Photo-Activated Disinfection Versus Triple-Antibiotic Paste for Management of Necrotic Young Permanent Anterior Teeth

NCT ID: NCT03763110

Last Updated: 2018-12-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-15
• Study Completion Date: 2019-04-15

Brief Summary

This study aims to compare regenerative endodontics for necrotic young permanent anterior teeth using oral photo-activated disinfection versus triple antibiotic paste in terms of:

1. Clinical success in terms of absence of any complication such as spontaneous pain, sinus or swelling.

2. Radiographic success in terms of healing of periapical radiolucency or increase root thickness, length or apical closure.

Detailed Description

Disinfection of the root canal system is thought to be critical to the success of Regenerative Endodontic Procedures (REPs) as infection prevents regeneration, repair and stem cell activity . A suitable material for using as intra-canal medicament seems to be antibiotic. Triple antibiotic paste (TAP) containing metronidazole, ciprofloxacin and minocycline has been reported to be a successful regimen in controlling the root canal pathogen and in managing necrotic young permanent tooth .

Recently, new disinfection methods have been developed to overcome the limitations of conventional disinfecting protocols that they may neither reduce the number of bacteria to a satisfactory level nor minimize the toxicity to periapical stem/progenitors . Other concerns regarding the use of TAP are tooth discoloration after treatment and bacterial resistance. Photo-activated oral disinfection is a novel disinfection method which present a great solution for the problem associated with triple antibiotic paste

Conditions

Pulp Necrosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Photo Activated Disinfection

Photoactivated disinfection (PAD) is based on the interaction of a photosensitive antibacterial agent and a light source. It uses a nontoxic dye \[named photosensitizer PS\] and low-intensity visible light. In oxygen presentation, these combine to produce some cytotoxic species. The PS molecules attach to bacteria membrane

Group Type: EXPERIMENTAL

Photo Activated Disinfection

Intervention Type: DEVICE

Photoactivated disinfection (PAD) is based on the interaction of a photosensitive antibacterial agent and a light source. It uses a nontoxic dye \[named photosensitizer PS\] and low-intensity visible light. In oxygen presentation, these combine to produce some cytotoxic species. The PS molecules attach to bacteria membrane

Antibiotic paste

Hoshino et al. recommended a ratio of 1:1:1 of metronidazole (500 mg), minocycline (100 mg) and ciprofloxacin (200 mg) for the 3Mix formulation

Group Type: ACTIVE_COMPARATOR

antibiotic paste

Intervention Type: DRUG

An antibiotic mixture composed of ciprofloxacin, metronidazole, and minocycline, known as triple antibiotic paste (TAP) or "3mix", has been the most widely used medicament, This goes back to the studies by Hoshino et al.1996

Interventions

Photo Activated Disinfection

Photoactivated disinfection (PAD) is based on the interaction of a photosensitive antibacterial agent and a light source. It uses a nontoxic dye \[named photosensitizer PS\] and low-intensity visible light. In oxygen presentation, these combine to produce some cytotoxic species. The PS molecules attach to bacteria membrane

Intervention Type: DEVICE

antibiotic paste

An antibiotic mixture composed of ciprofloxacin, metronidazole, and minocycline, known as triple antibiotic paste (TAP) or "3mix", has been the most widely used medicament, This goes back to the studies by Hoshino et al.1996

Intervention Type: DRUG

Other Intervention Names

Photodynamic therapy (PDT); Triple antibiotic paste

Eligibility Criteria

Inclusion Criteria

• Healthy children with no physical, mental or systemic conditions.
• Developmental age of the child is the most important factor so periapical x- ray will be taken first to assure apex immaturity.
• No sex predilection.
• Restorable necrotic young permanent anterior teeth

Exclusion Criteria

• Root fracture.
• Internal or external root resorption.
• Parents or guardians refuse to participate in the study.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

ElShaimaa Abdelhafiz Abdelrahim

assistant lecturer in paediatric dentistry department at Fayoum university

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

Regenerative endodontic

Identifier Type: -

Identifier Source: org_study_id