Reversible PulpitisPhase 4NCT06435065
Direct Pulp Capping Agent on Human Pulp Tissue
A Phase 4 study testing Biodentine, Mineral Tri-Oxide Aggregate and THERACAL LC in people with Reversible Pulpitis, run by DR SURINDER SACHDEVA at 1 site in India.
Trial summary
This in- vivo study was conducted to evaluate the response of human pulp tissue following direct pulp capping using four different pulp capping agents in premolars scheduled for extraction in patients undergoing orthodontic treatment. Read more about this study
- Who is it for?
- Ages 15 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Reversible Pulpitis
- What is being tested?
- Biodentine, Mineral Tri-Oxide Aggregate and THERACAL LC
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteIndia
- Study dates
- 28 Apr 2024to 30 Nov 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- CARIES-free, undamaged mature maxillary and mandibular premolars that were planned for extraction for orthodontic reasons.
- Teeth that show no reaction to percussion.
- Teeth with no previous restorations.
- Teeth that show vitality, when checked with an electric pulp tester.
- Teeth that show no signs of caries or periapical pathology when examined
- radiographically.
- Fully erupted teeth, that allowed proper application of rubber dam.
Who cannot join
- caries are present
- Teeth with signs and symptoms of irreversible pulpitis, such as nighttime severe pain
- or spontaneous pain.
- Teeth that show sensitivity to hot and/or cold.
- Radiographic examination reveals any signs of caries, periapical pathology,
- internal/external root resorption, furcal radiolucency/ inter-radicular bone destruction
Show all 9Show fewer
- and/or calcifications in the pulp chamber or canals.
- Medically compromised patient.
- Pregnant patient.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Histological and Radiographic Evaluation of the Effects of Direct Pulp Capping Agent on Human Pulp Tissue
This in- vivo study was conducted to evaluate the response of human pulp tissue following direct pulp capping using four different pulp capping agents in premolars scheduled for extraction in patients undergoing orthodontic treatment.
Read the detailed description
For the study 40 premolars from patients in the age group of 15-25 years, undergoing orthodontic treatment, in the Department of Orthodontics, MMCDSR, Mullana, Ambala, who had to get their premolars extracted as per their orthodontic treatment plan will be selected.
Only healthy premolars, with no caries, showing no signs and symptoms of pulpitis or periodontal diseases were selected. Medically compromised patients, or teeth with radiographic findings of external/internal resorption, bone loss, or calcifications in the pulp chamber will be excluded from the study. The selected premolars were then randomly divided into four equal groups namely: GROUP I - Direct pulp capping procedure performed using Biodentine. GROUP II - Direct pulp capping procedure performed using MTA. GROUP III - Direct pulp capping procedure performed using TheraCal LC. GROUP IV - Direct pulp capping procedure performed using Tristrontium aluminate.
The direct pulp capping procedure was carried out under rubber dam. The study protocol included class I cavity preparations on the premolars, followed by iatrogenic exposure of the pulp (0.5mm) using a sterile round bur, placement of the direct pulp capping agent according to the material of allotted to the study group. The teeth were permanently restored on the same visit, except for MTA group were the teeth were temporarily restored using Cavit G, and recalled after 1 day for permanent restoration. The patients were then enquired for any 94 SUMMARY 95 symptoms at 1 day and 7 days post operatively. The teeth were then, atraumatically extracted 3 months after the procedure. The extracted teeth were then put to CBCT as well as histopathological examination. Through CBCT evaluation, the completeness of the dentine bridge was evaluated. Histopathological examination was done to examine the pulpal response and the quality of the dentine bridge formed
- Conditions
- Reversible Pulpitis
- Being tested
- Biodentine, Mineral Tri-Oxide Aggregate, THERACAL LC, TRISTRONTIUM ALUMINATE
- Keywords
- DIRCT PULP CAPPING, Biodentine, MTA, TheraCal LC, Tristrontium Aluminate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiodentineDrug
DIRECT PULP CAPPINGWILL BE DONE USING BIODENTINE
Mineral Tri-Oxide AggregateDrug
Also called MTA
DIRECT PULP CAPPINGWILL BE DONE USING MTA
THERACAL LCDrug
DIRECT PULP CAPPINGWILL BE DONE USING THERACAL LC
TRISTRONTIUM ALUMINATEDrug
DIRECT PULP CAPPINGWILL BE DONE USING TRISTRONTIUM ALUMINATE
| Study group | Role | What they receive |
|---|---|---|
| BIODENTINE | Sham comparator | DIRECT PULP CAPPING WILL BE DONE USING BIODENTINE AS DIRECT PULP CAPPING AGENT Receives: Drug: Biodentine |
| MINERAL TRIOXIDE AGGREGATE | Sham comparator | DIRECT PULP CAPPING WILL BE DONE USING MTA AS DIRECT PULP CAPPING AGENT Receives: Drug: Mineral Tri-Oxide Aggregate |
| THERACAL LC | Sham comparator | DIRECT PULP CAPPING WILL BE DONE USING THERACAL LC AS DIRECT PULP CAPPING AGENT Receives: Drug: THERACAL LC |
| TRISTRONTIUM ALUMINATE | Active comparator | DIRECT PULP CAPPING WILL BE DONE USING TRISTRONTIUM ALUMINATE AS DIRECT PULP CAPPING AGENT Receives: Drug: TRISTRONTIUM ALUMINATE |
What is being measured
The primary outcome is the main question the study is designed to answer.
