## Protocol Section
### Identification Module
**NCT ID:** NCT06433245

**Brief Title:** Outcome Following Use of Different Concentrations of NaOCl as Wound Lavage and Hemostatic Agent in Partial Pulpotomy

**Official Title:** Outcome Following Use of Different Concentrations of Sodium Hypochlorite as Wound Lavage and Hemostatic Agent in Partial Pulpotomy: A Randomised Control Trial

#### Organization Study ID Info
**ID:** Ridhi Karwal
#### Organization
**Class:** OTHER
**Full Name:** Postgraduate Institute of Dental Sciences Rohtak
### Status Module
#### Completion Date
**Date:** 2025-12-23

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-22

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-12-23

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-23

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-22
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Postgraduate Institute of Dental Sciences Rohtak

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The aim of this randomised control trial is to compare the effect of different concentrations of NaOCl on outcome of partial pulpotomy in teeth with clinical signs indicative of irreversible pulpitis.

The main question it aims to answer are:

1. clinical and radiographic outcome of partial pulpotomy following use of 5% and 3% NaOCl in mature permanent teeth with clinical signs indicative of irreversible pulpitis.
2. OHRQoL and pain experience after use of 5% and 3% NaOCl during partial pulpotomy in teeth with clinical signs indicative of irreversible pulpitis.

**Detailed Description:** TITLE :- Outcome following use of different concentrations of NaOCl as wound lavage and hemostatic agent in partial pulpotomy: A Randomised control trial.

Question it aims to answer:

Does pulpal lavage using 3% and 5% sodium hypochlorite have comparable effect on outcome of partial pulpotomy in mature permanent teeth with clinical signs of irreversible pulpitis? P (Population) -Mature permanent mandibular molars with signs of irreversible pulpitis.

I (Intervention) - 5% NaOCl C (Comparison) - 3% NaOCl O (Outcome) - 1. Assessment of clinical and radiographic success at 12 months of follow up.

2. Assessment of OHRQoL and pain experience at baseline, post-operatively every 24 hours for 1 week and OHRQoL at 6 and 12 months.

In literature pertaining to vital pulp therapy procedures, there is often a focus on comparing various materials or treatment methodologies. However, the use of sodium hypochlorite, holds significant importance in ensuring the successful outcome of the procedure. The previous studies indicate that the use of NaOCl presents as a confounding factor, compounded by variations among operators in their choice of high and low concentrations of NaOCl.So, there is a pressing need for a direct comparative analysis to assess the influence of varying sodium hypochlorite concentrations on the overall efficacy and success rates of vital pulp therapy procedures.

### Conditions Module

**Conditions:**

- Irreversible Pulpitis

- Extremely Deep Caries

- Partial Pulpotomy

**Keywords:**

- partial pulpotomy

- sodium hypochlorite

- mature permanent mandibular molars

- hemostatic agent

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** QUADRUPLE

**Masking Description:** The operator, patient and the outcome assessor will be masked to the group allocation

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 116

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** After partial pulpotomy procedure, pulp wound will be irrigated with 3% sodium hypochlorite and haemostasis will be achieved by placing the cotton pellet soaked with 3% sodium hypochlorite on the amputated pulp.

**Intervention Names:**

- Procedure: effect of 3% and 5% sodium hypochlorite on outcome of partial pulpotomy in teeth with clinical signs indicative of irreversible pulpitis.

**Label:** Control: 3% sodium hypochlorite

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** After partial pulpotomy procedure, pulp wound will be irrigated with 5% sodium hypochlorite and haemostasis will be achieved by placing the cotton pellet soaked with 5% sodium hypochlorite on the amputated pulp.

**Intervention Names:**

- Procedure: effect of 3% and 5% sodium hypochlorite on outcome of partial pulpotomy in teeth with clinical signs indicative of irreversible pulpitis.

**Label:** Test: 5% sodium hypochlorite

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Control: 3% sodium hypochlorite

- Test: 5% sodium hypochlorite

**Description:** After caries removal and pulp exposure pulp tissue is amputated and hemostasis is achieved with 3% sodium hypochlorite in control group and 5% sodium hypochlorite in experimental group followed by capping with 2-3mm layer of MTA. A layer of RMGIC will be placed over the MTA. Then the tooth will be permanently restored with composite resin.

**Name:** effect of 3% and 5% sodium hypochlorite on outcome of partial pulpotomy in teeth with clinical signs indicative of irreversible pulpitis.

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** Clinical criteria of success:-

1. No pain or discomfort except for the first few days after treatment.
2. No tenderness to palpation or percussion and the tooth is functional.
3. Normal mobility and probing pocket depth.
4. Healthy soft tissues around teeth with no swelling, sinus tract.

