| CTRI Number |
CTRI/2022/04/042044 [Registered on: 21/04/2022] Trial Registered Prospectively |
| Last Modified On: |
12/04/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical effectiveness of newer pulpotomy agents |
|
Scientific Title of Study
|
Clinical effectiveness of Concentrated Growth Factor and injectable bioceramic material compared to MTA as pulpotomy agent in Permanent Mature Molar with Symptomatic Irreversible Pulpitis- a randomized controlled clinical trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
S B Divya |
| Designation |
Post graduate |
| Affiliation |
Saveetha Dental College and Hospitals |
| Address |
Saveetha Dental College
No. 162, Poonamalle High Road,
Chennai, Tamil nadu,
India.
Department of Conservative Dentistry and Endodontics.
(Clinic no. 21)
Chennai
TAMIL NADU
600077
India |
| Phone |
|
| Fax |
|
| Email |
divyasena03@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M S Nivedhitha |
| Designation |
Professor and Head of the Department |
| Affiliation |
Saveetha Dental College and Hospitals |
| Address |
Saveetha Dental College
No. 162, Poonamalle High Road,
Chennai, Tamil nadu,
India.
Department of Conservative Dentistry and Endodontics.
(Clinic 21)
Chennai
TAMIL NADU
600077
India |
| Phone |
|
| Fax |
|
| Email |
nivedhithamallisureshbabu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr M S Nivedhitha |
| Designation |
Professor and Head of the Department |
| Affiliation |
Saveetha Dental College and Hospitals |
| Address |
Saveetha Dental College,
No. 162, Poonamalle High Road,
Chennai, Tamil nadu,
India.
Department of Conservative Dentistry and Endodontics.
(Clinic 21)
Chennai
TAMIL NADU
600077
India |
| Phone |
|
| Fax |
|
| Email |
nivedhithamallisureshbabu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saveetha Dental College and Hospital,
Saveetha Institute of Medical and Technical Sciences, Saveetha University.
|
|
|
Primary Sponsor
|
| Name |
S B Divya |
| Address |
No. 162, Poonnamalee High Road, Chennai, Tamil nadu.
Pin code- 600077 |
| Type of Sponsor |
Other [Self] |
|
|
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 M S Nivedhitha |
Saveetha Dental College and Hospitals |
No. 162, Poonamallee High Road,
Chennai- 600077.
Department of Conservative Dentistry and Endodontics.
(Clinic 21)
Chennai
TAMIL NADU |
9840912367
nivedhithamallisureshbabu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethical Committee |
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: K040||Pulpitis, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bio C Repair |
Injectable bioceramic material by Angelus company from Brazil to be used as pulpotomy agent |
| Intervention |
Concentrated Growth Factor |
Concentrated Growth Factor Is autologous platelet factor prepared from patient’s blood and used as pulpotomy agent |
| Comparator Agent |
Mineral Trioxide Aggregate(MTA) |
MTA Angelus( Bioceramic reparative cement) by company Angelus from Brazil, to be used as pulpotomy agent |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients with symptomatic Irreversible Pulpitis of age 18 to 40 years permanent mature molar teeth with symptomatic irreversible pulpitis
2)Both Maxillary and Mandibular molar teeth.
3) A clinical diagnosis consistent with irreversible pulpitis will be established in all cases based on a history of severe spontaneous lingering pain that could be reproduced by cold testing.
4)Teeth which are tender to percussion can be included but those with periapical lesions, resorption of root must be excluded.
|
|
| ExclusionCriteria |
| Details |
1)Patients < 18years of age.
2)Patients of age > 40 years of age
3)Medically compromised patients
4)Pregnant and lactating women.
5)Patients undergoing fixed orthodontic therapy
6)Patients with facial deformity including cleft lip/palate.
7)Teeth with apical periodontitis.
8)Teeth with fracture or crack lines.
9)Teeth with abrasion on the same tooth.
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Post operative pain , tenderness and swelling (yes or no)
Pain will be assessed using Visual Analog Scale (VAS)
|
Post operative pain will be assessed after 24 hours and 48 hours, tenderness and swelling (yes or no)will be checked after 48 hours and 3 months
Pain will be assessed using Visual Analog Scale (VAS)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Presence of periapical lesions at 3, 6 & 12 months recall. Dentin bridge formation at 12 months interval through CBCT radiographic analysis.
|
3,6,12 months |
|
|
Target Sample Size
|
Total Sample Size="81"
Sample Size from India="81"
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)
|
12/05/2022 |
| 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="1"
Months="2"
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)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - Nil
- For how long will this data be available start date provided 29-05-2023 and end date provided 29-01-2027?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
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Brief Summary
|
Background and Rationale:The traditional treatment modality for permanent mature teeth diagnosed with irreversible pulpitis is pulpectomy, also known as nonsurgical root canal treatment (NSRCT)(Santos et al. 2021).However this reduces the survival time of the tooth(Caplan et al. 2005). Pulpotomy has been proposed as an alternative for management of irreversible pulpitis in permanent teeth with closed apices (Alqaderi et al. 2016).Choice of pulpotomy agent is an important decision factor which has an influence on the success rate of the treatment . Concentrated Growth Factor and injectable bioceramic material iRoot Bp will be compared with MTA as pulpotomy agent .
Materials and methods: Population: Patients who have permanent mature molar with symptomatic Irreversible Pulpitis Intervention: CGF, iRootBP Comparison: MTA Outcome: Group A: MTA Group B: CGF Group C: iRootBp Primary outcome: Post operative pain, tenderness and swelling (yes or no) Secondary outcome: Presence of periapical lesions at 3, 6 & 12 months recall. Dentin bridge formation at 12 months interval through CBCT radiographic analysis. |