Photo-Activated Disinfection Versus Triple-Antibiotic Paste for Management of Necrotic Young Permanent Anterior Teeth
Primary Purpose
Pulp Necrosis
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Photo Activated Disinfection
antibiotic paste
Sponsored by
About this trial
This is an interventional treatment trial for Pulp Necrosis
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Photo Activated Disinfection
Antibiotic paste
Arm Description
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
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
Outcomes
Primary Outcome Measures
absence of postoperative pain
binary question by asking patients (yes or no)
absence of postoperative pain
binary question by asking patients (yes or no)
absence of postoperative pain
binary question by asking patients (yes or no)
absence of postoperative pain
binary question by asking patients (yes or no)
absence of postoperative pain
binary question by asking patients (yes or no)
Secondary Outcome Measures
healing of sinus
Clinical success in term of absence of sinus (Yes or No)
healing of swelling
Clinical success in term of absence of swelling (Yes or No)
healing of periapical radiolucency
Radiographic success in term of healing of periapical or radiolucency (Yes or No)
change in root length
Radiographic evaluation by calibration of root length in millimetre by Digora
change in dentin root thickness
Radiographic evaluation by calibration of root thickness in millimetre by Digora
change in apical diameter
Radiographic evaluation by calibration of apical diameter in millimetre by Digora
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03763110
Brief Title
Photo-Activated Disinfection Versus Triple-Antibiotic Paste for Management of Necrotic Young Permanent Anterior Teeth
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 15, 2016 (Actual)
Primary Completion Date
December 15, 2018 (Anticipated)
Study Completion Date
April 15, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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:
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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulp Necrosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Photo Activated Disinfection
Arm Type
Experimental
Arm Description
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
Arm Title
Antibiotic paste
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Photo Activated Disinfection
Other Intervention Name(s)
Photodynamic therapy (PDT)
Intervention Description
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
Drug
Intervention Name(s)
antibiotic paste
Other Intervention Name(s)
Triple antibiotic paste
Intervention Description
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
Primary Outcome Measure Information:
Title
absence of postoperative pain
Description
binary question by asking patients (yes or no)
Time Frame
immediate post operative
Title
absence of postoperative pain
Description
binary question by asking patients (yes or no)
Time Frame
at 3 months follow up
Title
absence of postoperative pain
Description
binary question by asking patients (yes or no)
Time Frame
at 6 months follow up
Title
absence of postoperative pain
Description
binary question by asking patients (yes or no)
Time Frame
at 9 months follow up
Title
absence of postoperative pain
Description
binary question by asking patients (yes or no)
Time Frame
at 12 months follow up
Secondary Outcome Measure Information:
Title
healing of sinus
Description
Clinical success in term of absence of sinus (Yes or No)
Time Frame
immediate post operative, 3 months, 6 months, 9 months, 12 months
Title
healing of swelling
Description
Clinical success in term of absence of swelling (Yes or No)
Time Frame
immediate post operative, 3 months, 6 months, 9 months, 12 months
Title
healing of periapical radiolucency
Description
Radiographic success in term of healing of periapical or radiolucency (Yes or No)
Time Frame
baseline, 6 months, 12 months
Title
change in root length
Description
Radiographic evaluation by calibration of root length in millimetre by Digora
Time Frame
baseline, 6 months, 12 months
Title
change in dentin root thickness
Description
Radiographic evaluation by calibration of root thickness in millimetre by Digora
Time Frame
baseline, 6 months, 12 months
Title
change in apical diameter
Description
Radiographic evaluation by calibration of apical diameter in millimetre by Digora
Time Frame
baseline, 6 months, 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
12. IPD Sharing Statement
Learn more about this trial
Photo-Activated Disinfection Versus Triple-Antibiotic Paste for Management of Necrotic Young Permanent Anterior Teeth
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