Periapical DiseasesNCT02196740
Research of the Application of Triple Antibiotic Paste in Primary Teeth With Pericpical Periodontitis
A study testing Metronidazole-Ciprofloxacin gatifloxacin-Clindamycin paste and creosote in people with Periapical Diseases, run by Lin Jiacheng at 1 site in China.
Trial summary
The triple antibiotic paste is widely used in young permanent teeth and permanent teeth root canal therapy with excellent antiantimicrobial effect.We hypothesize that its application in the treatment of periapical periodontitis of deciduous teeth is superior to other drugs currently in use as creosote. Read more about this study
- Who is it for?
- Ages 3 to 8 years
- Conditions the study is for
- Periapical Diseases
- What is being tested?
- Metronidazole-Ciprofloxacin gatifloxacin-Clindamycin paste and creosote
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Jun 2013to Jun 2015
- 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 3 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- clinical diagnosis of periapical periodontitis
- must be primary teeth
- must be 3~8 years old
- the permanent tooth germ is complete and didnot be involved
Who cannot join
- blood disease
- residual root that is advised to extract
- serious periodontitis
- allergy to the triple antibiotic paste
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Research of the Application of Triple Antibiotic Paste in Primary Teeth With
The triple antibiotic paste is widely used in young permanent teeth and permanent teeth root canal therapy with excellent antiantimicrobial effect.We hypothesize that its application in the treatment of periapical periodontitis of deciduous teeth is superior to other drugs currently in use as creosote.
Read the detailed description
We design to collect a group of patients presenting primary teeth with periapical periodontitis in certain criterion. We will divide the patients into two groups randomly.One group will get treated with triple antibiotic paste while the other with creosote.We want to evaluate the short-term and long-term effects of the two groups to get a conclusion of the clinical value of triple antibiotic paste.
- Conditions
- Periapical Diseases
- Being tested
- Metronidazole-Ciprofloxacin gatifloxacin-Clindamycin paste, creosote
- Keywords
- periapical periodontitis,primary teeth
- Medical subject headings
- Periapical Diseases, Periapical Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metronidazole-Ciprofloxacin gatifloxacin-Clindamycin pasteDrug
Pulp removal,Root canal irrigation and disinfection,
creosoteDrug
Also called oily liquid obtained by distillation of wood tar
Pulp removal,Root canal irrigation and disinfection
| Study group | Role | What they receive |
|---|---|---|
| creosote | Active comparator | Creosote ，once，three weeks Triple Antibiotic Paste ，none Receives: Drug: creosote |
| Triple Antibiotic Paste | Experimental | Triple Antibiotic Paste,once,three weeks creosote,none Receives: Drug: Metronidazole-Ciprofloxacin gatifloxacin-Clindamycin paste |
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 and X-rays
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2014 (estimated)
- Study startJun 2013
- Primary completionDec 2014 (estimated)
- Study completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Periapical DiseasesStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lin Jiacheng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lin Jiacheng, Sun Yat-sen University
- Investigators
- Jiacheng Lin, Study chair, Guanghua hospital of stomotology,Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02196740
- Sponsor's protocol ID
- Tri-antibiotic-2014
- Status last verified
- Jul 2014
- First submitted
- 17 Jul 2014
- Last updated
- 22 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bezgin T, Yilmaz AD, Celik BN, Sonmez H. Concentrated platelet-rich plasma used in root canal revascularization: 2 case reports. Int Endod J. 2014 Jan;47(1):41-9. doi: 10.1111/iej.12144. Epub 2013 Jun 17.
PubMed 23772873Nagata JY, Gomes BP, Rocha Lima TF, Murakami LS, de Faria DE, Campos GR, de Souza-Filho FJ, Soares Ade J. Traumatized immature teeth treated with 2 protocols of pulp revascularization. J Endod. 2014 May;40(5):606-12. doi: 10.1016/j.joen.2014.01.032. Epub 2014 Mar 6.
