Dental Pulp RegenerationPhase 1NCT01805388
Comparison of Tissue in Regenerative Endodontic Procedures and Apexification
A Phase 1 study testing Experimental: Regeneration Treatment Group in people with Dental Pulp Regeneration, run by Kenneth Hargreaves at 1 site in United States.
Trial summary
The purpose of our study is to characterize the composition of the hard and soft tissues present after regenerative endodontic procedures in root canals of teeth previously diagnosed with the need for extraction for orthodontic treatment and incomplete root formation. Read more about this study
- Who is it for?
- Ages 9 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Pulp Regeneration
- What is being tested?
- Experimental: Regeneration Treatment Group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Oct 2015
- Phase
- 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 9 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patient Inclusion Criteria:
- Children ages 9-18 with bilateral premolars with incomplete root development scheduled for extraction for orthodontic reasons.
- Children who seem to be cooperative with dental treatment and able to indicate willingness to obtain treatment and participate in the study and who are capable of verbally expressing dissent.
- Parents who express understanding of study treatments and consent to treatment for their child of the regenerative procedure prior to the tooth extraction for orthodontic reasons .
- Healthy patients (ASA Class I or II physical status) with no systemic health problems that may interfere with healing and cell growth.
- Tooth inclusion criteria:
- Permanent premolar teeth with immature root development and healthy pulps scheduled for extraction due to orthodontic requirements.
- Clinically confirmed teeth with good periodontal health assessed by periodontal probing depths of less than 4mm.
Who cannot join
- Patient Exclusion Criteria:
- Parents and patients unable to give consent or express dissent.
- Patients who are unwilling to undergo the research and orthodontic dental treatment.
- Patients affected by tempromandibular joint disorders.
- Patients affected by known orofacial pain disorders.
- Patients with ASA Class III or IV physical status (Immuno-compromised patients including patients who self-report that they are an HIV carrier, undergoing steroid therapy or chemotherapy, or those who self-report with genetic or systemic diseases that could result in reduced immune response).
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- Tooth Exclusion Criteria:
- Teeth with vertical cracks that extend below the cemento-enamel junction.
- Teeth that cannot be isolated using a rubber dam.
- Teeth with non-odontogenic pathology.
- Teeth whose apices are fully developed, as determined radiographically and correlated with dental age of patient.
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: Comparison of Tissue Formation in Regenerative Endodontic Procedures and Apexification
The purpose of our study is to characterize the composition of the hard and soft tissues present after regenerative endodontic procedures in root canals of teeth previously diagnosed with the need for extraction for orthodontic treatment and incomplete root formation. Although the protocol addressed in this study is currently being used in clinical practice, there are no prospective clinical trials investigating its efficacy in stimulating continued root development and the nature of the newly formed tissues.
Read the detailed description
Twenty subjects with permanent bilateral premolar teeth with incomplete root development and scheduled for extraction due to orthodontic requirement will be treated with a regeneration protocol. Teeth (n=20/group) will be extracted at 3 months following the regenerative protocol or the pulpectomy control. The protocol relies on disinfection of the canal space by copious irrigation with common endodontic irrigants and placement of a triple antibiotic paste (regenerative group) or calcium hydroxide dressing (control group) to disinfect the root for a period of one month. In each patient, both treatment arms will be performed. Thus, each treatment sample will have a contralateral matching control (paired designs). At the end of one month, the intracanal medicaments (triple antibiotic paste) is irrigated out of the canal and a blood clot is stimulated in the canal with the aid of endodontic files that are introduced into the periapical tissues; this blood clot will serve as a scaffold for tissue proliferation within the canal. The regenerative treatment tooth is then restored to prevent bacteria from the oral cavity from re-contaminating the canal space. For the contralateral control tooth, the medication will remain in the tooth until the extraction date. The subjects in this study will have the treated teeth extracted at 3 months after initial treatment. The extracted teeth from each study participant will be placed in storage medium until Immunohistochemical analysis with antibodies to characterize the tissue/cells within the canal.
