| CTRI Number |
CTRI/2025/01/079476 [Registered on: 24/01/2025] Trial Registered Prospectively |
| Last Modified On: |
24/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical comparison of three dental materials on dental pulp tissue |
|
Scientific Title of Study
|
To compare the efficacy of new light cure MTA with existing bioceramics in management of exposed dental pulp tissue: A randomized control clinical 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 SRINIVASA T S |
| Designation |
PROFESSOR & HOD |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCESGORAKHPUR |
| Address |
ROOM NO 7 DEPT OF DENTISTRY ALL INDIA INSTITUTE OF MEDICAL SCIENCES
KUNRAGHAT GORAKHPUR ROOM NO 7 DEPT OF DENTISTRY ALL INDIA INSTITUTE OF MEDICAL SCIENCES
KUNRAGHAT GORAKHPUR Gorakhpur UTTAR PRADESH 273008 India |
| Phone |
9993519183 |
| Fax |
|
| Email |
seen79@rediffmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr SRINIVASA T S |
| Designation |
PROFESSOR & HOD |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES GORAKHPUR |
| Address |
ROOM NO 7 DEPT OF DENTISTRY ALL INDIA INSTITUTE OF MEDICAL SCIENCES
KUNRAGHAT GORAKHPUR ROOM NO 7 DEPT OF DENTISTRY ALL INDIA INSTITUTE OF MEDICAL SCIENCES
KUNRAGHAT GORAKHPUR Gorakhpur UTTAR PRADESH 273008 India |
| Phone |
9993519183 |
| Fax |
|
| Email |
seen79@rediffmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Srinivasa T S |
| Designation |
PROFESSOR & HOD |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES GORAKHPUR |
| Address |
ROOM NO 7 DEPT OF DENTISTRY ALL INDIA INSTITUTE OF MEDICAL SCIENCES
KUNRAGHAT GORAKHPUR
Gorakhpur UTTAR PRADESH 273008 India |
| Phone |
9993519183 |
| Fax |
|
| Email |
seen79@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| ALL INDIA INSTITUTE OF MEDICAL SCIENCES GORAKHPUR |
|
|
Primary Sponsor
|
| Name |
Dr Srinivasa T S |
| Address |
ROOM NO 7 DEPT OF DENTISTRY ALL INDIA INSTITUTE OF MEDICAL SCIENCES GORAKHPUR
KUNRAGHAT GORAKHPUR |
| Type of Sponsor |
Other [SELF FUNDED] |
|
|
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 Srinivasa T S |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES GORAKHPUR |
OPD Room no 7, Dept of Dentistry Gorakhpur UTTAR PRADESH |
9993519183
seen79@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL HUMAN ETHICS COMMITTEE AIIMS GORAKHPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K040||Pulpitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Biodentine |
Mix for 30 seconds and place the biodentine mixture on the exposed dental pulp tissue with a sterilized appropriate instrument. Restore with appropriate restorative material. |
| Intervention |
Light cure Mineral trioxide aggregate |
Application of Dentigrate Light cure MTA on the pulp exposure using a small applicator and light cure for 1 minute. After setting of MTA, restore with appropriate restorative material. |
| Intervention |
Mineral Trioxide Aggregate(powder liquid form) |
Mix the powder and liquid MTA for 30 seconds the and place the cement on the exposed dental pulp tissue with an appropriate instrument. Restore with appropriate restorative material. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1 Tooth with deep caries
2 Permanent 1st and 2nd molar
3 Carious exposure 0.5mm to 2mm
4 Tooth with diagnosis of reversible pulpitis
5 Positive pulp response.
|
|
| ExclusionCriteria |
| Details |
1 Presence of crowns, removable partial dentures,
2 Patient with history of orthodontic treatment,
3 Patient with open bite malocclusion
4 Primary teeth
5 Teeth with irreversible pulpitis/ pulp necrosis/ presence of periapical lesion
6 Tooth with periodontal disease, calcified canal, internal or external resorption
7 Pulpal bleeding that could not be controlled within 10 minutes
8 Patient with tumor(s) of the soft or hard tissues of the oral cavity
9 Any developmental disorders
10.Congenital defect of tooth, |
|
|
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 |
| Primary outcome will be clinical and radiographic success rates at the 1,3, 6 and 12 months follow up |
1,3, 6, 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| postoperative pain |
7 days |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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 3 |
|
Date of First Enrollment (India)
|
10/02/2025 |
| 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="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Direct exposure of the pulp to the oral environment breaks the integrity of the pulp-dentin complex, if not treated properly, will lead to apical periodontitis, which eventually requires root canal treatment or extraction. The treatment widely practiced for exposed dental pulp is considered root canal treatment as healing of the pulp tissue is unpredictable. Direct pulp capping has been described as a method that utilizes regenerative capacity of human dental pulp cells. The procedure of pulp capping relies primarily on the ability of pulpal tissue to heal and its ability to form hard tissue barriers called reparative dentin. Pulp capping material should provide a suitable condition to encourage regeneration of the dentin-pulp complex which will induce differentiation of odontoblast like cells, be antibacterial, biocompatible, and nontoxic. Calcium hydroxide introduced in 1930 by Herman was considered gold standard for the treatment of direct pulp exposure by reparative dentine formation and strong antibacterial property. Drawbacks such as high solubility, low mechanical resistance and lack of bond to dentine often lead to tunnel defect formation with use of calcium hydroxide. [2] Many formulations have been proposed to overcome the drawback of calcium hydroxide such as resin infiltrate glass ionomer, calcium phosphate, bio-silicates material such as MTA and Biodentine, light cure tricalcium silicate cement. Biodentine have high mechanical properties, excellent biocompatibility and bioactive behavior. Due to its good sealing ability with dentin, it is used as a dentin replacement material as pulp protection, temporary restoration, cervical filling, direct and pulp capping and pulpotomy. Currently MTA introduced by Torabinejad in 1990 has gain popularity as a material of choice for direct pulp capping. The success rates of direct pulp capping were reported to range from 67.4% at 3 years and 97.96% after a 9-year follow-up for MTA. MTA elevates the expression of transcription factors, induces dentin bridge formation, possesses biocompatibility and sustains a high pH for a longer duration and a close physiochemical seal with dentin that forms an insoluble barrier to prevent microleakage. |