## Protocol Section
### Identification Module
**NCT ID:** NCT06418386

**Brief Title:** Bacterial Reduction of Rotary Versus Manual Filing System Using Different Irrigants in Primary Molars

**Official Title:** Clinical Assessment of Antimicrobial Effect of Rotary Versus Manual Filing System Using Different Irrigants in Primary Molars

#### Organization Study ID Info
**ID:** M18060722
#### Organization
**Class:** OTHER
**Full Name:** Mansoura University
### Status Module
#### Completion Date
**Date:** 2024-05-12

**Type:** ACTUAL

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

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-26

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2023-12-15

**Type:** ACTUAL

#### Start Date
**Date:** 2022-09-12

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-17
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-13
**Study First Submit QC Date:** 2024-05-13
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Mansoura University

#### Responsible Party

**Investigator Affiliation:** Mansoura University

**Investigator Full Name:** Menna Mahgoub

**Investigator Title:** principle investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** This study will evaluate and compare the microbial efficacy of rotary and manual filing system using Neem extract, NaOCL and saline . with hypotheses that neem can used alternative to sodium hypochlorite and there is no difference between rotary and manual filling in bacterial reduction.

**Detailed Description:** The calculated sample size of the study will be 22 participants for each group at 5% level of significance and 80 % power 30 participants for each group (10 for The sample size will be increased tocompensate for incomplete data and to increase the study each subgroup) topower

Grouping:

30 child will be selected from the Pediatric Clinic, Faculty of Dentistry, Mansoura University .the child should have 2 contralateral primary molars indicated for pulpectomy. The children will be randomly divided into 2 main groups according to type of file used in root canal preparation: Group I with manual file. Group II with rotary file.

Then the children will be randomly sub grouped according to irrigant that will be used:

Group IA and group II A with normal saline. Group IB and group II B with neem . Group IC and group II C with NaOCl . clinical procedures :

1. Psychological management of child
2. X-ray for inclusion criteria
3. The procedural tooth is anesthetized and isolated with rubber dam. The tooth and adjacent rubber dam will be disinfected with tincture of iodine solution
4. . All carious tissue will be removed by sterilized round bur and root canal access will be done
5. On gaining the access, distal cannel of mandibular primary molars and palatal cannel of maxillary primary molars will be chosen for sampling procedure.
6. A sterile broach will be inserted to obtain root cannel content then sterile paper point inserted to root canal and will be left for 1 min 19 The paper point will be removed with sterilized tweezer which will immediately transferred to tube containing transport medium (eppendrof of containing 200 μl nutrient broth medium).
7. In-group 1 will be prepared with manual files the irrigation with saline in IA, with neem in IB and irrigation with NaOCl in IC.
8. In group II will be prepared with rotary files the irrigation with saline in IIA, with neem in IIB, with NaOCl in IIC
9. The sterile paper point will be introduced into root cannel and will be left for 1 min, the paper point will be removed with sterilized tweezer and then transferred to a tube containing transport medium 19.
10. Post irrigation sample and pre-preparation sample will be transferred to microbiological laboratory.
11. Canals will be filed with obturation material(Metapex)then crown will be restored with glass inomar and stainless steel crown

Laboratory procedures :

1. All samples will be incubated on blood agar aerobically and anaerobically at 37 for 48-72 hours and aspectically streak the plates 19,20.
2. Identification of bacteria by culture characteristics ,microscopic examination and biochemical reaction 21.
3. Number of colony forming unit will be counted (CFU/ml)

### Conditions Module

**Conditions:**

- Necrotic Pulp

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** The children will be randomly divided into 2 main groups according to type of file used in root canal preparation:

Group I with manual file. Group II with rotary file.

Then the children will be randomly sub grouped according to irrigant that will be used:

Group IA and group II A with normal saline. Group IB and group II B with neem . Group IC and group II C with NaOCl

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 30

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** manual k files for pulpectomy and normal saline irrigation

**Intervention Names:**

- Procedure: manual saline IA

**Label:** manual saline

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** manual k files and 100% neem extract

**Intervention Names:**

- Procedure: manual neem IB

**Label:** manual neem extract

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** mannul k files and 1% sodium hypochlorite

