Periapical PeriodontitisNCT01799187
Research of Revascularization in Immature Teeth With Periapical Periodontitis
A study testing revascularization and apexification in people with Periapical Periodontitis, run by Junqi Ling at 1 site in China.
Trial summary
Revascularization is an alternative new treatment of immature permanent teeth with necrotic pulp nowadays while apexification is the traditional therapy. The investigators suppose that revascularization is superior to apexification at developing the root of immature permanent teeth and reducing the risk of root… Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Periapical Periodontitis
- What is being tested?
- revascularization and apexification
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 1 siteChina
- Study dates
- Jul 2012to Jul 2021
- 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 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- clinical diagnosis of periapical periodontitis
- must be immature permanent teeth
- must be local Guangzhou
Who cannot join
- blood disease
- residual root that is advised to extract
- serious periodontitis
- women in pregnancy
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guanghua hospital of stomotology,Sun Yat-sen University
Guangzhou, Guangdong, 510055
ling j q, PhD, 020-83863002, lingjq@mail.sysu.edu.cn
About this study
Official title: Randomized Controlled Research of Revascularization in Immature Permanent Teeth With Periapical Periodontitis
Revascularization is an alternative new treatment of immature permanent teeth with necrotic pulp nowadays while apexification is the traditional therapy. The investigators suppose that revascularization is superior to apexification at developing the root of immature permanent teeth and reducing the risk of root fracture,and the research is designed.
Read the detailed description
The investigators design to collect a group of patients presenting immature permanent teeth with periapical periodontitis in certain criterion. The investigators will divide the patients into two groups randomly. One group will get treated with revascularization while the other with apexification. The investigators want to evaluate the short-term and long-term effects of the two groups to get a conclusion of the clinical value of revascularization.
- Conditions
- Periapical Periodontitis
- Being tested
- revascularization, apexification
- Keywords
- Immature Permanent Teeth
- Medical subject headings
- Periapical Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
revascularizationProcedure or surgery
revascularization include 3 steps: root disinfected,induction of bleeding and revascularization include 3 steps: root disinfected,induction of bleeding and sealing
apexificationProcedure or surgery
apexification uses calcium hydroxide as root medication
| Study group | Role | What they receive |
|---|---|---|
| revascularization | Experimental | revascularization is is an alternative new treatment of immature permanent teeth with necrotic pulp. The use of triple antibiotic paste is followed by Induction of bleeding from the apical root during this intervention. Receives: Procedure: revascularization |
| apexification | Active comparator | apexification is a traditional therapy of immature permanent teeth with necrotic pulp.calcium hydroxide is served as medication to induce the developing of root . Receives: Procedure: apexification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of lesion healing confirmed by cone beam computed tomography
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2013 (estimated)
- Study startJul 2012
- Primary completionJul 2015 (estimated)
- Study completionJul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Periapical PeriodontitisStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Junqi Ling
- Sponsor type
- University, hospital or other
- Collaborators
- Sun Yat-sen University
- Responsible party
- Sponsor-investigator, Junqi Ling, Sun Yat-sen University
- Investigators
- ling j qi, PhD, Study chair, Guanghua hospital of stomotology,Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01799187
- Sponsor's protocol ID
- 5010YT
- Other IDs
- jqling
- Status last verified
- Jul 2014
- First submitted
- 24 Feb 2013
- Last updated
- 22 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jung IY, Lee SJ, Hargreaves KM. Biologically based treatment of immature permanent teeth with pulpal necrosis: a case series. J Endod. 2008 Jul;34(7):876-87. doi: 10.1016/j.joen.2008.03.023. Epub 2008 May 16.
PubMed 18571000
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Research of Revascularization in Immature Permanent Teeth With Periapical Periodontitis
- ClinicalTrials.gov ID
- NCT01799187
- Acronym / sponsor ID
- 5010YT
- Conditions
- Periapical Periodontitis
- Keywords
- Immature Permanent Teeth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Junqi LingUniversity, hospital or other
- Collaborators
- Sun Yat-sen University
- Study start
- Jul 2012
- Primary completion
- Jul 2015 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 26 Feb 2013 (estimated)
- 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.
Revascularization is an alternative new treatment of immature permanent teeth with necrotic pulp nowadays while apexification is the traditional therapy. The investigators suppose that revascularization is superior to apexification at developing the root of immature permanent teeth and reducing the risk of root fracture,and the research is designed.
Detailed description
The investigators design to collect a group of patients presenting immature permanent teeth with periapical periodontitis in certain criterion. The investigators will divide the patients into two groups randomly. One group will get treated with revascularization while the other with apexification. The investigators want to evaluate the short-term and long-term effects of the two groups to get a conclusion of the clinical value of revascularization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| revascularization | Experimental | Procedure: revascularizationrevascularization is is an alternative new treatment of immature permanent teeth with necrotic pulp. The use of triple antibiotic paste is followed by Induction of bleeding from the apical root during this intervention. |
| apexification | Active comparator | Procedure: apexificationapexification is a traditional therapy of immature permanent teeth with necrotic pulp.calcium hydroxide is served as medication to induce the developing of root . |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- clinical diagnosis of periapical periodontitis
- must be immature permanent teeth
- must be local Guangzhou
Key exclusion criteria (4 listed)
- blood disease
- residual root that is advised to extract
- serious periodontitis
- women in pregnancy
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 |
|---|---|---|
| revascularizationrevascularization include 3 steps: root disinfected,induction of bleeding and revascularization include 3 steps: root disinfected,induction of bleeding and sealing | Procedure or surgery | revascularization |
| apexificationapexification uses calcium hydroxide as root medication | Procedure or surgery | apexification |
Primary outcome
Evidence of lesion healing confirmed by cone beam computed tomography
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2014.
- Background: PubMed 18571000Jung IY, Lee SJ, Hargreaves KM. Biologically based treatment of immature permanent teeth with pulpal necrosis: a case series. J Endod. 2008 Jul;34(7):876-87. doi: 10.1016/j.joen.2008.03.023. Epub 2008 May 16.
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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.
ling j qi, PhD study chair
Guanghua hospital of stomotology,Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing revascularization and apexification in people with Periapical Periodontitis, run by Junqi Ling at 1 site in China.
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 3 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: status not confirmed, as of the sponsor's last update on 22 Jul 2014. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ling J Qi, PhD (020-83863002, lingjq@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evidence of lesion healing confirmed by cone beam computed tomography (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01799187, which also lists 1 linked publication.
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 22 Jul 2014.