Pulp NecrosisEarly Phase 1NCT00881491
Treatment Outcome With a Revascularization Protocol Using the Triple Versus Double Antibiotic Paste
A Early Phase 1 study testing Double Antibiotic Paste, Triple Antibiotic Paste and Mineral Trioxide Aggregate in people with Pulp Necrosis, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial summary
The purpose of this study is to determine the treatment outcomes in permanent teeth with necrotic pulp and immature root development that undergo a regenerative procedure using a triple antibiotic paste (ciprofloxacin, metronidazole, minocycline) versus a double antibiotic paste (ciprofloxacin, metronidazole)compared… Read more about this study
- Who is it for?
- Ages 7 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulp Necrosis
- What is being tested?
- Double Antibiotic Paste, Triple Antibiotic Paste and Mineral Trioxide Aggregate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Jan 2015
- Phase
- Early Phase 1
- 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 7 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- diagnosis of pulpal necrosis with apical periodontitis
- patients 7-60 years of age
- maxillary or mandibular restorable single rooted immature permanent tooth with open apices
- acceptance of treatment plan with revascularization procedure
- healthy patient (ASA Class I or II physical status) with no systemic health problems
Who cannot join
- non-restorable teeth
- patients with ASA Class III or IV physical status (Immuno-compromised patients including patients who self-report to be a carrier of HIV, undergoing steroid therapy, or those who self-report with genetic or systemic diseases that could result in reduced immune response.
- child subjects unable to give assent
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
About this study
The purpose of this study is to determine the treatment outcomes in permanent teeth with necrotic pulp and immature root development that undergo a regenerative procedure using a triple antibiotic paste (ciprofloxacin, metronidazole, minocycline) versus a double antibiotic paste (ciprofloxacin, metronidazole)compared to the commonly used mineral trioxide aggregate (MTA) apexification treatment.
Read the detailed description
Recent case series have reported positive outcomes treating necrotic immature permanent teeth with a regenerative procedure using a triple antibiotic paste (ciprofloxacin, metronidazole, minocycline). However, this method can result in considerable staining due to minocycline. In this randomized clinical trial, we will compare clinical outcomes of a triple antibiotic paste versus a double antibiotic paste (ciprofloxacin, metronidazole) intracanal medicament as compared to a standard treatment (immediate apexification with MTA) in permanent teeth with necrotic pulps and immature root development. We hypothesize there will be no significant differences between radiographic measures of root development after treatment with either the double versus triple antibiotic paste, and that both methods will produce significantly greater increases in root length and width compared to standard treatment. The primary outcome measures will be radiographic measurement of root length and dentinal wall thickness and the secondary outcomes will be lack of clinical symptoms and crown staining.
- Conditions
- Pulp Necrosis
- Being tested
- Double Antibiotic Paste, Triple Antibiotic Paste, Mineral Trioxide Aggregate
- Keywords
- Regeneration (revascularization) of dental pulp, Immature permanent tooth with a diagnosis of
- 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.
Double Antibiotic PasteDrug
ciprofloxacin and metronidazole powder mixed at a 1:1 ratio used as a intracanal medicament for disinfection.
Triple Antibiotic PasteDrug
ciprofloxacin, metronidazole \& minocycline mixed to a 1:1:1 powder used as a intracanal medicament for disinfection.
Mineral Trioxide AggregateDrug
standard material providing an apical barrier
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Group A - Double antibiotic paste: intracanal medicament consisting of ciprofloxacin and metronidazole Receives: Drug: Double Antibiotic Paste |
| Group B | Experimental | Group B - Triple Antibiotic Paste: intracanal medicament consisting of ciprofloxacin, metronidazole, minocycline Receives: Drug: Triple Antibiotic Paste |
| Group C | Active comparator | Group C - Mineral trioxide aggregate: used as an apical barrier Receives: Drug: Mineral Trioxide Aggregate |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measures will be radiographic measurement of root length and dentinal wall thickness.
- st radiograph taken at 1 month post-procedure completion
- nd radiograph taken at 3 month post-procedure completion
- rd radiograph taken at 6 month post-procedure completion
Measured: 3 measurements over 6 months
Secondary outcomes (1)
The secondary outcomes will be lack of clinical symptoms and crown staining.
