CTRI Number |
CTRI/2023/06/053877 [Registered on: 14/06/2023] Trial Registered Prospectively |
Last Modified On: |
10/06/2023 |
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 effect of two different blood products for the treatment of receeding gums- A controlled randomized clinical study |
Scientific Title of Study
|
Comparative evaluation of efficacy of PRF & T-PRF for treatment of Cairo’s class I and II gingival recession A randomized controlled study. |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Richa Saroj |
Designation |
Post Graduate Student |
Affiliation |
K.M Shah Dental College and Hospital, Sumandeep Vidyapeeth |
Address |
room no 7, department of periodontology, K. M Shah Dental College and Hospital, Sumandeep Vidyapeeth, Piparia, Waghodia Road, Vadodara, Gujarat-391760
Vadodara GUJARAT 391760 India |
Phone |
7208892027 |
Fax |
|
Email |
richasaroj43@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Monali Shah |
Designation |
H.O.D, professor and PG guide |
Affiliation |
K.M Shah Dental College and Hospital, Sumandeep Vidyapeeth |
Address |
room no. 7 department of periodontology, K. M Shah Dental College and Hospital, Sumandeep Vidyapeeth, Piparia, Waghodia Road, Vadodara, Gujarat-391760
Vadodara GUJARAT 391760 India |
Phone |
9824003228 |
Fax |
|
Email |
smonali2011@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Richa Saroj |
Designation |
Post Graduate Student |
Affiliation |
K.M Shah Dental College and Hospital, Sumandeep Vidyapeeth |
Address |
Room no 7, department of periodontology, Sumandeep Vidyapeeth, Piparia, Waghodia Road, Vadodara, Gujarat-391760
Vadodara GUJARAT 391760 India |
Phone |
7208892027 |
Fax |
|
Email |
richasaroj43@gmail.com |
|
Source of Monetary or Material Support
|
K.M. SHAH dental college and hospital, sumandeep vidyapeeth
Dr. Monali Shah, Room no 7 department of periodontology K.M Shah dental college and hospital |
|
Primary Sponsor
|
Name |
Dr. Richa Saroj |
Address |
Vama Girls Hostel, Sumandeep Vidyapeeth, Piparia, Waghodia Road, Vadodara, Gujarat-391760 |
Type of Sponsor |
Other [Self Funded] |
|
Details of Secondary Sponsor
|
Name |
Address |
Dr Monali Shah |
Room No:7, K.M Shah Dental College and Hospital, Sumandeep Vidyapeeth, Piparia, Waghodia Road, Vadodara, Gujarat-391760 |
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Richa Saroj |
K.M Shah Dental College and Hospital |
Room no 7, department of periodontology, K.M.Shah dental college and hospital, piparia, waghodia road, vadodara-391760 Vadodara GUJARAT |
7208892027
richasaroj43@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Sumandeep Vidyapeeth Institutional Ethics Committee (SVIEC) |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: K060||Gingival recession, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
PRF |
Platelet Rich Fibrin (PRF) is the second generation platelet concentrate, developed first by Choukroun, et al. in PRF is a three-dimensional fibrin network that promotes accelerated wound healing, immunity and effective neovascularization, and it supports the three crucial steps of wound healing: ‘angiogenesis’, ‘immunity’ and ‘epithelial proliferation’. In addition, PRF, an autogenous fibrin matrix formed only of concentrated blood, provides successful clinical outcomes for the treatment of soft-tissue defects and comparable keratinized tissue gain and tissue thickness when combined with connective tissue grafts.
resorption time is 7-11 days |
Intervention |
T-PRF
|
T-PRF plays an important role in increasing soft tissue thickness. T-PRF is promising, especially in soft and hard tissue augmentation, due to its Fibrin structure, which is tighter than that of L-PRF, and it is prepared in Grade IV titanium tubes. It produces faster epithelization, less postoperative bleeding, and better wound healing than spontaneous healing. T-PRF also has osteoinductive properties similar to those of bone and preserves tissue volume. It has been found that it has better bio-compatibility, thin fibrin meshwork, and long resorption time when compared to other generations of platelet concentration
resorption time is 18-21 days |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
50.00 Year(s) |
Gender |
Both |
Details |
1. Participants between 18 and 50 years of age
2. Cairo Class I or II gingival recession defects measuring ≥ 2mm.
3. Vital teeth, free of faulty restorations.
4. Patients who gave informed consent for the study.
|
|
ExclusionCriteria |
Details |
1. History of smoking or tobacco consumption
2. Pregnant or lactating women
3. Patient with active periodontal infection.
4. Patients with systemic condition that contraindicate surgery.
5. Patients with removable or fixed dentures in the area of interest.
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
Method of Concealment
|
Other |
Blinding/Masking
|
Participant and Investigator Blinded |
Primary Outcome
|
Outcome |
TimePoints |
1. Width of keratinized Tissue
2. Recession Height
3. Recession Width |
Baseline - on the day of surgery & at 3 months |
|
Secondary Outcome
|
Outcome |
TimePoints |
1. Percentage Root Coverage
2. Thickness of Attached Gingiva |
Baseline- on the day of surgery & at 3 months |
|
Target Sample Size
|
Total Sample Size="36" Sample Size from India="36"
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 4 |
Date of First Enrollment (India)
|
01/07/2023 |
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)
|
Open to Recruitment |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Gingival recession is the apical
migration of gingival margin to the cemento-enamel junction (CEJ). The distance
between the CEJ and gingival margin gives the level of recession. Gingival
recession can be caused by periodontal disease, accumulations, inflammation,
improper flossing, aggressive tooth brushing, incorrect occlusal relationships,
and dominant roots. These can appear as localized or generalized gingival
recession. Although connective tissue
graft is a gold standard procedure, PRF can be used as an alternative procedure
by keeping patient’s comfort in mind. PRF is a three-dimensional fibrin network that promotes
accelerated wound healing, immunity and effective neovascularization, and it
supports the three crucial steps of wound healing: ‘angiogenesis’, ‘immunity’
and ‘epithelial proliferation’. In addition, PRF, an autogenous fibrin matrix
formed only of concentrated blood, provides successful clinical outcomes for
the treatment of soft-tissue defects and comparable keratinized tissue gain and
tissue thickness when combined with connective tissue grafts. A newer
platelet concentrate i.e. Titanium Activated PRF (T-PRF) is a 3rd generation
platelet concentrate that helps in regeneration of tissue. Titanium-Prepared,
Platelet-Rich Fibrin (T-PRF) was recently developed by Tunali, et al. that
avoids any negative effects caused by dry glass or glass-coated plastic
tubes. The method is built on the concept that Titanium tubes are
much more effective than glass tubes at stimulating clotting factors than
Chouckroun’s method. T-PRF plays an important
role in increasing soft tissue thickness. |