## Protocol Section
### Identification Module
**NCT ID:** NCT06424353

**Brief Title:** Postoperative Pain After Pulpectomy of Primary Molars

**Official Title:** Postoperative Pain After Pulpectomy of Primary Molars Using Two Different Root Canal Obturation Techniques: A Randomized Clinical Trial

#### Organization Study ID Info
**ID:** 87-577
#### Organization
**Class:** OTHER
**Full Name:** Minia University
### Status Module
#### Completion Date
**Date:** 2024-06

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-16

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-05

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-01-20

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Minia University

#### Responsible Party

**Investigator Affiliation:** Minia University

**Investigator Full Name:** Shaimaa Mohamed Abdel Hafeez

**Investigator Title:** postgraduate student at faculty of dentistry

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** Testing postopertive pain after pulpectomy of primary molars with endoflas using modified Wong-Baker scale of pain.

**Detailed Description:** Testing postopertive pain after pulpectomy of primary molars with endoflas using lentilospiral files and pressure seringe by using modified Wong-Baker scale of pain.

### Conditions Module

**Conditions:**

- Postoperative Pain

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- OUTCOMES_ASSESSOR

**Primary Purpose:** OTHER

#### Enrollment Info

**Count:** 100

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Obturation of primary molars with calcium hydroxide, eugenol and iodoform paste using paste carrier files(lentiospiral files)

**Intervention Names:**

- Procedure: Endoflas pulpectomy

**Label:** lentilospiral group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Obturation of primary molars with calcium hydroxide, eugenol and iodoform paste using pressure seringe

**Intervention Names:**

- Procedure: Endoflas pulpectomy

**Label:** pressure seringe group

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- lentilospiral group

- pressure seringe group

**Description:** obturation of root canals of primary molars with Endoflas using pressure seringe and lentilospiral files

**Name:** Endoflas pulpectomy

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** Measuring post operative pain after pulpectomy with two different obturation techniques using (Modified Wong-backer scale of pain )which have four scales from( 0 to 3) which 0 is the better outcome( no pain) and 3 is the worst (severe pain)

**Measure:** postoperative pain

**Time Frame:** after one day and after one week

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* The current study will include children who meet the following clinical and radiographic criteria:

3.1a.Clinical:

1. 5-7-year old children categorized as class I or II according to American Society of Anaesthesiologists (ASA) scale.
2. Children rated as no.3 or 4 in Frankel behavior rating scale (FBRS).
3. Presence of at least one primary molar with deep carious lesion.
4. Asymptomatic necrotic molars confirmed by the absence of bleeding on opening of the pulp chamber.

3.1b. Radiographic:

1. Extensive caries approaching to the pulp.
2. Presence of at least two-thirds of root length.

Exclusion Criteria:

* A child's tooth with any of the following criteria:

3.2a. Clinical findings:

1. History of spontaneous unprovoked toothache.
2. Extensive crown destruction that preclude coronal restoration.
3. Presence of adjacent or opposing tooth with deep carious lesion "in the same side".
4. History of administering analgesics 12 hours before tooth obturation.

3.2b. Radiographic findings:

1. Presence of a large furcation or periapical radiolucency approximating the succedaneous tooth.
2. Presence of pathological internal/external root resorption.
3. Absence of underlying permanent successor.

**Maximum Age:** 7 Years

**Minimum Age:** 5 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** drshimaaalhhafeez93@gmail.com

**Name:** shimaa m abd elhafeez, postgraduate

**Phone:** +0201068976757

**Role:** CONTACT

**Contact 2:**

**Email:** osama.seif@mu.edu.eg

**Name:** Osama s Gad El-Hak, phD

**Phone:** 00201023449797

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Minya

**Contacts:**

***Contact 1:***

- **Email:** drshimaaalhafeez@gmail.com

- **Name:** shimaa m abd elhafeez, postgraduate

- **Phone:** 00201068976757

- **Role:** CONTACT

**Country:** Egypt

**Facility:** Shimaa Mohamed Abd Elhafeez

**Status:** RECRUITING

#### Overall Officials

**Official 1:**

**Affiliation:** Pediatric Dentistry Department, Faculty of Dentistry, Minia University

**Name:** osama s gad elhak, phD

**Role:** STUDY_DIRECTOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000011183

- Term: Postoperative Complications

- ID: D000010335

- Term: Pathologic Processes

- ID: D000010146

- Term: Pain

- ID: D000009461

- Term: Neurologic Manifestations

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC10

- Name: Nervous System Diseases

### Condition Browse Module - Browse Leaves

- ID: M13069

- Name: Pain, Postoperative

- Relevance: HIGH

- As Found: Postoperative Pain

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M14065

- Name: Postoperative Complications

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000010149

- Term: Pain, Postoperative

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: BDCA

- Name: Bone Density Conservation Agents

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: Ot

- Name: Other Dietary Supplements

### Intervention Browse Module - Browse Leaves

- ID: M5381

- Name: Calcium

- Relevance: LOW

- As Found: Unknown

- ID: M5398

- Name: Calcium, Dietary

- Relevance: LOW

- As Found: Unknown

- ID: M8197

- Name: Eugenol

- Relevance: LOW

- As Found: Unknown

- ID: T391

- Name: Eugenol

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