- st clinical assessment done at 1 month post-procedure completion
- nd clinical assessment done at 3 month post-procedure completion
- rd clinical assessment done at 6 month post-procedure completion
Measured: assessed over the 6 month study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionJan 2015
- Study completionJan 2015
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.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center at San Antonio
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kenneth Hargreaves, The University of Texas Health Science Center at San Antonio
- Investigators
- Kenneth M Hargreaves, DDS, PhD, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00881491
- Sponsor's protocol ID
- HSC20090181H
- Status last verified
- Feb 2016
- First submitted
- 13 Apr 2009
- Last updated
- 5 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: No data to be shared
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Outcome With a Revascularization Protocol Using the Triple Versus Double Antibiotic Paste
- ClinicalTrials.gov ID
- NCT00881491
- Acronym / sponsor ID
- HSC20090181H
- Conditions
- Pulp Necrosis
- Keywords
- Regeneration (revascularization) of dental pulp, Immature permanent tooth with a diagnosis of
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 15 Apr 2009 (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 purpose of this study is to determine the treatment outcomes in permanent teeth with necrotic pulp and immature root development that undergo a regenerative procedure using a triple antibiotic paste (ciprofloxacin, metronidazole, minocycline) versus a double antibiotic paste (ciprofloxacin, metronidazole)compared to the commonly used mineral trioxide aggregate (MTA) apexification treatment.
Detailed description
Recent case series have reported positive outcomes treating necrotic immature permanent teeth with a regenerative procedure using a triple antibiotic paste (ciprofloxacin, metronidazole, minocycline). However, this method can result in considerable staining due to minocycline. In this randomized clinical trial, we will compare clinical outcomes of a triple antibiotic paste versus a double antibiotic paste (ciprofloxacin, metronidazole) intracanal medicament as compared to a standard treatment (immediate apexification with MTA) in permanent teeth with necrotic pulps and immature root development. We hypothesize there will be no significant differences between radiographic measures of root development after treatment with either the double versus triple antibiotic paste, and that both methods will produce significantly greater increases in root length and width compared to standard treatment. The primary outcome measures will be radiographic measurement of root length and dentinal wall thickness and the secondary outcomes will be lack of clinical symptoms and crown staining.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: Double Antibiotic PasteGroup A - Double antibiotic paste: intracanal medicament consisting of ciprofloxacin and metronidazole |
| Group B | Experimental | Drug: Triple Antibiotic PasteGroup B - Triple Antibiotic Paste: intracanal medicament consisting of ciprofloxacin, metronidazole, minocycline |
| Group C | Active comparator | Drug: Mineral Trioxide AggregateGroup C - Mineral trioxide aggregate: used as an apical barrier |
Who may qualify
- Ages
- 7 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- diagnosis of pulpal necrosis with apical periodontitis
- patients 7-60 years of age
- maxillary or mandibular restorable single rooted immature permanent tooth with open apices
- acceptance of treatment plan with revascularization procedure
- healthy patient (ASA Class I or II physical status) with no systemic health problems
Key exclusion criteria (3 listed)
- non-restorable teeth
- patients with ASA Class III or IV physical status (Immuno-compromised patients including patients who self-report to be a carrier of HIV, undergoing steroid therapy, or those who self-report with genetic or systemic diseases that could result in reduced immune response.
- child subjects unable to give assent
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 |
|---|---|---|
| Double Antibiotic Pasteciprofloxacin and metronidazole powder mixed at a 1:1 ratio used as a intracanal medicament for disinfection. | Drug | Group A |
| Triple Antibiotic Pasteciprofloxacin, metronidazole \& minocycline mixed to a 1:1:1 powder used as a intracanal medicament for disinfection. | Drug | Group B |
| Mineral Trioxide Aggregatestandard material providing an apical barrier | Drug | Group C |
Primary outcome
The primary outcome measures will be radiographic measurement of root length and dentinal wall thickness.
Time frame: 3 measurements over 6 months
1. st radiograph taken at 1 month post-procedure completion 2. nd radiograph taken at 3 month post-procedure completion 3. rd radiograph taken at 6 month post-procedure completion
1 secondary outcome
The secondary outcomes will be lack of clinical symptoms and crown staining.
Time frame: assessed over the 6 month study period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2016.
- Individual participant dataSharing planned: No. No data to be shared
Related trials for Pulp Necrosis
Recruiting
Conventional and Nano-Metronidazole Irrigation With/Without Activation in Necrotic Teeth With Apical Periodontitis
Pulp Necrosis, Apical Periodontitis
Not yet recruiting
The Effect of Bitewing Radiography on Outcomes and Costs of Treating Caries in Permanent Teeth
Dental Caries, Teeth Loss
Recruiting
One vs Two Visits Root Canal Treatments in Infected Teeth
Apical Periodontitis, Pain
Active, not recruiting
Effect of Apical Patency on Periapical Lesion Healing
Periapical Lesion, Apical Periodontitis
Active, not recruitingObservational study
Lesion Sterilization Tissue Repair and Conventional Pulpectomy in Primary Molars
Pulpitis - Irreversible, Pulp Necroses
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.
Kenneth M Hargreaves, DDS, PhD principal investigator
The University of Texas Health Science Center at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Double Antibiotic Paste, Triple Antibiotic Paste and Mineral Trioxide Aggregate in people with Pulp Necrosis, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
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 5 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: finished, as of the sponsor's last update on 5 Feb 2016. 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 United States. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The primary outcome measures will be radiographic measurement of root length and dentinal wall thickness. (time frame: 3 measurements over 6 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 5 Feb 2016.