| CTRI Number |
CTRI/2024/12/077953 [Registered on: 11/12/2024] Trial Registered Prospectively |
| Last Modified On: |
26/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
A comparative clinical and radiological evaluation of pulp capping agents in permanent teeth with carious pulp exposure – an in-vivo study. |
|
Scientific Title of Study
|
A comparative clinical and radiological evaluation of biodentine, platelet-rich fibrin, and acemannan as direct pulp capping agent in permanent teeth with various pulp exposure – an in-vivo study. |
| 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 Manoj M Dhavalagi |
| Designation |
Postgraduate student |
| Affiliation |
K V G Dental College and Hospital |
| Address |
Room 6 Department of conservative dentistry and endodontics K V G Dental College and Hospital Kuringibhag Sullia
Dakshina Kannada KARNATAKA 574327 India |
| Phone |
09606373963 |
| Fax |
|
| Email |
drmanojmdhavalagi@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Moksha Nayak |
| Designation |
Principal and Professor |
| Affiliation |
K V G Dental College and Hospital |
| Address |
Room 6 Department of conservative dentistry and endodontics K V G Dental College and Hospital Kuringibhag Sullia
Dakshina Kannada KARNATAKA 574327 India |
| Phone |
9448026828 |
| Fax |
|
| Email |
moksha.nayak@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Manoj M Dhavalagi |
| Designation |
Postgraduate student |
| Affiliation |
K V G Dental College and Hospital |
| Address |
Room 6 Department of conservative dentistry and endodontics K V G Dental College and Hospital Kuringibhag Sullia
Dakshina Kannada KARNATAKA 574327 India |
| Phone |
09606373963 |
| Fax |
|
| Email |
drmanojmdhavalagi@gmail.com |
|
|
Source of Monetary or Material Support
|
| K V G Dental College and Hospital Kuringibhag Sullia Dakshina Kannada Karnataka 574327 |
|
|
Primary Sponsor
|
| Name |
Manoj M Dhavalagi |
| Address |
K V G Dental College and Hospital Kuringibhag Sullia Dakshina Kannada Karnataka 574327 |
| 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 Manoj M Dhavalagi |
K V G Dental College and Hospital |
Room 6 Department of conservative dentistry and endodontics K V G Dental College and Hospital Kuringibhag Sullia Dakshina Kannada Karnataka 574327 Dakshina Kannada KARNATAKA |
09606373963
drmanojmdhavalagi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| K V G Dental College and Hospital |
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 |
| Comparator Agent |
Acemannan |
Acemannan Will be used as pulp capping agent once based on size of pulp exposure |
| Intervention |
BIODENTINE
|
BIODENTIN Will be used as pulp capping agent once based on size of pulp exposure
|
| Comparator Agent |
Platelet Rich Fibrin (PRF) |
PRF Will be used as pulp capping agent once based on size of pulp exposure |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
• Patients willing to participate in the study.
• Both males and females will be included within the age group of 18-35 years.
• Posterior tooth with a deep carious lesion with no pain and swelling for the involved tooth.
• Any tooth positive response to vitality testing (electric pulp tests and cold test), the response should be comparable to the contralateral tooth.
• Tooth responding negative to percussion test.
• Tooth with carious pulpal exposure not larger than 2 mm in diameter with mild symptoms and normal periapical tissues (Periapical index score ≤2)
• The bleeding from exposed pulp which can be resolved within less than five minutes.
• Tooth which could be restored with composite, amalgam, and stainless stain crown (restorable tooth structure).
|
|
| ExclusionCriteria |
| Details |
• Teeth with large caries exposure with symptoms
(Teeth associated with pain and presence of soft tissue swelling or abscess in relation to involved teeth.)
• Teeth with Uncontrolled bleeding during caries removal.
• Teeth with cracks and defects and traumatic pulp exposure.
• Presence of signs and symptoms of irreversible pulpitis and periapical pathologies.
• Teeth that cannot be isolated with a rubber dam.
• Teeth with low prognosis which includes abnormal mobility. (Miller’s classification grade II and grade III)
• Presence of pulp canal obliteration or calcification.
