Pulp Necrosis
Conditions
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
Interventions
DEVICEPhoto 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
DRUGantibiotic 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
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
8 Years to 13 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| absence of postoperative pain | immediate post operative | binary question by asking patients (yes or no) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| healing of periapical radiolucency | baseline, 6 months, 12 months | Radiographic success in term of healing of periapical or radiolucency (Yes or No) |
| 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) |
| 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 |
| change in root length | baseline, 6 months, 12 months | Radiographic evaluation by calibration of root length in millimetre by Digora |
Outcome results
None listed