| CTRI Number |
CTRI/2025/08/093432 [Registered on: 21/08/2025] Trial Registered Prospectively |
| Last Modified On: |
21/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparative evaluation of MTA, Biodentine and TheraCal LC in vital pulp therapy of permanent molars with symptomatic pulpitis: An In Vivo Study |
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Scientific Title of Study
|
Comparative Evaluation of Mineral Trioxide Aggregate, Biodentine and TheraCal LC In Vital Pulp Therapy In Management Of Permanent Molars With Symptomatic Pulpitis: An In-vivo Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
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| Secondary ID |
Identifier |
| NIL |
NIL |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Prashant Srivastava |
| Designation |
Post-graduate student |
| Affiliation |
HKES S.NIjalingappa Institute of Dental Sciences and Research |
| Address |
HKES S.NIjalingappa Institute of Dental Sciences and Research,Sedam road,Rajapur Colony,Kalaburagi (Gulbarga)
Gulbarga KARNATAKA 585105 India |
| Phone |
8660375164 |
| Fax |
|
| Email |
drprincemra@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Ratnakar P |
| Designation |
Professor |
| Affiliation |
HKES S.NIjalingappa Institute of Dental Sciences and Research |
| Address |
Dept. of Conservative Dentistry & Endodontics
HKES S.Nijalingappa Institute of Dental Sciences and Research,Sedam road,Rajapur Colony,Kalaburagi (Gulbarga)
Gulbarga KARNATAKA 585105 India |
| Phone |
9866599960 |
| Fax |
|
| Email |
dr.ratnakarchoudary@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Prashant Srivastava |
| Designation |
Post-graduate student |
| Affiliation |
HKES S.Nijalingappa Institute of Dental Sciences and Research |
| Address |
Dept. of Conservative Dentistry & Endodontics
HKES S.Nijalingappa Institute of Dental Sciences and Research,Sedam road,Rajapur Colony,Kalaburagi (Gulbarga)
Gulbarga KARNATAKA 585105 India |
| Phone |
8660375164 |
| Fax |
|
| Email |
drprincemra@gmail.com |
|
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Source of Monetary or Material Support
|
| HKES S.Nijalingappa Institute of Dental Sciences and Research, Kalaburagi |
|
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Primary Sponsor
|
| Name |
Dr. Prashant Srivastava |
| Address |
HKES S.Nijalingappa Institute of Dental Sciences and Research, Sedam Road, Kalauragi, Karnataka-585105 |
| Type of Sponsor |
Other [Individual (Self)] |
|
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Prashant Srivastava |
HKESs S Nijalingappa Institute of Dental Sciences and Research Kalaburagi |
Room number 4 Department of Conservative Dentistry and Endodontics Gulbarga KARNATAKA |
8660375164
drprincemra@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| S Nijalingappa Institute of Dental Sciences and Research Institutional Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: K029||Dental caries, unspecified, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Progression of Caries |
Permanent Molars with Symptomatic Pulpitis will be intervened as per the status of pulp involvement for 6 months |
| Comparator Agent |
Vital Pulp Therapy Agent |
MTA, Biodentine, Theracal LC for 6 months |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Systemically healthy patients (Category: ASA 1) aged between 18-50 years diagnosed with symptomatic or asymptomatic reversible or irreversible pulpitis on a permanent molar teeth.
2.Caries extending to inner dentin(3rd or quarter)
3.Periodontially healthy patient
4.Tooth without clinical/radiographic sign of apical periodontitis.
5.The teeth that respond positively to electric pulp test as well as to cold tests
|
|
| ExclusionCriteria |
| Details |
1.Teeth with crown/root fractures, acute or chronic apical abscess, compromised periodontium, and open apex will be excluded.
2.Teeth exhibiting signs and symptoms of chronic irritation such as swelling, mobility, sinus tract.
3.Radiographic evidence of pathologic root resorption, inter-radicular bone loss, calcification in canal and periapical cysts.
4.Teeth which will be observed to be non-vital on cavity preparation shall be excluded
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Method of Generating Random Sequence
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Other |
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Method of Concealment
|
Other |
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Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
| Clinically assessment of the efficacy of Vital Pulp therapy using MTA, Biodentine and Theracal LC will be assessed |
1 month, 3 months and 6 months |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Determination and comparison of the degree of reparative dentine formation after receiving vital pulp therapy with diverse materials. |
Determination and comparison of the degree of reparative dentine formation after 1 month, 3 months, 6 months |
|
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Target Sample Size
|
Total Sample Size="90" Sample Size from India="90"
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)
|
01/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/09/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
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Brief Summary
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|
· Pulp vitality is an important aspect in determining a tooth’s long-term
health and survival, as exposed vital pulp has an intrinsic capacity for
healing. By eliminating contaminated tissue and promoting dentin bridge
formation with a minimally invasive approach: Vital Pulp Therapy works to
preserve and protect the pulpal vitality of a tooth that has undergone
mutilating factors such as dental caries, trauma, and operative failure,
especially when pulp inflammation is limited to the outermost layers and the
deeper layers are healthy. Although root canal therapy is well recognized to
produce reliable results, it leaves teeth prone to fracture, and it would be
preferable to provide patients with an alternative minimal invasive approach.
