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

Pulp Necrosis Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03763110
• Other study ID #: Regenerative endodontic
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 15, 2016
• Est. completion date: April 15, 2019

Study information

• Verified date: August 2018
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: April 15, 2019
• Est. primary completion date: December 15, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 13 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Pulp Necrosis
• Necrosis
• Pulp Necrosis

Intervention

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

Drug:
• antibiotic paste
An antibiotic mixture composed of cipro?oxacin, 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	absence of postoperative pain	binary question by asking patients (yes or no)	immediate post operative
Primary	absence of postoperative pain	binary question by asking patients (yes or no)	at 3 months follow up
Primary	absence of postoperative pain	binary question by asking patients (yes or no)	at 6 months follow up
Primary	absence of postoperative pain	binary question by asking patients (yes or no)	at 9 months follow up
Primary	absence of postoperative pain	binary question by asking patients (yes or no)	at 12 months follow up
Secondary	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
Secondary	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
Secondary	healing of periapical radiolucency	Radiographic success in term of healing of periapical or radiolucency (Yes or No)	baseline, 6 months, 12 months
Secondary	change in root length	Radiographic evaluation by calibration of root length in millimetre by Digora	baseline, 6 months, 12 months
Secondary	change in dentin root thickness	Radiographic evaluation by calibration of root thickness in millimetre by Digora	baseline, 6 months, 12 months
Secondary	change in apical diameter	Radiographic evaluation by calibration of apical diameter in millimetre by Digora	baseline, 6 months, 12 months