Dental CementsNCT00595842
Artificial Root-End Barriers
An observational study of Dental Cements and Tooth Abnormalities, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial summary
This study retrospectively looks to determine the clinical success of ProRoot MTA used as an artificial apical barrier in teeth with immature apices. Read more about this study
- Who is it for?
- Ages 5 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Cements, Tooth Abnormalities
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2007to Jun 2008
- Phase
- Observational
- 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 5 to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Patients between 5-40 years old who have been treated with MTA
Who may be able to join
- a tooth with a single canal and presence of an open apex by radiograph
- Ca(OH)2 treatment for at least one week prior to obturation
- use of MTA to produce an artificial apical barrier
- placement of a final restoration
- radiographs codumenting pretreatment and immedicate post-treatment conditionof the tooth
- patients ages 5-40 years old
Who cannot join
- patients younger than 5 and greater than 40 years old
- patients unable to be contacted for recall during the study
- patients with a medical condition whose health would be jeopardized by participation in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Health Science Center
San Antonio, Texas, 78229
About this study
Official title: Clinical Success of Artificial Root-End Barriers With Mineral Trioxide Aggregate in Teeth With Immature Apices
This study retrospectively looks to determine the clinical success of ProRoot MTA used as an artificial apical barrier in teeth with immature apices.
Read the detailed description
The normal development and maturation of a root depends on a vital, healthy pulp. If the pulp becomes necrotic in a tooth with an immature apex, endodontic treatment can be performed using an artificial barrier technique. Mineral trioxide aggregate (MTA) has become the material of choice to accomplish this procedure, however, few studies have evaluated its clinical success. The purpose of this retrospective study was to determine the clinical success of ProRoot MTA used as an artificial apical barrier. Twenty patients were included in this study. After approximately one week of Ca(OH)2 treatment, each patient had MTA placed as an apical barrier in a tooth with a single canal and open apex followed by placement of a final restoration. Patients were recalled and evaluated for clinical signs and symptoms and osseous healing. Immediate post-treatment and recall radiographs were evaluated by two endodontists calibrated for use of the Periapical Index (PAI).
- Conditions
- Dental Cements, Tooth Abnormalities
- Keywords
- Mineral trioxide aggregate
- Medical subject headings
- Tooth Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group one | Subjects are drawn from a search of all patients treated with MTA between ages 5-40 |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2008 (estimated)
- Study startFeb 2007
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CementsStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- 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
- Collaborators
- 59th Medical Wing
- Responsible party
- Principal investigator, Kenneth Hargreaves, The University of Texas Health Science Center at San Antonio
- Investigators
- David Holden, DMD, Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00595842
- Sponsor's protocol ID
- HSC20070204
- Status last verified
- Mar 2012
- First submitted
- 7 Jan 2008
- Last updated
- 8 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Success of Artificial Root-End Barriers With Mineral Trioxide Aggregate in Teeth With Immature Apices
- ClinicalTrials.gov ID
- NCT00595842
- Acronym / sponsor ID
- HSC20070204
- Conditions
- Dental Cements, Tooth Abnormalities
- Keywords
- Mineral trioxide aggregate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- 59th Medical Wing
- Study start
- Feb 2007
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 16 Jan 2008 (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.
This study retrospectively looks to determine the clinical success of ProRoot MTA used as an artificial apical barrier in teeth with immature apices.
Detailed description
The normal development and maturation of a root depends on a vital, healthy pulp. If the pulp becomes necrotic in a tooth with an immature apex, endodontic treatment can be performed using an artificial barrier technique. Mineral trioxide aggregate (MTA) has become the material of choice to accomplish this procedure, however, few studies have evaluated its clinical success. The purpose of this retrospective study was to determine the clinical success of ProRoot MTA used as an artificial apical barrier. Twenty patients were included in this study. After approximately one week of Ca(OH)2 treatment, each patient had MTA placed as an apical barrier in a tooth with a single canal and open apex followed by placement of a final restoration. Patients were recalled and evaluated for clinical signs and symptoms and osseous healing. Immediate post-treatment and recall radiographs were evaluated by two endodontists calibrated for use of the Periapical Index (PAI).
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group one | – | –Subjects are drawn from a search of all patients treated with MTA between ages 5-40 |
Who may qualify
- Ages
- 5 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Patients between 5-40 years old who have been treated with MTA
Key inclusion criteria (6 listed)
- a tooth with a single canal and presence of an open apex by radiograph
- Ca(OH)2 treatment for at least one week prior to obturation
- use of MTA to produce an artificial apical barrier
- placement of a final restoration
- radiographs codumenting pretreatment and immedicate post-treatment conditionof the tooth
Key exclusion criteria (3 listed)
- patients younger than 5 and greater than 40 years old
- patients unable to be contacted for recall during the study
- patients with a medical condition whose health would be jeopardized by participation 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.
Primary outcome
Not reported in the source record.
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 8 Mar 2012.
Related trials for Dental Cements
Not yet recruiting
Clinical Performance of High Viscous Glass Ionomer Cervical Restorations With Silver-Modified Atraumatic Restorative Technique (SMART) Versus Conventional Treatment in Elderly Cancer Patients. (A 12-month Randomized Clinical Trial)
Dental Caries, Cervical Caries
Recruiting
Evaluation of Ceramic Dental Crown Clinical Performance After Conventional Hydrofluoric Acid Etching or Gaseous Plasma Pretreatment
Prosthodontics, Dental Adhesives/Restorations Performance
Active, not recruiting
Luting Cements for Prefabricated Zirconia Crown Retention in Primary Anterior Teeth in Children
Dental Caries, Tooth Injuries
Not yet recruiting
Repair Versus Replacement of Failed Restorations in Primary Teeth
Dental Caries, Restoration Defects
Not yet recruiting
Predictable Method for Restoring Endodontically Treated Teeth, Comparing Indirect and Direct Methods and Materials in Aesthetic Dentistry.
Endodontically Treated Teeth Requiring Indirect Restorative Treatment
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.
David Holden, DMD principal investigator
University of Texas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Cements and Tooth Abnormalities, 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 6 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 8 Mar 2012. 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.
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.
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 8 Mar 2012.