Efficiency of Triple Antibiotic Paste, Ciprofloxacin/Propolis, Ciprofloxacin/Metronidazole, Propolis/Metronidazole Combinations on Revascularization Process of Immature Necrotic Maxillary Incisors of Patients 8-18 Years Old.

NCT03533231 | Completed Phase 4

• 1 other identifier: FDASU-RECID011508
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

This Study Was Made to Evaluate the Antibacterial Effect of Different Antibacterial Combinations on Revascularization Process in Permanent Anterior Immature Teeth. Immature Necrotic Permanent Maxillary Incisors (n = 40) of Patients 8-18 Years Old Were Divided Into 4 Equal Groups (Each n = 10) According to the Intracanal Medicament: Group 1 Was Treated With Triple Antibiotic Paste (TAP), Group 2 Was Treated With Ciprofloxacin + Propolis Paste (CP), Group 3 Was Treated With Ciprofloxacin + Metronidazole Paste (CM), Group 4 Was Treated With Propolis + Metronidazole Paste (PM). Cases Were Followed at Regular Intervals up to 18 Months Clinically and Radiographically.

Conditions

Dental Pulp Necrosis; Periapical Abscess; Root Canal Infection

Keywords

Pulp regeneration, intracanal medication

Outcome Measures

Primary Outcomes (4)

• Change in periapical pathosis

  Change in periapical bone density on follow up radiographs

  baseline, 3 months, 6 months, 9 months, 12 months, and 18 months

• Change in root length

  Change in root length on follow up radiographs

  baseline, 3 months, 6 months, 9 months, 12 months, and 18 months

• Change in root thickness

  Change in root thickness on follow up radiographs

  baseline, 3 months, 6 months, 9 months, 12 months, and 18 months

• Change in apical diameter

  Change in apical diameter on follow up radiographs

  baseline, 3 months, 6 months, 9 months, 12 months, and 18 months

Study Arms (4)

Triple Antibiotic Paste (TAP)

ACTIVE COMPARATOR

It consisted of Ciprofloxacin (Ciprocin 250 mg tablets; EPICO, Cairo, Egypt), Metronidazole (Flagyl 500 mg tablets; Sanofi Aventis Pharma, Cairo, Egypt), Doxycycline (Vibramycin 100 mg capsules; Pfizer, Cairo, Egypt). One Doxycycline capsule content was evacuated in a sterile mortar, one tablet of metronidazole and one tablet of ciprofloxacin were crushed and ground in the same mortar using a pestle into homogenous powder. Saline drops (Otrivin baby saline; Novartis, Cairo, Egypt) were added and mixed using the pestle until a creamy paste was achieved (Sabrah et al. 2013, Nagy et al. 2014). TAP was then used for canal disinfection.

Combination Product: Canal Disinfection Triple Antibiotic Paste (TAP)

Ciprofloxacin + Propolis Paste

EXPERIMENTAL

Ethanol extract of raw propolis (EEP; ElEzaby Co. Labs, Cairo, Egypt.) was prepared by adding 10 gm of propolis (Imtinan, Cairo, Egypt) to 40 gm of 70% ethanol (ElGomhorya Co., Cairo, Egypt) (for 20% tincture) in a dark container to prevent reduction of propolis. The container was sealed and placed at room temperature for a period of three weeks. The sealed container was manually shaken every 2 days to ensure proper mixing. After 3 weeks, the container was opened and ethanol extract of propolis was obtained. Ethanol-free EEP was made by evaporating the ethanol in a water bath. EEP was then mixed with Ciprofloxacin powder in the ratio 1:1. Saline drops were added and mixed using the pestle until a creamy paste was achieved. This paste was then used for canal disinfection.

Combination Product: Ciprofloxacin + Propolis Paste

Ciprofloxacin + Metronidazole Paste

ACTIVE COMPARATOR

Ciprofloxacin powder was mixed with Metronidazole powder in the ratio 1:1. Saline drops were added and mixed using the pestle until a creamy paste was achieved. This paste was then used for canal disinfection.

Combination Product: Ciprofloxacin + Metronidazole Paste

Propolis + Metronidazole paste

EXPERIMENTAL

Ethanol Extract of Propolis (EEP) was mixed with Metronidazole powder in the ratio 1:1. Saline drops were added and mixed using the pestle until a creamy paste was achieved. This paste was then used for canal disinfection.

Combination Product: Propolis + Metronidazole paste

Interventions

Canal Disinfection Triple Antibiotic Paste (TAP) COMBINATION_PRODUCT

Patients were treated as follows: Caries was excavated; access cavity was prepared. The rubber dam was then applied and working length was determined. Canal space was irrigated using 40 cc of NaOCl 2.6% solution and final flush of saline. Canal space was dried using paper points. One cc of the prepared paste was injected into the canals using a sterile plastic syringe with 20" gauge needle. The access cavity was then sealed using temporary restoration. After the 3 weeks, anesthesia without vasoconstrictor was administrated. The antibiotic paste was removed and the canal was irrigated using a sterile saline and dried using paper points. Sterile hand file size #25 was introduced into the root canal beyond the working length to induce bleeding. The bleeding was allowed to reach a 3-mm level below the cemento-enamel junction. MTA was used to seal the root canal at the cervical level. After one week, adhesive composite resin was used to seal the access cavity.

Triple Antibiotic Paste (TAP)

Ciprofloxacin + Propolis Paste COMBINATION_PRODUCT

Ciprofloxacin + Propolis Paste

Ciprofloxacin + Metronidazole Paste COMBINATION_PRODUCT

Ciprofloxacin + Metronidazole Paste

Propolis + Metronidazole paste COMBINATION_PRODUCT

Propolis + Metronidazole paste

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Permanent anterior teeth having immature apex.
• Established radiographic periapical pathosis.
• History of previous trauma.
• Compliant patient/parent.

You may not qualify if:

• teeth with vertical fractures, periodontally involved teeth, and nonrestorable teeth.
• Patients with vital teeth.
• Patients with heart disease or systemic disorders.

Sponsors & Collaborators

• Tariq Yehia: lead

MeSH Terms

Conditions

Dental Pulp Necrosis; Periapical Abscess

Interventions

Ciprofloxacin; Propolis

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Abscess; Suppuration; Infections; Periapical Periodontitis; Periapical Diseases; Jaw Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Resins, Plant; Biopolymers; Polymers; Macromolecular Substances; Plant Exudates; Biological Products; Complex Mixtures

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer of Endodontics

Study Record Dates

• First Submitted: April 24, 2018
• First Posted: May 23, 2018
• Study Start: January 16, 2015
• Primary Completion: October 1, 2017
• Study Completion: January 1, 2018
• Last Updated: May 30, 2018

Record last verified: 2018-05