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

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

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.

Study Overview

• Status: Unknown
• Conditions: Pulp Necrosis
• Intervention / Treatment: Device: Photo Activated Disinfection; Drug: antibiotic paste

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

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 9 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Device: 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; Other Names: Photodynamic therapy (PDT)
Active Comparator: 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	Drug: 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; Other Names: Triple antibiotic paste

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2016
• Primary Completion (Anticipated): December 15, 2018
• Study Completion (Anticipated): April 15, 2019

Study Registration Dates

• First Submitted: November 17, 2018
• First Submitted That Met QC Criteria: December 1, 2018
• First Posted (Actual): December 4, 2018

Study Record Updates

• Last Update Posted (Actual): December 5, 2018
• Last Update Submitted That Met QC Criteria: December 4, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Stomatognathic Diseases; Tooth Diseases; Dental Pulp Diseases; Necrosis; Dental Pulp Necrosis; Anti-Infective Agents; Antitubercular Agents; Anti-Bacterial Agents; Antibiotics, Antitubercular
• Other Study ID Numbers: Regenerative Endodontic

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No