| CTRI Number |
CTRI/2025/07/090641 [Registered on: 10/07/2025] Trial Registered Prospectively |
| Last Modified On: |
05/07/2025 |
| 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 evaluate the effect of chitosan for treatment of deep dental carious lesion involving pulp |
|
Scientific Title of Study
|
Effectiveness of chitosan in vital pulp therapy of carious exposed permanent teeth- 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 Ritwik Bainsla |
| Designation |
Post Graduate Student |
| Affiliation |
Subharti Dental College and Hospital |
| Address |
Room No. 308, Department of Conservative Dentistry and Endodontics, Subharti Dental College and Hospital, Subharti University, Subhartipuram, NH58
Meerut
Meerut
UTTAR PRADESH
250005
India |
| Phone |
9999299621 |
| Fax |
|
| Email |
ritwikbainsla98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shikha Jaiswal |
| Designation |
Professor |
| Affiliation |
Subharti Dental College and Hospital |
| Address |
Room No. 308, Department of Conservative Dentistry and Endodontics, Subharti Dental College and Hospital, Subharti University, Subhartipuram, NH58
Meerut
Meerut
UTTAR PRADESH
250005
India |
| Phone |
9760707057 |
| Fax |
|
| Email |
shikhajais18@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shikha Jaiswal |
| Designation |
Professor |
| Affiliation |
Subharti Dental College and Hospital |
| Address |
Room No. 308, Department of Conservative Dentistry and Endodontics, Subharti Dental College and Hospital, Subharti University, Subhartipuram, NH58
Meerut
Meerut
UTTAR PRADESH
250005
India |
| Phone |
9760707057 |
| Fax |
|
| Email |
shikhajais18@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Room No. 308, Department of Conservative Dentistry and Endodontics, Subharti Dental College and Hospital, Subharti University, Subhartipuram, NH58
Meerut, Uttar Pradesh |
|
|
Primary Sponsor
|
| Name |
Dr Ritwik Bainsla |
| Address |
Room No. 308, Department of Conservative Dentistry and Endodontics, Subharti Dental College and Hospital, Subharti University, Subhartipuram, NH58, Meerut, Uttar Pradesh 250005,
India |
| 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 Ritwik Bainsla |
Subharti Dental College and Hospital |
Room No. 308, Department of Conservative Dentistry and Endodontics, Subharti University, Subhartipuram, Meerut
Meerut
UTTAR PRADESH |
9999299621
ritwikbainsla98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| University Ethics Committee Mediical, Swami Vivekanand Subharti University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A488||Other specified bacterial diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Chitosan |
Chitosan (C6H11NO4)n is a natural biopolymer made from chitin, which is found in the shells of crustaceans. Chitosan is a white, odorless, and biodegradable substance that has been widely studied for its various beneficial properties, particularly in medical, pharmaceutical, and dental fields. In dentistry, chitosan versatility is being explored for use in vital pulp therapy, dental implants, and as part of wound healing. It has shown to have antimicrobial effects, which is crucial in preventing bacterial infection in the pulp following exposure or injury. It is biocompatible and can integrate well with the natural tissues of the tooth and the surrounding dentin . It has demonstrated potential in promoting tissue regeneration and wound healing, which can assist in the recovery of injured pulp tissues. It has hemostatic qualities, and can promote cellular stimulation which makes it a great choice for pulp capping in vital pulp therapy. |
| Comparator Agent |
Mineral Trioxide Aggregate |
Mineral Trioxide Aggregate (MTA) is a hydrophilic and biocompatible endodontic cement, capable of stimulating healing and osteogenesis. It is placed on exposed part of pulp over which permanent restoration will be placed. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Pulp sensibility testing i.e. thermal or
electrical test showing vital pulp. Teeth with negative or mild tender on percussion and the mobility within normal limits.
Pre-operative signs and symptoms of reversible pulpitis or symptomatic irreversible pulpitis. No periapical pathology on radiographic assessment. The teeth should be restorable with any permanent restoration immediately. |
|
| ExclusionCriteria |
| Details |
Patients with general contraindications to dental treatment
Teeth with completed Root canal treatment or Vital pulp therapy
Teeth associated with swelling, abscess, fistula, or abnormal mobility
Teeth with external or internal resorption, prominent radiolucency at
the periapical regions or furcation or calcification.
Teeth with cracks, periodontitis or tooth fracture
Teeth not responsive to pulp sensibility test |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Patient responses like subjective and objective signs and symptoms. Pulp sensibility testing like thermal or electrical |
one three and six months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Intraoral periapical radiographs to rule out development of any periapical pathology and to evaluate for any evidence of formation of dentinal bridge |
six and nine months |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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 2 |
|
Date of First Enrollment (India)
|
01/08/2025 |
| 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="7"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - 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 - Study Protocol
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 - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [ritwikbainsla98@gmail.com].
- For how long will this data be available start date provided 28-06-2027 and end date provided 27-06-2032?
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
|
|
Brief Summary
|
A Vital Pulp Therapy(VPT) is more conservative approach for deep carious lesion to preserve and maintain pulp tissue in a healthy state. Due to lack of awareness about indication, technique and newer materials which have increased the success of VPT process. VPT can serve as a potential alternative to Root Canal Treatment in cases of deep carious lesions with compromised/inflammed pulpal tissue. Recently, there has been a paradigm shift in VPT procedures especially pulpotomy which now indicated for mature permanent teeth also. One of the major factor affect the success of VPT is choice of pulp capping material. This study would aim to test the newer bioactive material when used as a pulp capping material in vital pulp capping procedures performed in deep carious lesion. |