**Measure:** Clinical success rate

**Time Frame:** baseline to 12 months

**Description:** Radiographic success criteria:-

1. No pathosis such as root resorption, furcal pathosis or new periapical pathosis evident on the radiograph.
2. Complete radiographic healing

**Measure:** Radiographic success rate

**Time Frame:** Baseline to 12 months

#### Secondary Outcomes

**Description:** To assess incidence and intensity of pain postoperatively at every 24 hours till 7 days using Visual analogue Scale of 0 to 100 millimeter line. Score 0 means no pain and Score100 means maximum pain. To assess incidence and intensity of pain postoperatively at every 24 hours till 7 days using Visual analogue Scale of 0 to 100 millimeter line. Score 0 means no pain and Score 100 means maximum pain

**Measure:** Post Operative Pain

**Time Frame:** Baseline to 7 days

**Description:** OHIP-14 questionnare will be used to assess the quality of life.It consists of questionnaire in seven dimensions: functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability, and handicap. It will be scored using a Lickert scale:

never=0; hardly ever=1; occasionally=2; fairly often=3; very often=4. Total score will be calculated ranging from 0-56, with higher score denoting the worst OHRQoL

**Measure:** OHRQoL assessment

**Time Frame:** baseline and at 24 h, 2, 3, 4, 5, 6 and 7 days after the treatment, and then at 6 and 12 months.

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Mature permanent mandibular molars.
2. Teeth with clinical diagnosis of symptomatic irreversible pulpitis
3. Patients having normal periapical status with periapical index (PAI) score ≤ 2
4. Periodontally healthy teeth
5. Patients having physical status of class 1 or 2 according to ASA classification
6. Pulpal bleeding can be controlled within 6 minutes.
7. Presence of extremely deep carious lesion on radiograph -

Exclusion Criteria:

1) Non restorable teeth 2) Necrotic pulp evident upon exposure 3) Negative response to vitality test 4) Presence of sinus tract 5) Presence of soft tissue swelling 6) Radiographic signs of internal or external root resorption 7) Pregnant women

-

**Healthy Volunteers:** True

**Maximum Age:** 40 Years

**Minimum Age:** 15 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** drps_1@yahoo.co.in

**Name:** Dr. Pankaj Sangwan, MDS

**Phone:** 9996112202

**Role:** CONTACT

**Contact 2:**

**Email:** ridhikarwal56@mail.com

**Name:** Ridhi Karwal, MDS

**Phone:** 9958430414

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Rohtak

**Contacts:**

***Contact 1:***

- **Email:** drps_1@yahoo.co.in

- **Name:** DR. Pankaj Sangwan, MDS

- **Phone:** 9996112202

- **Role:** CONTACT

***Contact 2:***

- **Email:** principalpgids@yahoo.in

- **Name:** : DR. Sanjay TewarI, MDS

- **Phone:** 9416259534

- **Role:** CONTACT

**Country:** India

**Facility:** PIGDS

**State:** Haryana

**Status:** RECRUITING

**Zip:** 124001

#### Overall Officials

**Official 1:**

**Affiliation:** PGIDS, Rohtak, Haryana 124001

**Name:** Dr. Sanjay Tewari, MDS

**Role:** STUDY_DIRECTOR

## 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: BC26

- Name: Wounds and Injuries

- Abbrev: All

- Name: All Conditions

- Abbrev: BC07

- Name: Mouth and Tooth Diseases

### Condition Browse Module - Browse Leaves

- ID: M17685

- Name: Wounds and Injuries

- Relevance: LOW

- As Found: Unknown

- 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

### Intervention Browse Module - Ancestors

- ID: D000004202

- Term: Disinfectants

- ID: D000000890

- Term: Anti-Infective Agents

### Intervention Browse Module - Browse Branches

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Coag

- Name: Coagulants

### Intervention Browse Module - Browse Leaves

- ID: M15775

- Name: Sodium Hypochlorite

- Relevance: HIGH

- As Found: Cash

- ID: M44557

- Name: Eusol

- Relevance: HIGH

- As Found: Cash

- ID: M9576

- Name: Hemostatics

- Relevance: LOW

- As Found: Unknown

- ID: M7383

- Name: Disinfectants

- Relevance: LOW

- As Found: Unknown

- ID: M4214

- Name: Anti-Infective Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000012973

- Term: Sodium Hypochlorite

- ID: C000024611

- Term: Eusol

### Misc Info Module

- Version Holder: 2024-05-31
