| CTRI Number |
CTRI/2024/04/065254 [Registered on: 05/04/2024] Trial Registered Prospectively |
| Last Modified On: |
26/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
To compare and evaluate the use of platelet rich fibrin and calcium silicate based cement with laser as an adjunct in pulpotomy of permanent teeth.
|
|
Scientific Title of Study
|
A Comparative evaluation of concentrated Platelet rich fibrin and Calcium Silicate based cement in Pulpotomy of permanent teeth using Laser - A randomized control trial |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Himi Rathore |
| Designation |
Junior Resident |
| Affiliation |
King George Medical University |
| Address |
Department of Conservative Dentistry & Endodontics
Faculty of Dental Sciences
King Georges Medical University
Lucknow- 226003
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
6392326079 |
| Fax |
|
| Email |
himi.rathore@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rakesh Kumar Yadav |
| Designation |
Professor |
| Affiliation |
King George Medical University |
| Address |
4,252, Vikas Nagar, Lucknow
Lucknow
UTTAR PRADESH
226022
India |
| Phone |
9415281156 |
| Fax |
|
| Email |
rakeshanita10@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rakesh Kumar Yadav |
| Designation |
Professor |
| Affiliation |
King George Medical University |
| Address |
4,252, Vikas Nagar, Lucknow
Lucknow
UTTAR PRADESH
226022
India |
| Phone |
9415281156 |
| Fax |
|
| Email |
rakeshanita10@yahoo.in |
|
|
Source of Monetary or Material Support
|
| department of conservative dentistry and endodontics, king george medical university lucknow |
|
|
Primary Sponsor
|
| Name |
Himi Rathore |
| Address |
E 34 Nirbhay Nagar Gailana Road,
Agra 282007 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Professor Rakesh Kumar Yadav |
4,252, Vikas Nagar, Lucknow |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Himi Rathore |
King George Medical University |
Conservative Dentistry and Endodontics, Faculty of Dental Sciences, King Georges Medical University,
Lucknow.
Lucknow
UTTAR PRADESH |
6392326079
himi.rathore@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| King George Medical University U.P. Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
healthy human with dental carious permanent molar teeth will be included in the study. |
| Patients |
(1) ICD-10 Condition: K025||Dental caries on pit and fissure surface, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Pulpotomy |
Deep caries from the permanent molar will be removed and pulpotomy will be performed in 4 different groups. The tooth will be restored with a regenerative material like calcium silicate based cement or platelet rich fibrin and laser will be used as an adjunct in 2 groups. biodentine a calcium silicate based cement group will act as a control group in this study.
Pulpotomy will be done using biodentine as a control group and further will be restored with GIC and composite. Follow up will be done at 1 month and 3 months.
Biodentine†calcium silicate based product which became commercially available in 2009 (Septodont, http://www.septodontusa.com/) and that was specifically designed as a “dentine replacement†material.The material is actually formulated using the MTA-based cement technology and the improvement of some properties. The powder component of the material consists of tricalcium silicate, dicalcium silicate, calcium carbonate and oxide filler, iron oxide shade, and zirconium oxide. Tricalcium silicate and dicalcium silicate are indicated as main and second core materials, respectively, whereas zirconium oxide serves as a radiopacifier. The liquid, on the other hand, contains calcium chloride as an accelerator and a hydrosoluble polymer that serves as a water reducing agent. It has also been stated that fast setting time, one unique characteristics of the product, is achieved by increasing particle size, adding calcium chloride to the liquid component, and decreasing the liquid content. The setting period of the material is as short as 9–12 minutes.
|
| Intervention |
Pulpotomy |
Pulpotomy is the term for removal of the coronal pulp with the intent of maintaining the vitality of the remaining radicular pulp tissue. Deep caries from the permanent molar will be removed and pulpotomy will be performed in 4 different groups. The tooth will be restored with a regenerative material like calcium silicate based cement or platelet rich fibrin and laser will be used as an adjunct in 2 groups. biodentine a calcium silicate based cement group will act as a control group in this study. Follow up will be done at 1 month and 3 months.
Materials used in intervention group will be autologous platelet rich fibrin made from patients blood under study and biodentine with laser and PRF with laser.
laser used at 3 Watts and 40 hertz.
these 3 groups will then be studied and compared with control group.
final restoration of the tooth will be done using glass ionomer cement and composite over it for 3 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Deep carious lesions including the permanent molars with symptoms of irreversible pulpititis.
No evidence of any clinical pathology and presence of no abnormal mobility
Vital permanent molars.
absence of any furcal radiolucency, periapical radiolucency.
|
|
| ExclusionCriteria |
| Details |
age more than 45 years or less than 18 years.
immature permanent molars or non vital permanent molars.
presence of abnormal mobility in the associated tooth.
presence of sinus tract, internal or external root resorbtion, pulpal necrosis of the associated tooth.
presence of root or crown fracture of the associated tooth. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| study of Dentin bridge and pulpal status |
evaluation will be done at 1 month and 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| gingival health, periodontal and periapical health status. |
evaluation will be done at 1 month and 3 months |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
14/04/2024 |
| 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="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This present study is a double blinded study which will be conducted in the Department of Conservative Dentistry and Endodontics, Faculty of Dental Science, King George’s Medical University, Lucknow. People of age group 18 to 45 years with carious mature permanent molar teeth will be randomly allocated into 4 groups. Randomization will be simple random sampling using random number table and a concealed allocation method using sequentially numbered, opaque, sealed envelope (SNOSE) will be used to randomly allocate the participants to 4 different groups. Interventional pulpotomy using Biodentine, platelet rich fibrin, biodentine along with laser and platelet rich fibrin along with laser will be done and compared. Follow up will be done at 1 month and 3 month to assess the primary outcomes which are dentin bridge formation and pulpal status (vitality of pulp) as well as secondary outcomes which are gingival health and periodontal and periapical health of the associated tooth. Evaluation at each visit will be done clinically and radigraphically to study these outcomes. |