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Completed

NCT Number: NCT06418386

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

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.

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Key information

Conditions

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

Age range

4 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mansoura University

Al Mansurah, 35516, Egypt

About this study

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 :

  • Psychological management of child
  • X-ray for inclusion criteria
  • 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 sterilized round bur and root canal access will be done
  • On gaining the access, 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).
  • 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.
  • In group II will be prepared with rotary files the irrigation with saline in IIA, with neem in IIB, with NaOCl in IIC
  • 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.
  • 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

Laboratory procedures :

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 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 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

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 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 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

Primary outcomes

  1. number of of colony forming units

    Time frame: 48 hours after culture

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

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
May 17, 2024
Registry last updated
May 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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