- Conditions
- Dental Pulp Regeneration
- Being tested
- Experimental: Regeneration Treatment Group, Control Non-Study Drug Group
- Keywords
- Dental Pulp Regeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: Regeneration Treatment GroupDrug
Also called Regenerative RTC using Triple Antibiotic Paste study drug
Regenerative Root Canal Therapy using Triple Antibiotic Paste study drug
Control Non-Study Drug GroupProcedure or surgery
Also called Root Canal Therapy
Endodontic RTC with no study drug
| Study group | Role | What they receive |
|---|---|---|
| Regeneration Treatment Group | Experimental | RTC with Triple Antibiotic Study Drug Receives: Drug: Experimental: Regeneration Treatment Group; Procedure: Control Non-Study Drug Group |
| Control Non-study Drug Group | No intervention | RTC on contralateral tooth with no study drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histological identification of the mineralized tissue at the apical third of the root and the adherent cellular layer.
Although we predict histological identification of dentin/odontoblasts (due to the proximity of the apical papilla and associated SCAP stem cells) using our scanning laser confocal microscopy system, our methods are sufficiently sensitive to permit identification of bone/osteoblasts and cementum/cementoblasts as alternative hypotheses.
Measured: Following tooth extraction at the 3 month followup visit. Correlation of all data collected from the extracted teeth will occur at the completion of the study at year 5.
Secondary outcomes (1)
Whether stem cells enter the canal space when bleeding is stimulated through manipulation of the apical papilla.
This secondary outcome measure will be conducted by measuring markers of stem cells prior to and after the formation of the blood clot. We predict that evoking bleeding into the root canal system will increase the delivery of mesenchymal stem cells.
Measured: Canal bleeding is evoked during the second treatment visit thirty days following the first treatment. Blood collected by paper points will be saved till the end of the study (year 5) for analysis.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2013 (estimated)
- Study startFeb 2013
- Primary completionOct 2015
- Study completionOct 2015
Why it stopped: Lack of pediatric recruitment ability
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 Dental Pulp RegenerationStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kenneth Hargreaves
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kenneth Hargreaves, The University of Texas Health Science Center at San Antonio
- Investigators
- Anibal R Diogenes, DDS, PhD, Principal investigator, The University of Texas Health Science Center at San AntonioDubravko Pavlin, DMD, PhD, Principal investigator, The University of Texas Health Science Center at San AntonioKenneth M Hargreaves, DDS, PhD, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01805388
- Sponsor's protocol ID
- HSC20130054H
- Status last verified
- Feb 2016
- First submitted
- 28 Feb 2013
- Last updated
- 5 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Thibodeau B. Case report: pulp revascularization of a necrotic, infected, immature, permanent tooth. Pediatr Dent. 2009 Mar-Apr;31(2):145-8.
PubMed 19455934
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
- Comparison of Tissue Formation in Regenerative Endodontic Procedures and Apexification
- ClinicalTrials.gov ID
- NCT01805388
- Acronym / sponsor ID
- HSC20130054H
- Conditions
- Dental Pulp Regeneration
- Keywords
- Dental Pulp Regeneration
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of pediatric recruitment ability
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Kenneth HargreavesUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 6 Mar 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.
The purpose of our study is to characterize the composition of the hard and soft tissues present after regenerative endodontic procedures in root canals of teeth previously diagnosed with the need for extraction for orthodontic treatment and incomplete root formation. Although the protocol addressed in this study is currently being used in clinical practice, there are no prospective clinical trials investigating its efficacy in stimulating continued root development and the nature of the newly formed tissues.
Detailed description
Twenty subjects with permanent bilateral premolar teeth with incomplete root development and scheduled for extraction due to orthodontic requirement will be treated with a regeneration protocol. Teeth (n=20/group) will be extracted at 3 months following the regenerative protocol or the pulpectomy control. The protocol relies on disinfection of the canal space by copious irrigation with common endodontic irrigants and placement of a triple antibiotic paste (regenerative group) or calcium hydroxide dressing (control group) to disinfect the root for a period of one month. In each patient, both treatment arms will be performed. Thus, each treatment sample will have a contralateral matching control (paired designs). At the end of one month, the intracanal medicaments (triple antibiotic paste) is irrigated out of the canal and a blood clot is stimulated in the canal with the aid of endodontic files that are introduced into the periapical tissues; this blood clot will serve as a scaffold for tissue proliferation within the canal. The regenerative treatment tooth is then restored to prevent bacteria from the oral cavity from re-contaminating the canal space. For the contralateral control tooth, the medication will remain in the tooth until the extraction date. The subjects in this study will have the treated teeth extracted at 3 months after initial treatment. The extracted teeth from each study participant will be placed in storage medium until Immunohistochemical analysis with antibodies to characterize the tissue/cells within the canal.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regeneration Treatment Group | Experimental | Drug: Experimental: Regeneration Treatment Group, Procedure: Control Non-Study Drug GroupRTC with Triple Antibiotic Study Drug |
| Control Non-study Drug Group | No intervention | –RTC on contralateral tooth with no study drug |
Who may qualify
- Ages
- 9 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Children ages 9-18 with bilateral premolars with incomplete root development scheduled for extraction for orthodontic reasons.
