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CTRI Number  CTRI/2024/12/078803 [Registered on: 31/12/2024] Trial Registered Prospectively
Last Modified On: 30/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Single Arm Study 
Public Title of Study   Effectiveness of bioceramic for treating Acute irreversible pulpitis- Clinical and Radiographical study 
Scientific Title of Study   Clinical and Radiographic performances of premixed Bioceramic reparative material in teeth with Acute Reversible Pulpitis – An Interventional Study 
Trial Acronym  NILL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Priyanca Panigrahi 
Designation  Post Graduate Trainee 
Affiliation  Institute of Dental Sciences, Siksha O Anusandhan, Bhubaneswar 
Address  Room no 9 , Department of Public Health Dentistry, Institute of Dental Sciences, Siksha O Anusandhan, Bhubaneswar

Khordha
ORISSA
751003
India 
Phone  7683879877  
Fax    
Email  panigrahipriyanca@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Dharmashree Satyarup 
Designation  Professor and Head  
Affiliation  Institute of Dental Sciences, Siksha O Anusandhan, Bhubaneswar 
Address  Room no 9 , Department of Public Health Dentistry, Institute of Dental Sciences, Siksha O Anusandhan, Bhubaneswar

Khordha
ORISSA
751003
India 
Phone  8008610999  
Fax    
Email  dharmashrees@soa.ac.in  
 
Details of Contact Person
Public Query
 
Name  Dr Dharmashree Satyarup 
Designation  Professor and Head  
Affiliation  Institute of Dental Sciences, Siksha O Anusandhan, Bhubaneswar 
Address  Room no 9 , Department of Public Health Dentistry, Institute of Dental Sciences, Siksha O Anusandhan, Bhubaneswar


ORISSA
751003
India 
Phone  8008610999  
Fax    
Email  dharmashrees@soa.ac.in  
 
Source of Monetary or Material Support  
Institute of Dental Sciences , Siksha O Anusandhan, sum hospital road,Bhubaneswar, Odisha, pincode- 751003 
 
Primary Sponsor  
Name  Priyanca Panigrahi 
Address  Institute of dental sciences, Room no 9, Department of Public Health Dentistry, Institute of Dental Sciences , Bhubaneswar 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Priyanca Panigrahi  Institute of Dental sciences  Room no 9, Department of public health dentistry, Institute of dental sciences bhubaneswar , Siksha O Anusandhan , Bhubaneswar
Khordha
ORISSA 
7683879877

panigrahipriyanca@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC - INSTITUTE OF DENTAL SCIENCES,Siksha O Anusandhan deemed to ne university ( Accredited NAAC of UGC )  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K025||Dental caries on pit and fissure surface,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Biodentine ( Bio C Repair) Tricalcium Silicate (C3 S) Dicalcium Silicate (C2 S) Tricalcium Aluminate Calcium Oxide Zirconium Oxide Silicon Oxide Polyethylene Glycol Iron Oxide  After the baseline examination, disinfection of the cavity will be performed with 2.5% sodium hypochlorite followed by removal of the carious dentin, using a tungsten carbide ball bur. Caries removal will be performed first on the margins to avoid pulpal invasion until the infected dentin is removed. The endodontic access cavity under local anesthesia will be made using a high-speed turbine with cooling water. Coronal pulp tissue will be removed using spoon excavator . The pulp chamber will be irrigated with saline solution to remove any pulp traces, and haemostasis will be performed with a gentle application of cotton dry pellet on top and repeated if required up to 6 min; bleeding time will be recorded. After maintaining a dry field for 5-10mins premixed Biodentine cement (Bio c repair) will be placed in the pulp chamber using plastic instruments followed by the placement of posterior glass ionomer cement. 2. After a follow up of 1 week with respect to outcome measures , pain will be reassessed after percussion and cold stimulus. The compatibility of the restoration will also be assessed. The radiographical assessments will be done at the intervals of 3, 6 and 9 months respectively to assess the periapical healing through radiographs using Orstavick et.al Periapical Index (1986) and scores of 3 or more will be considered as non-healing.  
Comparator Agent  Not applicable   Not applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. 20 years and above with matured pulp and co-operative
2. Positive responses to cold stimulus and verbal pain
3. Occlusal caries involving less than ≤ 2 walls of a teeth.
4. Teeth that can be restored.
5. Patients with occlusal caries of 1or 2 walled defect
 
 
ExclusionCriteria 
Details  1. Non co-operative patient.
2. Those who deny consent to participate
3. Teeth with open apex
4. Negative response to cold stimulus and verbal pain.
5. Irreversible large bone defect and periapical changes.
6. Presence of sinus tract/swelling.
7.Teeth with furcation involvement and periodontal pockets.
8. Grossly decayed tooth and root stump.
9. Teeth with calcified pulp and root resorption in pre-operative radiograph.
10. Molars with a preoperative clinical sign of complete or partial pulp necrosis
11. Absence of bleeding from a canal or uncontrollable pulp hemorrhage (more than 5 minutes) in at least 1 canal.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
periapical healing.
ostarvick et al radiograph criteria. 
3 months
6 months
9 months
 
 
Secondary Outcome  
Outcome  TimePoints 
Assesing the formation of Reparative dentine   3 months
6 months
9 months 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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/ Phase 3 
Date of First Enrollment (India)   31/01/2025 
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  

Baseline examination -This includes an intra-oral examination using a mouth mirror and probe to check the extent of caries clinically. The dental caries lesion will be identified using International Caries Detection and Assessment System (Code V and VI). The pain intensity will be assessed clinically based on the presence of Tender on Percussion and Visual Analogue Scale (VAS) along with pulp vitality using cold stimulus test where an ice stick will be placed for 3-5sec on the middle third of respected tooth. If the patient gives a positive response for the test, the next step will be assessment of radiographs that will be taken for the respective tooth to assess the carious extent and periapical changes using Orstavick et al (1986) periapical index  that will be scored as follows;

1 Normal periapical structures

2 Small changes in the bone structure

3 Change in the bone structure with mineral loss

4 Periodontitis with a well-defined radiolucent area

5 Severe periodontitis with exacerbating features


Method of application of Biodentine:

1.After the baseline examination, disinfection of the cavity will be performed with 2.5% sodium hypochlorite followed by removal of the carious dentin, using spoon excavator Caries removal will be performed first on the margins to avoid pulpal invasion until the infected dentin is removed. The endodontic access cavity under local anesthesia will be made using a high-speed turbine with cooling water. Coronal pulp tissue will be removed using a diamond bur. The pulp chamber will be irrigated with saline solution to remove any pulp traces, and haemostasis will be performed with a gentle application of cotton dry pellet on top and repeated if required up to 6 min; bleeding time will be recorded. After maintaining a dry field for 5-10mins premixed Biodentine cement (Bio c repair) will be placed in the pulp chamber using plastic instruments followed by the placement of posterior glass ionomer cement. 

2. After a follow up of 1 week with respect to outcome measures , pain will be reassessed after percussion and cold stimulus. The compatibility of the restoration will also be assessed. The radiographical assessments will be done at the intervals of 3, 6 and 9 months respectively to assess the periapical healing through radiographs using Orstavick et.al Periapical Index (1986) and scores of 3 or more will be considered as non-healing.


 
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