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
|
|
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
|
|
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. |