| CTRI Number |
CTRI/2020/06/025938 [Registered on: 17/06/2020] Trial Registered Prospectively |
| Last Modified On: |
17/06/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological
Dentistry |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Comparison of two plasma derivates as pulpotomy agents in human immature molars |
|
Scientific Title of Study
|
Comparative evaluation of Platelet Rich Plasma (PRP) and Platelet Rich Fibrin (PRF) as pulpotomy agents in young permanent molars: A Spilt Mouth Radomized 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 Devendra Patil |
| Designation |
Senior Lecturer |
| Affiliation |
Terna Dental College |
| Address |
Room no 221, Undergraduate division, Department of Paediatric and Preventive Dentistry, Terna Dental College, Phase II, Sector 22, Nerul, Navi Mumbai.
Mumbai (Suburban)
MAHARASHTRA
400706
India |
| Phone |
9930372999 |
| Fax |
|
| Email |
dev1987endra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Devendra Patil |
| Designation |
Senior Lecturer |
| Affiliation |
Terna Dental College |
| Address |
Room no 221, Undergraduate division, Department of Paediatric and Preventive Dentistry, Terna Dental College, Phase II, Sector 22, Nerul, Navi Mumbai.
MAHARASHTRA
400706
India |
| Phone |
9930372999 |
| Fax |
|
| Email |
dev1987endra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Devendra Patil |
| Designation |
Senior Lecturer |
| Affiliation |
Terna Dental College |
| Address |
Room no 221, Undergraduate division, Department of Paediatric and Preventive Dentistry, Terna Dental College, Phase II, Sector 22, Nerul, Navi Mumbai.
MAHARASHTRA
400706
India |
| Phone |
9930372999 |
| Fax |
|
| Email |
dev1987endra@gmail.com |
|
|
Source of Monetary or Material Support
|
| Terna Dental College, Nerul, Navi Mumbai, Maharashtra India |
|
|
Primary Sponsor
|
| Name |
Terna Dental College |
| Address |
Phase II, Sector 22, Nerul, Navi Mumbai, 400706 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Devendra Patil |
Terna Dental College |
Room no 224, PG Clinic, Department of Paediatric and Preventive Dentistry,Phase II, Sector 22, Nerul, Navi Mumbai.
Mumbai (Suburban)
MAHARASHTRA |
9930372999
dev1987endra@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Terna Dental College Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Patients are normal and healthy. Only carious permanent molars will be treated. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Platelet Rich Fibrin |
The required quantity of blood (1ml) will be drawn into 10 ml test tubes without an anticoagulant. Centrifugation will be done immediately using a tabletop centrifuge for 12 min at 2700 rounds per minute. The resultant product exhibits following three layers; platelet poor plasma at the surface, PRF clot in the middle, and red blood cells at the bottom. Sterile tweezers will be inserted into a test tube to retrieve the PRF clot. The platelet fibrin membrane was obtained by squeezing the PRF clot between the sterile dry gauges to drive out the fluids trapped in the fibrin matrix. |
| Intervention |
Platelet Rich Plasma |
One ml of peripheral venous blood will be drawn from the patient’s median cubital vein and transferred into a sterile evacuated 10 ml tube containing acetic acid citrate dextrose for anticoagulation and preservation of high concentration of platelets. These tubes will be then placed in centrifuge machine for first spin called as soft spin. The first spin will be performed at 2400 r.p.m for 10 minutes. This step separates the blood into three layers; top-most platelet poor plasma (PPP) layer, middle buffy layer, and bottom- most red blood cell layer. Using a sterile micro pipette, the PPP and buffy layer will be collected in a 5ml sterile glass tube without anticoagulant that undergoes the second spin (Hard spin) at 3600 r.p.m for 15 minutes, the PPP was concentrated at the upper two-thirds of the centrifuged sample, whereas the platelet pellet was concentrated at the bottom. The PPP will be removed and discarded soon after centrifugation leaving PRP at the lower third alone. PRP was activated with 10% calcium chloride 15 min before PRP clinical application. |
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
1. Large carious or mechanical exposure (more than 1 mm) of the vital coronal pulp
2. Absence of symptoms indicative of advanced pulpal inflammation such as spontaneous pain or history of nocturnal pain
3. Absence of clinical signs or symptoms suggesting a nonvital tooth such as suppurating sinus, soft tissue swelling.
4. Restorable tooth structure.
5. Bleeding should be controlled from the amputated pulp stumps within 5 minutes using sterile moist cotton pellets.
6. No evidence of external and/or internal root resorption
7. No widening of periodontal ligament (PDL) space
8. Absence of furcal or periapical radiolucency
9. Absence of canal calcification or pulp stone.
|
|
| ExclusionCriteria |
| Details |
1. Uncontrolled bleeding during the amputation of coronal pulp tissue
2. Children with medical conditions or any associated systemic condition
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of clinical success of PRP and PRF |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparison of clinical and radiographic success of PRP and PRF |
6 months and 12 months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 |
|
Date of First Enrollment (India)
|
01/07/2020 |
| 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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a randomized, split mouth design, single blind trail comparing the efficacy of Platelet Rich Plasma (PRP) and Platelet Rich Fibrin (PRF) as a pulpotomy agent in 25 children 7 to 10 year old with 50 young permanent molars present bilaterally in maxillary or mandibular arch. The study will be conducted in Terna Dental college, Navi mumbai, India. Pulpotomy procedure will be carried out in young permanent molars. The patient will be recalled after 3, 6 and 12 months for clinical and radiographical evaluation. The primary outcome measures will be efficacy of both the materials at 3 months follow up. The secondary outcomes will be efficacy of both the materials as pulpotomy agent at 6 month and 12 month follow up.
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