Clinical and Radiographic Evaluation of the Synergistic Effect of Nano Silver Particles and Calcium Hydroxide Versus Triple Antibiotic Paste as Antibacterial Agents for Lesion Sterilization and Tissue Repair (LSTR) in Necrotic Primary Molars

NCT05681221 | Unknown

• 1 other identifier: LSTR
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

Brief Summary

Could the clinical and radiographic success of Nano Silver Particles and Calcium Hydroxide be comparable to that of Triple Antibiotic Paste as antibacterial agents for Lesion Sterilization and Tissue Repair (LSTR) in necrotic second primary molars?

Conditions

Root Canal Infection

Keywords

primary teeth; LSTR; necrotic

Outcome Measures

Primary Outcomes (4)

• Pathological mobility

  presence/ absence. Mobility test by applying pressure using the handle of dental mirrors

  1 year.

• Post-operative pain

  presence/ absence. Verbal question to patient/ parent.

  1 year.

• Soft tissue pathology

  presence/ absence. Visual clinical examination

  1 year.

• Pain to percussion

  presence/ absence. Percussion test by the handle of the dental mirror

  1 year.

Secondary Outcomes (2)

• Absence of furcation or periapical radiolucency

  1 year.

• Absence of external or internal root resorption

  1 year.

Study Arms (2)

LSTR in necrotic primary second molar using TAP

ACTIVE COMPARATOR

Triple antibiotic paste (TAP) is considered the gold standard in LSTR. It is a combination of ciprofloxacin, metronidazole and minocycline. Many anaerobic bacteria are resistant to ciprofloxacin. Hence, it is often used with metronidazole in treating mixed infections to compensate for its limited scope. Therefore, TAP can affect gram-negative, gram-positive, and anaerobic bacteria, and this combination can be effective against odontogenic microorganisms.

Other: TAP

LSTR in necrotic primary second molar using nano silver particles and calcium hydroxide

EXPERIMENTAL

Nano silver particles have a strong anti-bacterial properties due to its ability to target the bacteria on different cellular levels. Calcium hydroxide has been used for so long as an intra canal medication in odontogenic infections due to its strong alkalinity that gives it its anti bacterial properties. This combination might be a future alternative to antibiotics, in an attempt to decrease the bacterial antibiotic resistance and antibiotics use.

Other: Nano silver particles and calcium hydroxide

Interventions

Nano silver particles and calcium hydroxide OTHER

Combination of two materials that can possibly eradicate the mixed odontogenic infection in the periapical area and dentinal tubules in necrotic primary second molars.

LSTR in necrotic primary second molar using nano silver particles and calcium hydroxide

TAP OTHER

Triple antibiotic paste (TAP) is considered the gold standard in LSTR. It is a combination of ciprofloxacin, metronidazole and minocycline. Many anaerobic bacteria are resistant to ciprofloxacin. Hence, it is often used with metronidazole in treating mixed infections to compensate for its limited scope. Therefore, TAP can affect gram-negative, gram-positive, and anaerobic bacteria, and this combination can be effective against odontogenic microorganisms.

LSTR in necrotic primary second molar using TAP

Eligibility Criteria

• Age: 4 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children aged between 4 years and 7 years.
• Restorable necrotic mandibular second primary molars
• Mandibular lower second primary molar with signs of radiolucency in periapical or furcation area.
• Mandibular lower second primary molar with widening of PDL space or loss of lamina dura continuity.
• Mandibular lower second primary molar with evidence of internal/external pathologic root resorption.
• Signs of radiolucency in periapical or furcation area.
• Widening of PDL space or loss of lamina dura continuity.
• Evidence of internal/external pathologic root resorption.
• External root resorption from 1% to 50%.

You may not qualify if:

• Children that are not apparently healthy.
• Lack of informed consent by the child patient's parent.
• Patients allergic to any antibiotic used in the preparation of the TAP.
• Unable to attend follow-up visits.
• Refusal of participation.
• External root resorption above 50%.

Sponsors & Collaborators

• Cairo University: lead

Related Publications (8)

• Shetty A, Geethanjali G, Hegde A. Lesion sterilization and tissue repair in primary teeth. SRM Journal of Research in Dental Sciences. 2020;11(2):99. doi:10.4103/srmjrds.srmjrds_87_19

  BACKGROUND

• Takushige T, Cruz EV, Asgor Moral A, Hoshino E. Endodontic treatment of primary teeth using a combination of antibacterial drugs. Int Endod J. 2004 Feb;37(2):132-8. doi: 10.1111/j.0143-2885.2004.00771.x.

  PMID: 14871180 BACKGROUND

• Motiwala MA, Habib S, Ghafoor R, Irfan S. Comparison of antimicrobial efficacy of Calcipex and Metapex in endodontic treatment of chronic apical periodontitis: a randomised controlled trial study protocol. BMJ Open. 2021 Jul 21;11(7):e048947. doi: 10.1136/bmjopen-2021-048947.

  PMID: 34290069 BACKGROUND

• Mohammadi Z, Shalavi S, Yazdizadeh M. Antimicrobial activity of calcium hydroxide in endodontics: a review. Chonnam Med J. 2012 Dec;48(3):133-40. doi: 10.4068/cmj.2012.48.3.133. Epub 2012 Dec 21.

  PMID: 23323217 BACKGROUND

• Afkhami F, Pourhashemi SJ, Sadegh M, Salehi Y, Fard MJ. Antibiofilm efficacy of silver nanoparticles as a vehicle for calcium hydroxide medicament against Enterococcus faecalis. J Dent. 2015 Dec;43(12):1573-9. doi: 10.1016/j.jdent.2015.08.012. Epub 2015 Aug 29.

  PMID: 26327612 BACKGROUND

• Zapór L. Effects of silver nanoparticles of different sizes on cytotoxicity and oxygen metabolism disorders in both reproductive and respiratory system cells. Archives of Environmental Protection. 2016;42(4):32-47. doi:10.1515/aep-2016-0038

  BACKGROUND

• Riaz Z, Raza M, Hanif A, Haider B, Akram S, Safdar S. Antibacterial efficacy of silver nanoparticles impregnated calcium hydroxide: An in vitro study. J Pak Dent Assoc 2022;31(1):1-4

  BACKGROUND

• Deepak BM, Prabhakar AR, Karuna YM, Sugandhan S, Zahoor N, Mahendrapa Shagale A. Evaluation of the Antibacterial Activity of Triclosan-incorporated Root Canal Filling Materials for Primary Teeth against Enterococcus faecalis. Int J Clin Pediatr Dent. 2021 May-Jun;14(3):393-397. doi: 10.5005/jp-journals-10005-1960.

  PMID: 34720513 BACKGROUND

MeSH Terms

Conditions

Necrosis

Interventions

Calcium Hydroxide

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Calcium Compounds; Anions; Ions; Electrolytes

Study Officials

• Rania A. Nasr, PhD

  Cairo University

  STUDY CHAIR

Central Study Contacts

Sohair M. Aly, BSc

CONTACT

+201006202025; sohair_magdy@dentistry.cu.edu.eg

Reem M. Wahby, PhD

CONTACT

reemwahby@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Resident at Cairo University

Model Details: TAP is an efficient antibacterial for the disinfection of the periapical area in the necrotic primary second molars as well as the infected dentinal tubules. It is effective against the persistent odontogenic infections.

Study Record Dates

• First Submitted: December 13, 2022
• First Posted: January 12, 2023
• Study Start: February 20, 2023
• Primary Completion: March 1, 2024
• Study Completion: June 1, 2024
• Last Updated: January 12, 2023

Record last verified: 2022-12