RevascularizationNCT03507556
Regeneration of Immature Teeth. Case Series
A study testing Triple paste and induced bleeding and Triple Paste metronidazole, ciprofloxacin and minocycline mixed with sterile glycol in people with Revascularization, run by Jordan University of Science and Technology at 1 site in Jordan.
Trial summary
This clinical study aims to investigate the predictability of revascularization procedure of immature necrotic human permanent teeth with apical periodontitis. The quality of root development (thickness and length) will be assessed radiographically. Read more about this study
- Who is it for?
- Ages 6 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Revascularization
- What is being tested?
- Triple paste and induced bleeding and Triple Paste metronidazole, ciprofloxacin and minocycline mixed with sterile glycol
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteJordan
- Study dates
- 28 Jun 2010to 1 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 6 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Teeth diagnosed with necrotic pulp with/without evidence of apical periodontitis.
- An immature/open apex.
- Tooth does not need post and core restoration.
- Medically healthy patients with no known allergy to used materials.
Who cannot join
- Medically compromised patient,
- Teeth with periodontal involvement
- Teeth with vertical root fractures,
- Non-restorable teeth,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Regenerative Potential of Immature Necrotic Teeth With Apical Periodontitis Based on Clinical and Radiographic Assessments
This clinical study aims to investigate the predictability of revascularization procedure of immature necrotic human permanent teeth with apical periodontitis. The quality of root development (thickness and length) will be assessed radiographically.
Read the detailed description
All teeth will be disinfected using either triple antibiotic paste (a mixture of metronidazole, ciprofloxacin and amoxicillin mixed with sterile glycole) or non setting calcium hydroxide applied to the pulp space with a sterile lentulospiral and then closed temporarily with a sterile sponge and temporary restoration for 2-3 weeks to allow disinfection of the canals teeth will be reentered under rubber dam isolation and all intracanal medicaments will be washed out from the canal using 10 ml of 2.5% sodium hypochlorite and 20 ml of Ethylene diamine tetra acetic acid (EDTA). Then, a sterile endodontic file will be inserted past the canal terminus into the periapical tissues to induce bleeding to fill the canal space as much as possible and subsequently sealed with a double coronal seal using bioceramic repair material and composite filling. All the teeth will be monitored clinically and radiographically on a biannual basis.
- Conditions
- Revascularization
- Being tested
- Triple paste and induced bleeding, Triple Paste metronidazole, ciprofloxacin and minocycline mixed with sterile glycol
- Keywords
- immature teeth, necrotic teeth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triple paste and induced bleedingProcedure or surgery
Triple Paste metronidazole, ciprofloxacin and minocycline mixed with sterile glycolDrug
triple paste of metronidazole, ciprofloxacin and minocycline mixed with sterile glycol
| Study group | Role | What they receive |
|---|---|---|
| Triple paste and induced bleeding | Experimental | The triple paste is a mixture of metronidazole, ciprofloxacin and minocycline mixed with sterile glycol will be used and next visit intracanal bleeding will be induced Receives: Procedure: Triple paste and induced bleeding; Drug: Triple Paste metronidazole, ciprofloxacin and minocycline mixed with sterile glycol |
What is being measured
The primary outcome is the main question the study is designed to answer.
complete healing
Assess clinically and radiographically absence of symptoms and signs. And evidence for continuation of root development
Measured: from start of intervention up to 100 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2018
- Study start28 Jun 2010
- Primary completionNov 2021 (estimated)
- Study completion1 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RevascularizationStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Revascularization for immature necrotic permanent teeth with apical periodontitis.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jordan University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03507556
- Sponsor's protocol ID
- JordanUST1
- Status last verified
- Feb 2020
- First submitted
- 15 Apr 2018
- Last updated
- 25 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Regenerative Potential of Immature Necrotic Teeth With Apical Periodontitis Based on Clinical and Radiographic Assessments
- ClinicalTrials.gov ID
- NCT03507556
- Acronym / sponsor ID
- JordanUST1
- Conditions
- Revascularization
- Keywords
- immature teeth, necrotic teeth
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Jordan University of Science and TechnologyUniversity, hospital or other
- Study start
- 28 Jun 2010 (actual)
- Primary completion
- Nov 2021 (estimated)
- Study completion
- 1 Dec 2030 (estimated)
- First posted
- 25 Apr 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 clinical study aims to investigate the predictability of revascularization procedure of immature necrotic human permanent teeth with apical periodontitis. The quality of root development (thickness and length) will be assessed radiographically.
Detailed description
All teeth will be disinfected using either triple antibiotic paste (a mixture of metronidazole, ciprofloxacin and amoxicillin mixed with sterile glycole) or non setting calcium hydroxide applied to the pulp space with a sterile lentulospiral and then closed temporarily with a sterile sponge and temporary restoration for 2-3 weeks to allow disinfection of the canals teeth will be reentered under rubber dam isolation and all intracanal medicaments will be washed out from the canal using 10 ml of 2.5% sodium hypochlorite and 20 ml of Ethylene diamine tetra acetic acid (EDTA). Then, a sterile endodontic file will be inserted past the canal terminus into the periapical tissues to induce bleeding to fill the canal space as much as possible and subsequently sealed with a double coronal seal using bioceramic repair material and composite filling. All the teeth will be monitored clinically and radiographically on a biannual basis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Revascularization for immature necrotic permanent teeth with apical periodontitis.
| Arm | Type | Receives |
|---|---|---|
| Triple paste and induced bleeding | Experimental | Procedure: Triple paste and induced bleeding, Drug: Triple Paste metronidazole, ciprofloxacin and minocycline mixed with sterile glycolThe triple paste is a mixture of metronidazole, ciprofloxacin and minocycline mixed with sterile glycol will be used and next visit intracanal bleeding will be induced |
Who may qualify
- Ages
- 6 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Teeth diagnosed with necrotic pulp with/without evidence of apical periodontitis.
- An immature/open apex.
- Tooth does not need post and core restoration.
- Medically healthy patients with no known allergy to used materials.
Key exclusion criteria (4 listed)
- Medically compromised patient,
- Teeth with periodontal involvement
- Teeth with vertical root fractures,
- Non-restorable teeth,
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 |
|---|---|---|
| Triple paste and induced bleeding | Procedure or surgery | Triple paste and induced bleeding |
| Triple Paste metronidazole, ciprofloxacin and minocycline mixed with sterile glycoltriple paste of metronidazole, ciprofloxacin and minocycline mixed with sterile glycol | Drug | Triple paste and induced bleeding |
Primary outcome
complete healing
Time frame: from start of intervention up to 100 months.
Assess clinically and radiographically absence of symptoms and signs. And evidence for continuation of root development
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2020.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Triple paste and induced bleeding and Triple Paste metronidazole, ciprofloxacin and minocycline mixed with sterile glycol in people with Revascularization, run by Jordan University of Science and Technology at 1 site in Jordan.
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 4 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: under way, not looking for participants, as of the sponsor's last update on 25 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
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?
complete healing (time frame: from start of intervention up to 100 months.). 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 25 Feb 2020.