| CTRI Number |
CTRI/2025/01/079343 [Registered on: 24/01/2025] Trial Registered Prospectively |
| Last Modified On: |
22/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing Success Rates of Two Dental Materials for Protecting Exposed Pulps in Adult Molars |
|
Scientific Title of Study
|
Outcome of direct pulp capping With Premixed Bioceramic Material And Mineral Trioxide Aggregate In Mature Permanent Molars With Pulps Exposed During Carious Tissue Removal: A Randomized 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 Sachin Sunil Sawant |
| Designation |
Post Graduate Student |
| Affiliation |
Kaher KLE VIshwanath Katti Institute Of Dental Sciences |
| Address |
Department No 7 2nd Floor
Department of Conservative Dentistry and Endodontics
Kaher Institute Of Dental Sciences
JNMC Campus Nehru Nagar
Belgaum
Karnataka
590010
India
Belgaum KARNATAKA 590010 India |
| Phone |
8308549132 |
| Fax |
|
| Email |
sachinsawant1411@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sachin Sunil Sawant |
| Designation |
Post Graduate Student |
| Affiliation |
Kaher KLE VIshwanath Katti Institute Of Dental Sciences |
| Address |
Department of Conservative Dentistry and Endodontics
Department No. 7, 2nd Floor, KAHER KLE Vishwanath Katti Institiute of Dental Sciences, Belagavi, Karnataka
590010
India
Belgaum KARNATAKA 590010 India |
| Phone |
8308549132 |
| Fax |
|
| Email |
sachinsawant1411@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Sonal B Joshi |
| Designation |
Professor and Dean |
| Affiliation |
Kaher KLE VIshwanath Katti Institute Of Dental Sciences |
| Address |
Department No 7 2nd Floor Department of Conservative Dentistry and Endodontics
Kaher KLE Vishwanath Katti Institute Of Dental Sciences
JNMC Campus
Belgaum
Karnataka
590010
India
Belgaum KARNATAKA 590010 India |
| Phone |
9448141278 |
| Fax |
|
| Email |
jsonal70@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Kaher KLE
Vishwanath Katti Institute Of Dental Sciences JNMC
Campus Nehru Nagar
Belgaum
KARNATAKA
590010
India |
|
|
Primary Sponsor
|
| Name |
Dr Sachin Sunil Sawant |
| Address |
Department NO 7 2nd Floor Department of
Conservative Dentistry and Endodontics KAHER KLE
Vishwanath Katti Institute Of Dental Sciences JNMC
Campus Nehru Nagar Belgaum
Belgaum
Karnataka
590010
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 Sachin Sunil Sawant |
Kaher KLE Vishwanath Katti Institute of Dental Sciences, Belagavi, Karnataka- 590010 |
Department No.7 2nd Floor
Department Of Conservative Dentistry And Endodontics Kaher KLE Vishwanath Katti Institute Of Dental Sciences
JNMC Campus Nehru Nagar Belgaum
Belgaum
Karnataka
590010
India Belgaum KARNATAKA |
8308549132
sachinsawant1411@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Research and Ethics Committee KLE VKIDS |
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 |
Pulp Capping using Mineral Trioxide Aggregate |
The exposed pulp will be gently pressed with a cotton pellet soaked in 3% sodium hypochlorite. 2-3mm layer of Mineral Trioxide Aggregate will be placed according to manufacturers instructions followed by placement of Resin Modified Glass Ionomer Cement and Permanant Bulk Fill Composite Restoration on the same day. The patient will be assessed for a period of 6 month duration |
| Intervention |
Pulp capping using Premixed Bioceramic Material |
The exposed pulp will be gently pressed with a cotton pellet soaked in 3% sodium hypochlorite. 2-3mm layer of Premixed Bioceramic Material will be placed as per the manufacturers instructions followed by placement of Resin Modified Glass Ionomer Cement and Permanant Bulk Fill Composite Restoration on the same day. The patient will be assessed for a period of 6 month duration
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Pre-Caries Excavation inclusion criteria
A Permanent maxillary and mandibular first and second molars with large carious lesions involving either occlusal or proximal surfaces
B Radiographic examination revealing carious lesions in close proximity to the pulp
C Teeth with history of pain of short duration, caused by a specific irritant and disappearing when irritant is removed
D Patients with non-contributory medical history, good general health
E Patients ranging in the age group of 16-40 years
F Teeth with adequate coronal structure to ascertain proper isolation
Post-Caries excavation inclusion criteria
1 Pulp Exposures less than 1mm
2 Teeth which achieved haemostasis within 10 minutes
3 Non contaminated operating field |
|
| ExclusionCriteria |
