## Protocol Section
### Identification Module
**NCT ID:** NCT06435065

**Brief Title:** Direct Pulp Capping Agent on Human Pulp Tissue

**Official Title:** Histological and Radiographic Evaluation of the Effects of Direct Pulp Capping Agent on Human Pulp Tissue

#### Organization Study ID Info
**ID:** 2264
#### Organization
**Class:** OTHER
**Full Name:** Maharishi Markendeswar University (Deemed to be University)
### Status Module
#### Completion Date
**Date:** 2024-07

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-23

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-06

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-04-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-17
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** DR SURINDER SACHDEVA

#### Responsible Party

**Investigator Affiliation:** Maharishi Markendeswar University (Deemed to be University)

**Investigator Full Name:** DR SURINDER SACHDEVA

**Investigator Title:** periodontist

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief 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.

**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 Module

**Conditions:**

- Reversible Pulpitis

**Keywords:**

- DIRCT PULP CAPPING

- Biodentine

- MTA

- TheraCal LC

- Tristrontium Aluminate

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 40

**Type:** ESTIMATED

**Phases:**

- PHASE4

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** DIRECT PULP CAPPING WILL BE DONE USING BIODENTINE AS DIRECT PULP CAPPING AGENT

**Intervention Names:**

- Drug: Biodentine

**Label:** BIODENTINE

**Type:** SHAM_COMPARATOR

#### Arm Group 2

**Description:** DIRECT PULP CAPPING WILL BE DONE USING MTA AS DIRECT PULP CAPPING AGENT

**Intervention Names:**

- Drug: Mineral Tri-Oxide Aggregate

**Label:** MINERAL TRIOXIDE AGGREGATE

**Type:** SHAM_COMPARATOR

#### Arm Group 3

**Description:** DIRECT PULP CAPPING WILL BE DONE USING THERACAL LC AS DIRECT PULP CAPPING AGENT

**Intervention Names:**

- Drug: THERACAL LC

**Label:** THERACAL LC

**Type:** SHAM_COMPARATOR

#### Arm Group 4

**Description:** DIRECT PULP CAPPING WILL BE DONE USING TRISTRONTIUM ALUMINATE AS DIRECT PULP CAPPING AGENT

**Intervention Names:**

- Drug: TRISTRONTIUM ALUMINATE

**Label:** TRISTRONTIUM ALUMINATE

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- BIODENTINE

**Description:** DIRECT PULP CAPPINGWILL BE DONE USING BIODENTINE

**Name:** Biodentine

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- MINERAL TRIOXIDE AGGREGATE

**Description:** DIRECT PULP CAPPINGWILL BE DONE USING MTA

**Name:** Mineral Tri-Oxide Aggregate

**Other Names:**

- MTA

**Type:** DRUG

#### Intervention 3

**Arm Group Labels:**

- THERACAL LC

**Description:** DIRECT PULP CAPPINGWILL BE DONE USING THERACAL LC

**Name:** THERACAL LC

**Type:** DRUG

#### Intervention 4

**Arm Group Labels:**

- TRISTRONTIUM ALUMINATE

**Description:** DIRECT PULP CAPPINGWILL BE DONE USING TRISTRONTIUM ALUMINATE

**Name:** TRISTRONTIUM ALUMINATE

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** 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

**Measure:** RADIOGRAPHIC EVALUATION OF FOUR DIRECT PULP CAPPING MATERIALS ON HUMAN PULP TISSUE

**Time Frame:** 90 DAYS

**Description:** Histological examination of the extracted teeth will be done after 90 days and evidence of dentinal bridge formation will be evaluated microscopically

**Measure:** HISTOLOGICAL EVALUATION OF FOUR DIRECT PULP CAPPING MATERIALS ON HUMAN PULP TISSUE

**Time Frame:** 90 DAYS

### Eligibility Module

**Eligibility Criteria:** INCLUSION CRITERIA:

* 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.

EXCLUSION CRITERIA:

* 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
* and/or calcifications in the pulp chamber or canals.
* Medically compromised patient.
* Pregnant patient.

**Healthy Volunteers:** True

**Maximum Age:** 25 Years

**Minimum Age:** 15 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** drswatichhabra@gmail.com

**Name:** swati chhabra, MDS

**Phone:** 7015070095

**Role:** CONTACT

**Contact 2:**

**Email:** navneetkukrejaendo@gmail.com

**Name:** navneet kukreja, MDS

**Phone:** 9416028633

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Ambāla

**Contacts:**

***Contact 1:***

- **Name:** swati chhabra

- **Role:** CONTACT

**Country:** India

**Facility:** Swati

**State:** Haryana

**Status:** RECRUITING

**Zip:** 133207

#### Overall Officials

**Official 1:**

**Affiliation:** professor

**Name:** surinder sachdeva, mds

**Role:** STUDY_DIRECTOR

### References Module

#### References

**Citation:** 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.

**PMID:** 20415913

**Citation:** Nowicka 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.

**PMID:** 23683272

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000003788

- Term: Dental Pulp Diseases

- ID: D000014076

- Term: Tooth Diseases

- ID: D000009057

- Term: Stomatognathic Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC07

- Name: Mouth and Tooth Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M14525

- Name: Pulpitis

- Relevance: HIGH

- As Found: Pulpitis

- ID: M6984

- Name: Dental Pulp Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M16831

- Name: Tooth Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12017

- Name: Stomatognathic Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000011671

- Term: Pulpitis

### Misc Info Module

- Version Holder: 2024-05-31