Hence the argument for vital pulp therapy is that radicular pulp tissue is
healthy or capable of recovering after surgical amputation of the damaged or
contaminated coronal pulp.1,2,3
·
Direct pulp capping, which includes
applying a protective pulp capping material directly over the exposure
location, is typically indicated in a recent exposure of pulp that is
pinpoint-sized. Indirect pulp capping is a treatment in which
non-mineralizable carious tissue is removed, leaving a thin layer of
remaining sound dentin at the deepest site of the cavity to prevent pulp
exposure and the caries affected dentin is capped with suitable biocompatible
material. In contrast, pulpotomy is described as the partial removal of the
pulp (coronal component) while keeping the radicular pulp intact after
establishing adequate hemostasis and restoration done with biocompatible
materials.4,5
|
Since
diagnosis is a crucial component of treatment planning in endodontics, dental
pulp testing is an important and indispensable diagnostic tool. Sensory nerves
of different sizes are significantly affected by changes in intra-pulpal
pressure; when pressure levels rise, larger diameter A-delta fibers are mostly
blocked and smaller diameter C-fibers are activated. C-fibers may continue to
function even if the pulp degenerates as a result of the underlying
disease because they are more resistant to hypoxia. The most commonly used pulp
sensibility tests are thermal and electrical tests that stimulate the pulpal
nerves either by conducting an electrical current through the tooth, which
causes the odontoblast processes to move and subsequently mechanically stimulate
the pulpal nerves, or with dentinal fluid displacement at temperature variations.
|
· Despite recent technological advancements in dental materials, like
improved biocompatibility, regenerative dentin capacity, bioactivity, fast
setting time and decreased solubility, there still remains a quest for the
perfect vital pulp therapy agent. Furthermore, research is currently ongoing in order to achieve the
greatest possible clinical and radiographic success in permanent dentitions and
the demand for better medications has opened the door for more clinical
investigations to explore the effectiveness rate of Vital Pulp Therapy (VPT)
in teeth using various protocols.7,8
· Mineral Trioxide Aggregate (MTA) is a calcium silicate-based cement,
developed by Torabinejad that has been
extensively researched and reported to provide high success rates(~90%) of
treatment outcomes in vital pulp therapy .It is composed of portland cement
(75%), bismuth oxide (20%) and gypsum
(5%). Portland cement is a combination of tricalcium silicate, dicalcium
silicate, tricalium aluminate & tetracalciumaluminoferrite. In comparison
to calcium oxide, it has many advantages including a homogenous dentinal
bridge formation with fewer tunnel defects, sustained calcium release,
biocompatibility, sealing ability, long-term stability, low solubility,
hygroscopic nature, excellent sealing ability, solubilization of bioactive
proteins, and ability for tissue remineralization. Although MTA has a greater
success rate, the disadvantages of this material, including its high cost, technique
sensitivity, longer setting time, potential for tooth discoloration and
inclusion of poisonous heavy metals, have led researchers to hunt for other
materials. Yet numerous studies have used MTA as a gold standard medicament
in vital pulp therapy.9,10
·
Biodentine, a bioactive dentine substitute,
composed of Tricalcium Silicate(80%), with Zirconium oxide as a radio-opacifier,
calcium carbonate(15%) as a filler and water as setting accelerator of
Calcium Chloride. It has been reported to have superior mechanical properties
like better color stability, easier handling and manipulation and fast
setting time. Its major drawbacks are low radioopacity and difficulty in
maintaining a specific consistency.9,10,11,12
|
Theracal
LC (Bisco,USA) was introduced to address the lack of adhesion between the
resins and calcium silicate based materials in final restorations. Theracal LC
is a calcium silicate filled, light-cured liner which provides an insulative
and protective layer for pulp-dentin complex. Theracal LC releases calcium which enhances development of hydroxyapatite which in turn forms dentine bridge. It has superior bonding capacity compared to composite and glass-ionomer cement with a significant bioactivity.Additional research is required to estimate its efficacy over a longer period of time. The newly developed materials have the ability to stimulate the pulp progenitor cells in an improved manner and there is ever growing demand for new developments of bioactive materials for Vital pulp Therapy (VPT). However, their long term success in permanent teeth still needs to be supported by further research.
|
There
have been studies which have been conducted in- vitro and most of them are in
primary dentition. However, there are quite limited In-Vivo studies
and case reports which have been done on Permanent
teeth to substantiate the effects of MTA, Biodentine and Theracal LC and
compare their clinical efficacy and radiographical analysis in contrast with
each other under different vital pulp therapy procedures.The purpose of this study is to
provide comparison between these bioactive materials of choice in Vital Pulp
Therapy in treatment of permanent teeth with symptomatic pulpitis.
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