• Evidence of internal and external root resorption.
• Pregnant and lactating mothers.
|
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the clinical and radiological outcomes of direct pulp capping using Biodentin, Platelet Rich Fibrin, and Acemannan in cariously exposed vital permanent teeth. |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
•To evaluate the clinical and radiological outcome of direct pulp capping using Biodentine in cariously exposed vital permanent teeth.
•To evaluate the clinical and radiological outcome of direct pulp capping using Platelet Rich Fibrin in cariously exposed vital permanent teeth.
•To evaluate the clinical and radiological outcome of direct pulp capping using Acemannan in cariously exposed vital permanent teeth.
•To compare the above three groups.
|
6 months |
|
|
Target Sample Size
|
Total Sample Size="45" Sample Size from India="45"
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)
|
01/01/2025 |
| 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="2" Months="2" 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
|
The current treatment strategies in endodontics are undergoing a paradigm shift towards minimal invasive biological procedures in relation to the management of deep caries and vital pulp exposure. The concept of vital pulp therapy first coined by Dr. Louis I. Grossman, serves as a cornerstone for modern endodontics with advances in biomaterial and regenerative techniques. Various materials like calcium hydroxide, Zinc Oxide Eugenol (ZOE) Cement, Theracal, Mineral Trioxide Aggregate, Biodentine, Glass Ionomer/Resin Modified Glass Ionomer have been tested for direct pulp capping of cariously exposed vital teeth. Biodentine is an innovative cement made of tricalcium silicate with inherent bioactive characteristics. The antibacterial properties of Biodentine are attributed to its high pH, which is achieved by the action of hydroxyl ions on the surrounding tissue. A thin layer of coagulative necrosis forms between the vital pulp tissue and Biodentine because of the increase in pH. There has been considerable research performed on this material as a direct pulp capping agent since its launch in 2009. A biological approach towards pulp capping is Platelet concentrates which promote differentiation of new odontoblasts by preserving remaining odontoblasts. Platelet-rich fibrin derived from blood is a second-generation platelet concentrate introduced by Choukroun in 2001. It contains a multitude of growth factors which is conducive to healing such as transforming growth factor β1, platelet-derived growth factor, and insulin-like growth factor. It exhibits varied properties such as cell migration, cell proliferation, cell attachment, and cell differentiation. Clinical studies have shown that Platelet Rich Fibrin promotes soft tissue and bone regeneration. In dentistry, a wide range of herbal extracts like Baicalin, Propolis, Nigella stevia, Genipin, Acemannan, and Galla Chinensis Extract have been employed to deal with the flaws of conventional treatment for vital pulp therapy. Among all the herbal extracts, Acemannan is a natural polysaccharide with good biodegradability and biocompatibility. It is an extract from aloe vera and has a range of therapeutic uses in pulp capping mainly because it stimulates dentin regeneration via increased pulp cell proliferation, differentiation, growth factor expression, extracellular matrix synthesis, and mineral deposition. Pre-clinical and clinical evidence both favor the application of this herbal extract to help in the regeneration of dentin. Biodentine has shown to have efficient physical and biological properties as a pulp-capping material with a success rate of 83.4% to 90.9%.However, due to its limited insufficient radiopacity and discoloration potential, alternative materials such as human blood extract and herbal extract have been developed and increasingly used for direct pulp capping procedures. Platelet concentrations have shown a higher volume of dentine bridge formation in vital pulp therapy for adult permanent teeth with reversible pulpitis with a radiographic success rate of 90%. A similar positive response was observed with Acemannan in direct pulp capping procedures of young permanent teeth, with success rates of 72.73% to 77.8%. There is significant variation in the literature regarding the ideal follow-up time for direct pulp capping. The outcome measure, related to pain as shown in the literature is 1 week to 3 months. and for dentine bridge formation, it is 3 to 6 months. The present study evaluates the efficacy of Biodentine, Platelet Rich Fibrin, and Acemannan as direct pulp-capping agents in permanent teeth with carious pulp exposure over a period of 6 months. |