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

Study Overview
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Brief Summary
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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: Clinical success in terms of absence of any complication such as spontaneous pain, sinus or swelling. Radiographic success in terms of healing of periapical radiolucency or increase root thickness, length or apical closure.

Detailed Description
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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

Official Title
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Evaluation of Post-Operative Pain After Regenerative Endodontic Using Photo-Activated Oral Disinfection Versus Triple-Antibiotic Paste for Management of Necrotic Young Permanent Anterior Teeth

Conditions
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Pulp Necrosis

Intervention / Treatment
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* Device: Photo Activated Disinfection
* Drug: antibiotic paste


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Photo Activated Disinfection<br>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 | Device: Photo Activated Disinfection<br>* 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<br>* Other names: Photodynamic therapy (PDT);|
| Active Comparator: Antibiotic paste<br>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 | Drug: antibiotic paste<br>* 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<br>* Other names: Triple antibiotic paste;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| absence of postoperative pain | binary question by asking patients (yes or no) | immediate post operative | 
| absence of postoperative pain | binary question by asking patients (yes or no) | at 3 months follow up | 
| absence of postoperative pain | binary question by asking patients (yes or no) | at 6 months follow up | 
| absence of postoperative pain | binary question by asking patients (yes or no) | at 9 months follow up | 
| absence of postoperative pain | binary question by asking patients (yes or no) | at 12 months follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| healing of sinus | Clinical success in term of absence of sinus (Yes or No) | immediate post operative, 3 months, 6 months, 9 months, 12 months | 
| healing of swelling | Clinical success in term of absence of swelling (Yes or No) | immediate post operative, 3 months, 6 months, 9 months, 12 months | 
| healing of periapical radiolucency | Radiographic success in term of healing of periapical or radiolucency (Yes or No) | baseline, 6 months, 12 months | 
| change in root length | Radiographic evaluation by calibration of root length in millimetre by Digora | baseline, 6 months, 12 months | 
| change in dentin root thickness | Radiographic evaluation by calibration of root thickness in millimetre by Digora | baseline, 6 months, 12 months | 
| change in apical diameter | Radiographic evaluation by calibration of apical diameter in millimetre by Digora | baseline, 6 months, 12 months |