RADIOGRAPHIC EVALUATION OF FOUR DIRECT PULP CAPPING MATERIALS ON HUMAN PULP TISSUE
radiographic examination will be done after 90 days and presence or absence of secondary dentin formation and completeness of the dentinal bride formed will be evaluated by CBCT
Measured: 90 DAYS
HISTOLOGICAL EVALUATION OF FOUR DIRECT PULP CAPPING MATERIALS ON HUMAN PULP TISSUE
Histological examination of the extracted teeth will be done after 90 days and evidence of dentinal bridge formation will be evaluated microscopically
Measured: 90 DAYS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2024
- Study start28 Apr 2024
- Primary completion30 Apr 2025
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Reversible PulpitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- DR SURINDER SACHDEVA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, DR SURINDER SACHDEVA, Maharishi Markendeswar University (Deemed to be University)
- Investigators
- surinder sachdeva, mds, Study director, professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06435065
- Sponsor's protocol ID
- 2264
- Status last verified
- May 2024
- First submitted
- 17 May 2024
- Last updated
- 8 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Parolia A, Kundabala M, Rao NN, Acharya SR, Agrawal P, Mohan M, Thomas M. A comparative histological analysis of human pulp following direct pulp capping with Propolis, mineral trioxide aggregate and Dycal. Aust Dent J. 2010 Mar;55(1):59-64. doi: 10.1111/j.1834-7819.2009.01179.x.
PubMed 20415913Nowicka A, Lipski M, Parafiniuk M, Sporniak-Tutak K, Lichota D, Kosierkiewicz A, Kaczmarek W, Buczkowska-Radlinska J. Response of human dental pulp capped with biodentine and mineral trioxide aggregate. J Endod. 2013 Jun;39(6):743-7. doi: 10.1016/j.joen.2013.01.005. Epub 2013 Apr 10.
PubMed 23683272
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Histological and Radiographic Evaluation of the Effects of Direct Pulp Capping Agent on Human Pulp Tissue
- ClinicalTrials.gov ID
- NCT06435065
- Acronym / sponsor ID
- 2264
- Conditions
- Reversible Pulpitis
- Keywords
- DIRCT PULP CAPPING, Biodentine, MTA, TheraCal LC, Tristrontium Aluminate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- DR SURINDER SACHDEVAUniversity, hospital or other
- Study start
- 28 Apr 2024 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 30 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This in- vivo study was conducted to evaluate the response of human pulp tissue following direct pulp capping using four different pulp capping agents in premolars scheduled for extraction in patients undergoing orthodontic treatment.
Detailed description
For the study 40 premolars from patients in the age group of 15-25 years, undergoing orthodontic treatment, in the Department of Orthodontics, MMCDSR, Mullana, Ambala, who had to get their premolars extracted as per their orthodontic treatment plan will be selected.
Only healthy premolars, with no caries, showing no signs and symptoms of pulpitis or periodontal diseases were selected. Medically compromised patients, or teeth with radiographic findings of external/internal resorption, bone loss, or calcifications in the pulp chamber will be excluded from the study. The selected premolars were then randomly divided into four equal groups namely: GROUP I - Direct pulp capping procedure performed using Biodentine. GROUP II - Direct pulp capping procedure performed using MTA. GROUP III - Direct pulp capping procedure performed using TheraCal LC. GROUP IV - Direct pulp capping procedure performed using Tristrontium aluminate.