PubMed 24767551Nagata JY, Soares AJ, Souza-Filho FJ, Zaia AA, Ferraz CC, Almeida JF, Gomes BP. Microbial evaluation of traumatized teeth treated with triple antibiotic paste or calcium hydroxide with 2% chlorhexidine gel in pulp revascularization. J Endod. 2014 Jun;40(6):778-83. doi: 10.1016/j.joen.2014.01.038. Epub 2014 Apr 29.
PubMed 24862703
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 the Application of Triple Antibiotic Paste in Primary Teeth With
- ClinicalTrials.gov ID
- NCT02196740
- Acronym / sponsor ID
- Tri-antibiotic-2014
- Conditions
- Periapical Diseases
- Keywords
- periapical periodontitis,primary teeth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Lin JiachengUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 22 Jul 2014 (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.
The triple antibiotic paste is widely used in young permanent teeth and permanent teeth root canal therapy with excellent antiantimicrobial effect.We hypothesize that its application in the treatment of periapical periodontitis of deciduous teeth is superior to other drugs currently in use as creosote.
Detailed description
We design to collect a group of patients presenting primary teeth with periapical periodontitis in certain criterion. We will divide the patients into two groups randomly.One group will get treated with triple antibiotic paste while the other with creosote.We want to evaluate the short-term and long-term effects of the two groups to get a conclusion of the clinical value of triple antibiotic paste.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| creosote | Active comparator | Drug: creosoteCreosote ，once，three weeks Triple Antibiotic Paste ，none |
| Triple Antibiotic Paste | Experimental | Drug: Metronidazole-Ciprofloxacin gatifloxacin-Clindamycin pasteTriple Antibiotic Paste,once,three weeks creosote,none |
Who may qualify
- Ages
- 3 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- clinical diagnosis of periapical periodontitis
- must be primary teeth
- must be 3~8 years old
- the permanent tooth germ is complete and didnot be involved
Key exclusion criteria (4 listed)
- blood disease
- residual root that is advised to extract
- serious periodontitis
- allergy to the triple antibiotic paste
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 |
|---|---|---|
| Metronidazole-Ciprofloxacin gatifloxacin-Clindamycin pastePulp removal,Root canal irrigation and disinfection, | Drug | Triple Antibiotic Paste |
| creosoteAlso: oily liquid obtained by distillation of wood tarPulp removal,Root canal irrigation and disinfection | Drug | creosote |
Primary outcome
Evidence of lesion healing confirmed by cone beam computed tomography and X-rays
Time frame: 1 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 23772873Bezgin T, Yilmaz AD, Celik BN, Sonmez H. Concentrated platelet-rich plasma used in root canal revascularization: 2 case reports. Int Endod J. 2014 Jan;47(1):41-9. doi: 10.1111/iej.12144. Epub 2013 Jun 17.
- Background: PubMed 24767551Nagata JY, Gomes BP, Rocha Lima TF, Murakami LS, de Faria DE, Campos GR, de Souza-Filho FJ, Soares Ade J. Traumatized immature teeth treated with 2 protocols of pulp revascularization. J Endod. 2014 May;40(5):606-12. doi: 10.1016/j.joen.2014.01.032. Epub 2014 Mar 6.
- Background: PubMed 24862703Nagata JY, Soares AJ, Souza-Filho FJ, Zaia AA, Ferraz CC, Almeida JF, Gomes BP. Microbial evaluation of traumatized teeth treated with triple antibiotic paste or calcium hydroxide with 2% chlorhexidine gel in pulp revascularization. J Endod. 2014 Jun;40(6):778-83. doi: 10.1016/j.joen.2014.01.038. Epub 2014 Apr 29.
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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.
Jiacheng Lin 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 Metronidazole-Ciprofloxacin gatifloxacin-Clindamycin paste and creosote in people with Periapical Diseases, run by Lin Jiacheng 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 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: 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?
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?
Evidence of lesion healing confirmed by cone beam computed tomography and X-rays (time frame: 1 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 NCT02196740, which also lists 3 linked publications.
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.