DAYS, 1 MONTH, 3 MONTHS, 6 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
12/10/2022 |
| 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="0"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Gingival Recession is defined
as exposure of the root surface due to apical migration of the gingival margin
beyond the cementoenamel junction.
Treatment with Titanium-PRF autogenous graft allows
for thicker fibrin meshwork, continued integrity,
tightly woven and thicker fibrin scaffold, more polymerized fibrin formation, longer
resorption time (30 days), increased duration of released growth factor, excellent
biocompatibility, better hemocompability and platelet activation.
AIM:
To clinically evaluate and compare the outcome of Titanium-Platelet
rich fibrin (T-PRF) membrane versus Connective Tissue Graft (CTG) using the
conventional tunnel technique, in treatment of Miller’s
class I/II gingival
recession sites, over a period of 6
months.
METHODOLOGY
Present
study is a randomized controlled clinical trial with a Sample size of 20 subjects,
having Miller’s class I/II recession sites. Following the selection of
recession sites, patients will be randomly divided into two groups: GROUP 1 (TEST
GROUP): - 10 sites with Miller’s class I/II gingival recessions to be treated with T-PRF. GROUP 2
(CONTROL GROUP): - 10 sites with Miller’s class I/II gingival recession to be treated
with CTG. Clinical Parameters to be assessed at Baseline (pre surgical phase), 1
Month, 3 Months and 6 Months after therapy are: Recession depth ,Recession width ,Probing pocket depth ,Clinical attachment level, Keratinized tissue width. The visual
analog scale (VAS) will be measured during procedure and at 14 days after
therapy. Wound Healing Index will be measured at 14 days and 1month after
therapy. The statistical analysis will be done using paired ‘t’test and unpaired
‘t’test.
PROPOSED
CONCLUSION:-
It is expected
that the use of T-PRF will be equally effective to CTG in treatment of
Miller’s class I/II gingival recession. |