The direct pulp capping procedure was carried out under rubber dam. The study protocol included class I cavity preparations on the premolars, followed by iatrogenic exposure of the pulp (0.5mm) using a sterile round bur, placement of the direct pulp capping agent according to the material of allotted to the study group. The teeth were permanently restored on the same visit, except for MTA group were the teeth were temporarily restored using Cavit G, and recalled after 1 day for permanent restoration. The patients were then enquired for any 94 SUMMARY 95 symptoms at 1 day and 7 days post operatively. The teeth were then, atraumatically extracted 3 months after the procedure. The extracted teeth were then put to CBCT as well as histopathological examination. Through CBCT evaluation, the completeness of the dentine bridge was evaluated. Histopathological examination was done to examine the pulpal response and the quality of the dentine bridge formed
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| BIODENTINE | Sham comparator | Drug: BiodentineDIRECT PULP CAPPING WILL BE DONE USING BIODENTINE AS DIRECT PULP CAPPING AGENT |
| MINERAL TRIOXIDE AGGREGATE | Sham comparator | Drug: Mineral Tri-Oxide AggregateDIRECT PULP CAPPING WILL BE DONE USING MTA AS DIRECT PULP CAPPING AGENT |
| THERACAL LC | Sham comparator | Drug: THERACAL LCDIRECT PULP CAPPING WILL BE DONE USING THERACAL LC AS DIRECT PULP CAPPING AGENT |
| TRISTRONTIUM ALUMINATE | Active comparator | Drug: TRISTRONTIUM ALUMINATEDIRECT PULP CAPPING WILL BE DONE USING TRISTRONTIUM ALUMINATE AS DIRECT PULP CAPPING AGENT |
Who may qualify
- Ages
- 15 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- CARIES-free, undamaged mature maxillary and mandibular premolars that were planned for extraction for orthodontic reasons.
- Teeth that show no reaction to percussion.
- Teeth with no previous restorations.
- Teeth that show vitality, when checked with an electric pulp tester.
- Teeth that show no signs of caries or periapical pathology when examined
Key exclusion criteria (9 listed)
- caries are present
- Teeth with signs and symptoms of irreversible pulpitis, such as nighttime severe pain
- or spontaneous pain.
- Teeth that show sensitivity to hot and/or cold.
- Radiographic examination reveals any signs of caries, periapical pathology,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BiodentineDIRECT PULP CAPPINGWILL BE DONE USING BIODENTINE | Drug | BIODENTINE |
| Mineral Tri-Oxide AggregateAlso: MTADIRECT PULP CAPPINGWILL BE DONE USING MTA | Drug | MINERAL TRIOXIDE AGGREGATE |
| THERACAL LCDIRECT PULP CAPPINGWILL BE DONE USING THERACAL LC | Drug | THERACAL LC |
| TRISTRONTIUM ALUMINATEDIRECT PULP CAPPINGWILL BE DONE USING TRISTRONTIUM ALUMINATE | Drug | TRISTRONTIUM ALUMINATE |
Primary outcome
RADIOGRAPHIC EVALUATION OF FOUR DIRECT PULP CAPPING MATERIALS ON HUMAN PULP TISSUE
Time frame: 90 DAYS
radiographic examination will be done after 90 days and presence or absence of secondary dentin formation and completeness of the dentinal bride formed will be evaluated by CBCT
HISTOLOGICAL EVALUATION OF FOUR DIRECT PULP CAPPING MATERIALS ON HUMAN PULP TISSUE
Time frame: 90 DAYS
Histological examination of the extracted teeth will be done after 90 days and evidence of dentinal bridge formation will be evaluated microscopically
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Background: PubMed 20415913Parolia A, Kundabala M, Rao NN, Acharya SR, Agrawal P, Mohan M, Thomas M. A comparative histological analysis of human pulp following direct pulp capping with Propolis, mineral trioxide aggregate and Dycal. Aust Dent J. 2010 Mar;55(1):59-64. doi: 10.1111/j.1834-7819.2009.01179.x.
- Background: PubMed 23683272Nowicka A, Lipski M, Parafiniuk M, Sporniak-Tutak K, Lichota D, Kosierkiewicz A, Kaczmarek W, Buczkowska-Radlinska J. Response of human dental pulp capped with biodentine and mineral trioxide aggregate. J Endod. 2013 Jun;39(6):743-7. doi: 10.1016/j.joen.2013.01.005. Epub 2013 Apr 10.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
surinder sachdeva, mds study director
professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Biodentine, Mineral Tri-Oxide Aggregate and THERACAL LC in people with Reversible Pulpitis, run by DR SURINDER SACHDEVA at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RADIOGRAPHIC EVALUATION OF FOUR DIRECT PULP CAPPING MATERIALS ON HUMAN PULP TISSUE (time frame: 90 DAYS). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06435065, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.