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

NCT03763110 | Unknown

• 1 other identifier: Regenerative endodontic
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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. 1.Clinical success in terms of absence of any complication such as spontaneous pain, sinus or swelling.
2. 2.Radiographic success in terms of healing of periapical radiolucency or increase root thickness, length or apical closure.

Conditions

Pulp Necrosis

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (6)

• healing of sinus

  immediate post operative, 3 months, 6 months, 9 months, 12 months

• healing of swelling

  immediate post operative, 3 months, 6 months, 9 months, 12 months

• healing of periapical radiolucency

  baseline, 6 months, 12 months

• change in root length

  baseline, 6 months, 12 months

• change in dentin root thickness

  baseline, 6 months, 12 months

Study Arms (2)

Photo Activated Disinfection

EXPERIMENTAL

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

Antibiotic paste

ACTIVE COMPARATOR

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

Interventions

Photo Activated Disinfection DEVICE

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

Also known as: Photodynamic therapy (PDT)

Photo Activated Disinfection

antibiotic paste DRUG

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

Also known as: Triple antibiotic paste

Antibiotic paste

Eligibility Criteria

• Age: 8 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Root fracture.
• Internal or external root resorption.
• Parents or guardians refuse to participate in the study.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Dental Pulp Necrosis

Interventions

Photochemotherapy

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Phototherapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer in paediatric dentistry department at Fayoum university

Study Record Dates

• First Submitted: November 17, 2018
• First Posted: December 4, 2018
• Study Start: October 15, 2016
• Primary Completion: December 15, 2018
• Study Completion: April 15, 2019
• Last Updated: December 5, 2018

Record last verified: 2018-08