**Intervention Names:**

- Procedure: manual sodium hypochlorite IC

**Label:** manual sodium hypochlorite

**Type:** EXPERIMENTAL

#### Arm Group 4

**Description:** AF baby files for pediatric( fanta ) and normal saline

**Intervention Names:**

- Procedure: rotary saline IIA

**Label:** rotary saline

**Type:** EXPERIMENTAL

#### Arm Group 5

**Description:** AF baby files for pediatric( fanta ) and 100% NEEM EXTRACT

**Intervention Names:**

- Procedure: rotary neem IIB

**Label:** rotary neem

**Type:** EXPERIMENTAL

#### Arm Group 6

**Description:** AF baby files for pediatric( fanta ) and 1% sodium hypochloride

**Intervention Names:**

- Procedure: rotary sodoium hypochlorite IIC

**Label:** rotary sodium hypochloride

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- manual saline

**Description:** * The procedural tooth is anesthetized and isolated with rubber dam. The tooth and adjacent rubber dam will be disinfected with tincture of iodine solution, All carious tissue will be removed by hight speed handpiece, distal cannel of mandibular primary molars and palatal cannel of maxillary primary molars will be chosen for sampling procedure.
* A sterile broach will be inserted to obtain root cannel content then sterile paper point inserted to root canal and will be left for 1 min ,The paper point will be removed with sterilized tweezer which will immediately transferred to tube containing transport medium (eppendrof of containing 200 μl nutrient broth medium),using manual k file starting with #15 and irrigation with normal saline
* Post irrigation sample and pre-preparation sample will be transferred to microbiological laboratory Canals will be filed with obturation material(Metapex)then crown will be restored with glass inomar and stainless steel crown

**Name:** manual saline IA

**Type:** PROCEDURE

#### Intervention 2

**Arm Group Labels:**

- manual neem extract

**Description:** * The procedural tooth is anesthetized and isolated with rubber dam. The tooth and adjacent rubber dam will be disinfected with tincture of iodine solution
* . All carious tissue will be removed by high speed hand piece

  , distal cannel of mandibular primary molars and palatal cannel of maxillary primary molars will be chosen for sampling procedure.
* A sterile broach will be inserted to obtain root cannel content then sterile paper point inserted to root canal and will be left for 1 min 19 The paper point will be removed with sterilized tweezer which will immediately transferred to tube containing transport medium (eppendrof of containing 200 μl nutrient broth medium).
* using manual file and irrigation with neem leaf extract 100%
* Post irrigation sample and pre-preparation sample will be transferred to microbiological laboratory Canals will be filed with obturation material(Metapex)then crown will be restored with glass inomar and stainless steel crown

**Name:** manual neem IB

**Type:** PROCEDURE

#### Intervention 3

**Arm Group Labels:**

- manual sodium hypochlorite

**Description:** * adjacent rubber dam will be disinfected with tincture of iodine solution
* . All carious tissue will be removed by hight speed hand piece
* distal cannel of mandibular primary molars and palatal cannel of maxillary primary molars will be chosen for sampling procedure.
* A sterile broach will be inserted to obtain root cannel content then sterile paper point inserted to root canal and will be left for 1 min 19 The paper point will be removed with sterilized tweezer which will immediately transferred to tube containing transport medium (eppendrof of containing 200 μl nutrient broth medium).
* using manual file and irrigation with 1% sodium hypochlorite
* Post irrigation sample and pre-preparation sample will be transferred to microbiological laboratory Canals will be filed with obturation material(Metapex)then crown will be restored with glass inomar and stainless steel crown

**Name:** manual sodium hypochlorite IC

**Type:** PROCEDURE

#### Intervention 4

**Arm Group Labels:**

- rotary saline

**Description:** * shaping and cleaning done with using AF baby fanta files open file:#17 taper 08,then #20 taper 04 ,yellow then #25 taper 04 red , then #30 taper 04 blue . the files activated with torque 2 and speed 350 . Irrigation with normal saline
* Post irrigation sample and pre-preparation sample will be transferred to microbiological laboratory Canals will be filed with obturation material(Metapex)then restored with glass inomar and stainless steel crown

**Name:** rotary saline IIA

**Type:** PROCEDURE

#### Intervention 5

**Arm Group Labels:**

- rotary neem

**Description:** * The procedural tooth is anesthetized and isolated with rubber dam as mentioned
* All carious tissue will be removed by high speed hand piece ,distal cannel of mandibular primary molars and palatal cannel of maxillary primary molars will be chosen for sampling procedure.
* A sterile broach will be inserted to obtain root cannel content then sterile paper point inserted to root canal and will be left for 1 min The paper point will be removed with sterilized tweezer which will immediately transferred to tube containing transport medium (eppendrof of containing 200 μl nutrient broth medium).
* using AF baby fanta files SAME AS METION BEFORE ,and irrigation with 100%neem extract
* Post irrigation sample and pre-preparation sample will be transferred to microbiological laboratory Canals will be filed with obturation material(Metapex)then crown will be restored with glass inomar and stainless steel crown