| Details |
A. PATIENT SPECIFIC
1. Patients who refuse to consent for the procedure
2. Patients with any systemic diseases, pregnancy or immuno-compromised conditions
3. Patients allergic to lignocaine or any other material used in the trial
B SPECIFIC TO DIAGNOSIS
1. Teeth presenting a negative cold thermal test and a prolonged or no response to electric pulp testing
2. Teeth with symptoms and signs of irreversible pulpitis
3. Teeth exhibiting periapical radiolucencies on radiographic examination
4. Teeth exhibiting rarefying or condensing osteitis on radiographic examination
5. Teeth with internal or external resorption
6. Teeth showing positive responses to percussion or palpation
7. Retreatment cases
8. Teeth with aggressive periodontitis or mobility
TOOTH SPECIFIC
1 Teeth showing persistent pulpal hemorrhage after receiving 10 minutes of sodium hypochlorite dressing during the pulp capping procedure
2 Teeth with greater than1mm of pulpal exposure
3 Teeth which have been managed by Indirect Pulp Capping Procedure |
|
|
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 |
| To evaluate and compare the treatment outcome of direct pulp capping using Premixed bioceramic material or Mineral Trioxide Aggregate clinically and radiographically at 1 week, 3 months and 6 months |
1 week, 3 months and 6 months intervals.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the association of variables namely age, sex and caries location between the groups.
|
1 week, 3 months and 6 months intervals. |
|
|
Target Sample Size
|
Total Sample Size="70" Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "72"
Final Enrollment numbers achieved (India)="72" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
02/02/2025 |
| Date of Study Completion (India) |
23/01/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
In our day-to-day clinical practice most of the patients walk into our clinic with deep or extremely deep carious lesions. To ensure a line of treatment which has always been successful, dentists intervene by doing root canal treatment because of its high success rate. However after delivery of root canal treatment the vitality of the pulp is lost. The vitality of the pulp is essential to Preserve the defense mechanism of the pulp Enable dentin formation, Enhancement of the Survival rate- Vital Teeth > Endodontically treated teeth, Avoid root fracture. Because of this, we are mindful in excavating, deep, extremely deep carious lesions, because today there is a concept of selective caries excavation which advices removal of infected dentine and keeping the affected dentine in place and packing it with pulp capping material which is known as Indirect Pulp Capping. However, AAE , very firmly in there position statement have said hard or firm dentin and dentin below white spot enamel lesions is infected by bacteria in both active and arrested lesions. Histobacteriological studies have consistently shown the presence of chronic inflammatory cell infiltrates and subclinical pulp inflammation where carious tissues are retained, thus potentially compromising pulp vitality. Keeping this school of thought in effect, when caries are very deep we may adverently expose the pulp during the removal of caries itself. We have a Position Statement by our very own Indian Endodontic Society published in the year 2022 which states that Direct Pulp Capping(DPC) is considered the most conservative and simplest of the VITAL PULP THERAPIES. It involves applying a biomaterial directly onto the exposed pulp before immediately placing a permanent restoration under aseptic conditions. A randomized clinical trial provides the highest level of support for evidence based clinical practice. There have not been many randomized clinical trials conducted for comparing the outcomes of Premixed Bioceramic Material and Mineral Trioxide Aggregate in mature permanent molars with pulps exposed during carious tissue removal. As DPC is mostly a onevisit procedure, conservative, costeffective, preserving pulp vitality, immunological and proprioceptive function of dental pulp while delaying the restorative cycle, and is considered an ideal treatment option for India where the oral disease burden is high. Thus, there is a need for a randomized clinical trial to evaluate and compare the Treatment outcome of Direct Pulp Capping using the new Premixed Bioceramic Material and comparing it with Mineral Trioxide Aggregate which is advocated for direct pulp capping procedures today. |