| CTRI Number |
CTRI/2024/01/061819 [Registered on: 24/01/2024] Trial Registered Prospectively |
| Last Modified On: |
25/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
To compare and evaluate ozonoid olive oil, MTA and Calcium Hydroxide as an Indirect Pulp Capping Agent in Permanent Molars |
|
Scientific Title of Study
|
Evaluation of Ozonoid Olive Oil as an Indirect Pulp Capping Agent in Permanent Molars: A Randomised 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 Hemal Bajaj |
| Designation |
Post Graduate Student, Department of Conservative Dentistry and Endodontics |
| Affiliation |
Chhattisgarh Dental College and Research Institute, Sundra, Rajnandgaon 491441 |
| Address |
Chhattisgarh Dental College and Research Institute, Sundra, Rajnandgaon
Rajnandgaon
CHHATTISGARH
491441
India |
| Phone |
8349405020 |
| Fax |
|
| Email |
bajaj.hemal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hemal Bajaj |
| Designation |
Post Graduate Student, Department of Conservative Dentistry and Endodontics |
| Affiliation |
Chhattisgarh Dental College and Research Institute, Sundra, Rajnandgaon 491441 |
| Address |
Chhattisgarh Dental College and Research Institute, Sundra, Rajnandgaon
Rajnandgaon
CHHATTISGARH
491441
India |
| Phone |
8349405020 |
| Fax |
|
| Email |
bajaj.hemal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rashmi Nair |
| Designation |
Head of the Department Conservative Dentistry and Endodontics |
| Affiliation |
Chhattisgarh Dental College and Research Institute, sundra, rajnandgaon |
| Address |
Chhattisgarh Dental College and Research Institute, Sundra, Rajnandgaon
Rajnandgaon
CHHATTISGARH
491441
India |
| Phone |
9630145664 |
| Fax |
|
| Email |
rashmi.a.nair@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room No. 5, Department of conservative Dentistry and Endodontics, Chhattisgarh Dental College and Research Institute, Sundra, Rajnandgaon |
|
|
Primary Sponsor
|
| Name |
Dr Hemal Bjaaj |
| Address |
Chhattisgarh Dental College and Research Institute, Sundra, Rajnandgaon |
| 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 Hemal Bajaj |
Chhattisgarh Dental College and Research Institute, sundra, rajnandgaon |
Room No.-5, Department of Conservative Dentistry and Endodontics, Chhattisgarh Dental College and Research Institute, sundra, rajnandgaon
Rajnandgaon
CHHATTISGARH |
8349405020
bajaj.hemal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Chhattisgarh Dental College and Research Institute, Sundra, Rajnandgaon |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
normal healthy patients of age 19-40 years |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, (2) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Clinical and Radiographic Evaluation |
6 months |
| Comparator Agent |
MTA, Ozonoid Olive Oil, Calcium Hydroxide(Dycal) |
6 months |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Molars having occlusal or proximal deep carious lesion. Teeth with response suggestive of normal pulp or reversible pulpitis detected through electric pulp testing or thermal stimulation and radiographically teeth having a Periapical Index score of 1 was included |
|
| ExclusionCriteria |
| Details |
Patients with systemic diseases
Teeth with pulp exposure, spontaneous unprovoked pain, sinus opening, periodontium inflammation, mobility, cracked tooth, furcal radiolucency, internal or external resorption, and periapical lesion
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| considering dropout rates of 10 percent sample size will be 60 subjects and outcome is to compare and evaluate three different materials used for indirect pulp capping in permanent molars at 3 and 6 months of interval. |
3months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| clinical and radiographic evaluation |
3months and 6 months |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
27/01/2024 |
| 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="0"
Months="7"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
Published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Preservation of healthy pulp tissue is crucial as its plays a pivotal role in producing secondary dentin, peritubular dentin (sclerosis), and reparative dentin in response to various biologic and pathologic stimuli. So to maintain pulp vitality, Indirect Pulp Capping (IPC) is the treatment of choice in teeth with deep carious lesions Various materials have been employed for indirect pulp capping (IPC) of vital teeth with deep carious lesions. For many years, calcium hydroxide has been considered to be the ideal material for IPC. However owing to it limitations, alternative materials for IPC have gained popularity, such as mineral trioxide aggregate (MTA) and Biodentine Recently, Ozone therapy has gained popularity for the managemnet of deep carious lesion. It is regarded as one of the most effective antifungal, antiviral, and bactericidal substances due to its ability to oxidise cytoplasmic membranes and cell walls of microorganisms.Ozone in gaseous form was employed in various clinical studies, necessitating the use of specialised equipment to apply it to dentinal tissue. To overcome this shortcoming, ozone gas is mixed with olive oil by process of ozonation. This ozonated olive oil is easier to apply to dentinal tissue and doesn’t require special equipment; hence, it will be used in this investigation. So the aim of the study is clinical and radiographical evaluatation of the efficacy of ozonoid olive oil, MTA and Calcium Hydroxide as an IPC agent in permanent molars. |