Pulp NecrosisNCT03763110
Photo-Activated Disinfection Versus Triple-Antibiotic Paste for Management of Necrotic Young Permanent Anterior Teeth
A study testing Photo Activated Disinfection and antibiotic paste in people with Pulp Necrosis, run by Cairo University.
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. Read more about this study
- Who is it for?
- Ages 8 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulp Necrosis
- What is being tested?
- Photo Activated Disinfection and antibiotic paste
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2016to 15 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- Root fracture.
- Internal or external root resorption.
- Parents or guardians refuse to participate in the study.
About this study
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
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.
Read the 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
- Conditions
- Pulp Necrosis
- Being tested
- Photo Activated Disinfection, antibiotic paste
- Medical subject headings
- Dental Pulp Necrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photo Activated DisinfectionDevice
Also called Photodynamic therapy (PDT)
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
antibiotic pasteDrug
Also called Triple 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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: antibiotic paste |
What is being measured
The primary outcome is the main question the study is designed to answer.
absence of postoperative pain
binary question by asking patients (yes or no)
Measured: immediate post operative
absence of postoperative pain
binary question by asking patients (yes or no)
Measured: at 3 months follow up
absence of postoperative pain
binary question by asking patients (yes or no)
Measured: at 6 months follow up
absence of postoperative pain
binary question by asking patients (yes or no)
Measured: at 9 months follow up
absence of postoperative pain
binary question by asking patients (yes or no)
Measured: at 12 months follow up
Secondary outcomes (6)
healing of sinus
Clinical success in term of absence of sinus (Yes or No)
Measured: 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)
Measured: 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)
Measured: baseline, 6 months, 12 months
change in root length
Radiographic evaluation by calibration of root length in millimetre by Digora
Measured: baseline, 6 months, 12 months
change in dentin root thickness
Radiographic evaluation by calibration of root thickness in millimetre by Digora
Measured: baseline, 6 months, 12 months
change in apical diameter
Radiographic evaluation by calibration of apical diameter in millimetre by Digora
Measured: baseline, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2018
- Study start15 Oct 2016
- Primary completion15 Dec 2018 (estimated)
- Study completion15 Apr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulp NecrosisStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ElShaimaa Abdelhafiz Abdelrahim, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03763110
- Sponsor's protocol ID
- Regenerative endodontic
- Status last verified
- Aug 2018
- First submitted
- 17 Nov 2018
- Last updated
- 5 Dec 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03763110
- Acronym / sponsor ID
- Regenerative endodontic
- Conditions
- Pulp Necrosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Oct 2016 (actual)
- Primary completion
- 15 Dec 2018 (estimated)
- Study completion
- 15 Apr 2019 (estimated)
- First posted
- 4 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Photo Activated Disinfection | Experimental | Device: Photo Activated DisinfectionPhotoactivated 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 |
| Antibiotic paste | Active comparator | Drug: antibiotic pasteHoshino et al. recommended a ratio of 1:1:1 of metronidazole (500 mg), minocycline (100 mg) and ciprofloxacin (200 mg) for the 3Mix formulation |
Who may qualify
- Ages
- 8 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Root fracture.
- Internal or external root resorption.
- Parents or guardians refuse to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Photo Activated DisinfectionAlso: Photodynamic therapy (PDT)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 pasteAlso: Triple antibiotic pasteAn 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 | Drug | Antibiotic paste |
Primary outcome
absence of postoperative pain
Time frame: immediate post operative
binary question by asking patients (yes or no)
absence of postoperative pain
Time frame: at 3 months follow up
binary question by asking patients (yes or no)
absence of postoperative pain
Time frame: at 6 months follow up
binary question by asking patients (yes or no)
absence of postoperative pain
Time frame: at 9 months follow up
binary question by asking patients (yes or no)
absence of postoperative pain
Time frame: at 12 months follow up
binary question by asking patients (yes or no)
6 secondary outcomes
healing of sinus
Time frame: immediate post operative, 3 months, 6 months, 9 months, 12 months
healing of swelling
Time frame: immediate post operative, 3 months, 6 months, 9 months, 12 months
healing of periapical radiolucency
Time frame: baseline, 6 months, 12 months
change in root length
Time frame: baseline, 6 months, 12 months
change in dentin root thickness
Time frame: baseline, 6 months, 12 months
change in apical diameter
Time frame: baseline, 6 months, 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Photo Activated Disinfection and antibiotic paste in people with Pulp Necrosis, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
absence of postoperative pain (time frame: immediate post operative). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2018.