Bacterial Reduction of Rotary Versus Manual Filing System Using Different Irrigants in Primary Molars

NCT06418386 | Completed DMC

• 1 other identifier: M18060722
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Necrotic Pulp

Outcome Measures

Primary Outcomes (1)

• number of of colony forming units

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

  48 hours after culture

Study Arms (6)

manual saline

ACTIVE COMPARATOR

manual k files for pulpectomy and normal saline irrigation

Procedure: manual saline IA

manual neem extract

EXPERIMENTAL

manual k files and 100% neem extract

Procedure: manual neem IB

manual sodium hypochlorite

EXPERIMENTAL

mannul k files and 1% sodium hypochlorite

Procedure: manual sodium hypochlorite IC

rotary saline

EXPERIMENTAL

AF baby files for pediatric( fanta ) and normal saline

Procedure: rotary saline IIA

rotary neem

EXPERIMENTAL

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

Procedure: rotary neem IIB

rotary sodium hypochloride

EXPERIMENTAL

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

Procedure: rotary sodoium hypochlorite IIC

Interventions

manual saline IA PROCEDURE

* 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

manual saline

manual neem IB PROCEDURE

* 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

manual neem extract

manual sodium hypochlorite IC PROCEDURE

* 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

manual sodium hypochlorite

rotary saline IIA PROCEDURE

* 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

rotary saline

rotary neem IIB PROCEDURE

* 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

rotary neem

rotary sodoium hypochlorite IIC PROCEDURE

* 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

rotary sodium hypochloride

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University

Al Mansurah, 35516, Egypt

Location

Related Publications (3)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Dental Pulp Necrosis

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• mansoura university

  Mansoura University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Model Details: 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

Study Record Dates

• First Submitted: May 13, 2024
• First Posted: May 17, 2024
• Study Start: September 12, 2022
• Primary Completion: December 15, 2023
• Study Completion: May 12, 2024
• Last Updated: May 29, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)