**Name:** rotary neem IIB

**Type:** PROCEDURE

#### Intervention 6

**Arm Group Labels:**

- rotary sodium hypochloride

**Description:** * The procedural tooth is anesthetized and isolated with rubber dam as mentioned
* All carious tissue will be removed by hight speed hand piece,distal cannel of mandibular primary molars and palatal cannel of maxillary primary molars will be chosen for sampling procedure.
* A sterile broach will be inserted to obtain root cannel content then sterile paper point inserted to root canal and will be left for 1 min The paper point will be removed with sterilized tweezer which will immediately transferred to tube containing transport medium (eppendrof of containing 200 μl nutrient broth medium).
* using AF baby fanta files SAME AS MENTION BEFORE , and irrigation with 1% sodium hypochlorite
* Post irrigation sample and pre-preparation sample will be transferred to microbiological laboratory Canals will be filed with obturation material(Metapex)then crown will be restored with glass inomar and stainless steel crown

**Name:** rotary sodoium hypochlorite IIC

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** number of of colony forming units less the better instrumentation technique and irritant

**Measure:** number of of colony forming units

**Time Frame:** 48 hours after culture

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* age group 4 -8 years.
* good health.
* No recent history of antibiotic coverage for at least two weeks
* necrotic teeth.
* restorable tooth structure.

Exclusion Criteria:

* more than 2/3 resorption of root.
* uncooperative patient.
* detection perforation on radiograph.

**Healthy Volunteers:** True

**Maximum Age:** 8 Years

**Minimum Age:** 4 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Mansoura

**Country:** Egypt

**Facility:** Mansoura University

**Zip:** 35516

#### Overall Officials

**Official 1:**

**Affiliation:** Mansoura University

**Name:** mansoura university

**Role:** STUDY_CHAIR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**Citation:** Susila AV, Sai S, Sharma N, Balasubramaniam A, Veronica AK, Nivedhitha S. Can natural irrigants replace sodium hypochlorite? A systematic review. Clin Oral Investig. 2023 May;27(5):1831-1849. doi: 10.1007/s00784-023-04913-7. Epub 2023 Feb 18.

**PMID:** 36808559

**Citation:** Sundaram D, Narayanan RK, Vadakkepurayil K. A Comparative Evaluation on Antimicrobial Effect of Honey, Neem Leaf Extract and Sodium Hypochlorite as Intracanal Irrigant: An Ex-Vivo Study. J Clin Diagn Res. 2016 Aug;10(8):ZC88-91. doi: 10.7860/JCDR/2016/19268.8311. Epub 2016 Aug 1.

**PMID:** 27656571

**Citation:** Lakshmanan L, Jeevanandan G. Microbial Evaluation of Root Canals after Biomechanical Preparation with Manual K-files, Manual H-files, and Kedo-SG Blue Rotary Files: An In Vivo Study. Int J Clin Pediatr Dent. 2022 Nov-Dec;15(6):687-690. doi: 10.5005/jp-journals-10005-2457.

**PMID:** 36866149

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009336

- Term: Necrosis

- ID: D000010335

- Term: Pathologic Processes

- ID: D000003788

- Term: Dental Pulp Diseases

- ID: D000014076

- Term: Tooth Diseases

- ID: D000009057

- Term: Stomatognathic Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC07

- Name: Mouth and Tooth Diseases

### Condition Browse Module - Browse Leaves

- ID: M12284

- Name: Necrosis

- Relevance: LOW

- As Found: Unknown

- ID: M6986

- Name: Dental Pulp Necrosis

- Relevance: HIGH

- As Found: Necrotic Pulp

- 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: D000003790

- Term: Dental Pulp Necrosis

### 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: PhSol

- Name: Pharmaceutical Solutions

- Abbrev: Micro

- Name: Micronutrients

- Abbrev: HB

- Name: Herbal and Botanical

### Intervention Browse Module - Browse Leaves

- ID: M4222

- Name: Anti-Bacterial Agents

- Relevance: LOW

- As Found: Unknown

- ID: M15775

- Name: Sodium Hypochlorite

- Relevance: HIGH

- As Found: Cash

- ID: M44557

- Name: Eusol

- Relevance: HIGH

- As Found: Cash

- ID: M21860

- Name: Pharmaceutical Solutions

- Relevance: LOW

- As Found: Unknown

- ID: M4214

- Name: Anti-Infective Agents

- Relevance: LOW

- As Found: Unknown

- ID: M10488

- Name: Iodine

- Relevance: LOW

- As Found: Unknown

- ID: M229695

- Name: Cadexomer iodine

- Relevance: LOW

- As Found: Unknown

- ID: M7383

- Name: Disinfectants

- Relevance: LOW

- As Found: Unknown

- ID: T237

- Name: Neem

- Relevance: HIGH

- As Found: Tissue regeneration

### Intervention Browse Module - Meshes

- ID: D000012973

- Term: Sodium Hypochlorite

- ID: C000024611

- Term: Eusol

### Misc Info Module

- Version Holder: 2024-05-31