- Children who seem to be cooperative with dental treatment and able to indicate willingness to obtain treatment and participate in the study and who are capable of verbally expressing dissent.
- Parents who express understanding of study treatments and consent to treatment for their child of the regenerative procedure prior to the tooth extraction for orthodontic reasons .
- Healthy patients (ASA Class I or II physical status) with no systemic health problems that may interfere with healing and cell growth.
- Permanent premolar teeth with immature root development and healthy pulps scheduled for extraction due to orthodontic requirements.
Key exclusion criteria (11 listed)
- Parents and patients unable to give consent or express dissent.
- Patients who are unwilling to undergo the research and orthodontic dental treatment.
- Patients affected by tempromandibular joint disorders.
- Patients affected by known orofacial pain disorders.
- Patients with ASA Class III or IV physical status (Immuno-compromised patients including patients who self-report that they are an HIV carrier, undergoing steroid therapy or chemotherapy, or those who self-report with genetic or systemic diseases that could result in reduced immune response).
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 |
|---|---|---|
| Experimental: Regeneration Treatment GroupAlso: Regenerative RTC using Triple Antibiotic Paste study drugRegenerative Root Canal Therapy using Triple Antibiotic Paste study drug | Drug | Regeneration Treatment Group |
| Control Non-Study Drug GroupAlso: Root Canal TherapyEndodontic RTC with no study drug | Procedure or surgery | Regeneration Treatment Group |
Primary outcome
Histological identification of the mineralized tissue at the apical third of the root and the adherent cellular layer.
Time frame: Following tooth extraction at the 3 month followup visit. Correlation of all data collected from the extracted teeth will occur at the completion of the study at year 5.
Although we predict histological identification of dentin/odontoblasts (due to the proximity of the apical papilla and associated SCAP stem cells) using our scanning laser confocal microscopy system, our methods are sufficiently sensitive to permit identification of bone/osteoblasts and cementum/cementoblasts as alternative hypotheses.
1 secondary outcome
Whether stem cells enter the canal space when bleeding is stimulated through manipulation of the apical papilla.
Time frame: Canal bleeding is evoked during the second treatment visit thirty days following the first treatment. Blood collected by paper points will be saved till the end of the study (year 5) for analysis.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2016.
- Background: PubMed 19455934Thibodeau B. Case report: pulp revascularization of a necrotic, infected, immature, permanent tooth. Pediatr Dent. 2009 Mar-Apr;31(2):145-8.
Related trials for Dental Pulp Regeneration
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Effect of Different NanoScaffolds on Pulp Regeneration in Non-Vital Immature Permanent Teeth (Randomized Clinical Trial)
Necrotic Immature Permanent Incisors
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Role of GTR on Healing Outcome & Quality of Life in Combined Endo Perio Lesions With Communication
Periapical Diseases, Endodontic Disease
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.
Anibal R Diogenes, DDS, PhD principal investigator
The University of Texas Health Science Center at San Antonio
Dubravko Pavlin, DMD, PhD principal investigator
The University of Texas Health Science Center at San Antonio
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 Phase 1 study testing Experimental: Regeneration Treatment Group in people with Dental Pulp Regeneration, run by Kenneth Hargreaves 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 8 inclusion and 11 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: withdrawn, 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 was withdrawn before enrolling participants, so there are no results.
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?
Histological identification of the mineralized tissue at the apical third of the root and the adherent cellular layer. (time frame: Following tooth extraction at the 3 month followup visit. Correlation of all data collected from the extracted teeth will occur at the completion of the study at year 5.). 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 NCT01805388, 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 5 Feb 2016.