Photo-Activated Disinfection Versus Triple-Antibiotic Paste for Management of Necrotic Young Permanent Anterior Teeth
- Conditions
- Pulp Necrosis
- Interventions
- Device: Photo Activated DisinfectionDrug: antibiotic paste
- Registration Number
- NCT03763110
- Lead Sponsor
- Cairo University
- 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 40
- 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
- Root fracture.
- Internal or external root resorption.
- Parents or guardians refuse to participate in the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Photo Activated Disinfection 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 Antibiotic paste 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
- Primary Outcome Measures
Name Time Method absence of postoperative pain at 12 months follow up binary question by asking patients (yes or no)
- Secondary Outcome Measures
Name Time Method healing of sinus immediate post operative, 3 months, 6 months, 9 months, 12 months Clinical success in term of absence of sinus (Yes or No)
healing of periapical radiolucency baseline, 6 months, 12 months Radiographic success in term of healing of periapical or radiolucency (Yes or No)
change in root length baseline, 6 months, 12 months Radiographic evaluation by calibration of root length in millimetre by Digora
change in dentin root thickness baseline, 6 months, 12 months Radiographic evaluation by calibration of root thickness in millimetre by Digora
change in apical diameter baseline, 6 months, 12 months Radiographic evaluation by calibration of apical diameter in millimetre by Digora
healing of swelling immediate post operative, 3 months, 6 months, 9 months, 12 months Clinical success in term of absence of swelling (Yes or No)