Periapical PeriodontitisRanoKureNCT03102879
Encapsulated Mesenchymal Stem Cells for Dental Pulp Regeneration.
A study testing Regenerative Endodontic Procedure and Conventional Root Canal Treatment in people with Periapical Periodontitis, run by Universidad de los Andes, Chile at 1 site in Chile.
Trial summary
To compare the dental survival in a period of one year of mature permanent teeth with apical lesion following the administration of encapsulated Mesenchymal Stem Cells under a regenerative endodontic procedure and a conventional root canal treatment. Read more about this study
- Who is it for?
- Ages 16 to 58 years
- Conditions the study is for
- Periapical Periodontitis
- What is being tested?
- Regenerative Endodontic Procedure and Conventional Root Canal Treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChile
- Study dates
- 23 Sep 2016to 30 Sep 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 16 to 58 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patient inclusion criteria:
- Age: 16 - 58 years old.
- Signed the informed consent.
- Non-smoking.
- Systemically healthy patients
- Tooth inclusion criteria:
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- Upper and lower incisors, upper and lower canines and lower premolars teeth with mature apex and apical lesion (greater than 2 PAI and 1 CBCTPAI).
- Teeth that do not response to both electrical and thermal pulp test
- Teeth that can be restored (as defined by Class A or Class B using Samet and Jotkowitz classification) without the need of a stainless steel crown.
Who cannot join
- Patient exclusion criteria:
- Patients without a phone number for contact during the study.
- Subjects not available for follow up period (12 months).
- Patients who are or will undergo orthodontic treatment over the next 12 months.
- Patients with an allergy to any material or drug used in the study.
- Patients who are pregnant or lactating.
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- Patients with a history of systemic diseases that alter immune function, such as diabetes mellitus, immunodeficiency, leukemia, Addison's disease and Cushing.
- Patients who have used immunosuppressive drugs or chemotherapy, 3 months before the study.
- Tooth exclusion criteria:
- Endodontically treated teeth
- Teeth with signs of severe root resorption.
- Teeth with mobility class III or Dens invaginatus.
- Teeth with avulsion history and conservation in a dry extraoral medium for more than 1 hour.
- Teeth with clinical and / or radiographic evidence of root fracture.
- Teeth that can not be absolutely isolated with rubber dam. . Teeth with more than one root or root canal.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Encapsulated Mesenchymal Stem Cells for Endodontic Treatment of Permanent Teeth With Apical Lesion: a Controlled Clinical Trial.
To compare the dental survival in a period of one year of mature permanent teeth with apical lesion following the administration of encapsulated Mesenchymal Stem Cells under a regenerative endodontic procedure and a conventional root canal treatment.
Read the detailed description
This is a controlled clinical trial designed to evaluate the survival of mature permanent teeth with apical lesion treated with regenerative endodontic procedure (REP) based on encapsulated Mesenchymal Stem Cells in a biological scaffold. The REP will be compared to the conventional endodontic therapy. The REP is based on the use of umbilical cord-derived mesenchymal stem cells encapsulated in a plasma-derived biomaterial . The study group will use the disinfection protocol, indicated in the clinical considerations for regenerative procedures as recommended by the American Association of Endodontics, using a paste of calcium hydroxide prepared with double-distilled water as intracanal medication, and will be operated with REP using allogeneic stem cells in a scaffold, while the control group will be operated with conventional endodontic therapy alone. This clinical trial pretends to determine the dental survival of the tooth with mature apex and apical lesion, over a period of one year.
- Conditions
- Periapical Periodontitis
- Being tested
- Regenerative Endodontic Procedure, Conventional Root Canal Treatment
- Keywords
- mesenchymal stem cells, regenerative procedures, tissue engineering, regenerative endodontic, scaffold, cell encapsulation, dental pulp, pulp regeneration, plasma-derived biomaterial, allogenic stem cells, mesenchymal stromal cells, adult stem cells, umbilical cord stem cells
- Medical subject headings
- Periapical Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regenerative Endodontic ProcedureProcedure or surgery
Also called REP, Tissue engineering procedure
Coronary access, conductometry, mechanized instrumentation, irrigation with sodium hypochlorite, intracanal calcium hydroxide medication and obturation with stem cells.
Conventional Root Canal TreatmentProcedure or surgery
Also called Gold standard treatment
Coronary access, conductometry, mechanized instrumentation, irrigation with sodium hypochlorite, intracanal calcium hydroxide medication and obturation with gutta-percha.
| Study group | Role | What they receive |
|---|---|---|
| Regenerative Endodontic Procedure (REP) | Experimental | umbilical cord-derived mesenchymal stem cells encapsulated in a plasma-derived biomaterial. Receives: Procedure: Regenerative Endodontic Procedure |
| Conventional Root Canal Treatment | Active comparator | Conventional endodontic procedure Receives: Procedure: Conventional Root Canal Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participats Showing Efficacy (Functionality)
Efficacy (functionality) was defined when one year after the intervention, the treated tooth remains in the mouth, without pain to percussion test and with apical bone lesion of equal size in the three senses of space or a decrease in some of them or no more than 0.1 mm increase of one of them.
Measured: 12 months
Secondary outcomes (5)
Change in Pulpal Response
Change in pulpal response (period 1 year) will be assessed through response to sensitivity tests (cold, hot and electrical test) in teeth treated with regenerative procedure and conventional endodontic treatment during time.
Measured: baseline, 6 months, 12 months
Change in Apical Lesion Size
Change in apical lesion size will be evaluated by cone beam tomography 6 and 12 months after intervention is completed.
Measured: baseline, 6 months, 12 months
Pain to Percussion
To compare pain to percussion in a period of 1 year in permanent teeth with mature apex and apical lesion, treated with a regenerative endodontic procedure and conventional endodontic therapy.
This will be monitored 6 and 12 months after the procedure is completed.
Pain to percussion positive: The tooth is tenderness when is softly tapped with handle end of a dental mirror at examination time.
Pain to percussion negative: The tooth is not tenderness when is softly tapped with handle end of a dental mirror at examination time.
Measured: baseline, 6 months, 12 months
Numbers of Participants With Adverse Event
To describe adverse events in a period of 1 year in permanent teeth with mature apex and apical lesion, operated with a regenerative endodontic procedure and conventional endodontic therapy.
Measured: 6 months, 12 months
Pulp Regeneration
To describe the pulp regeneration by means of vitality test using Doppler laser flowmetry (LDF) in a period of 1 year in permanent teeth with mature apex and apical lesion treated with a regenerative endodontic procedure.
The vitality of the teeth was measured by LDF and the perfusion units (PU) percentage of the tooth under study was determined with respect to a healthy control tooth with similar anatomical characteristics from the same patient.
Measured: baseline, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2017
- Study start23 Sep 2016
- Primary completion30 Sep 2018
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Model description
- 2 interventions: 1. Endodontic regenerative treatment with Biological product of umbilical cord-derived mesenchymal stem cells encapsulated in a plasma-derived biomaterial. 2. Endodontic treatment with inert product gutapercha.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de los Andes, Chile
- Sponsor type
- University, hospital or other
- Collaborators
- Cells for Cells
- Responsible party
- Principal investigator, Dra. Claudia Brizuel, Universidad de los Andes, Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03102879
- Sponsor's protocol ID
- RPD-8-16
- Acronym
- RanoKure
- Status last verified
- Jan 2020
- First submitted
- 21 Mar 2017
- Last updated
- 21 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Brizuela C, Meza G, Urrejola D, Quezada MA, Concha G, Ramirez V, Angelopoulos I, Cadiz MI, Tapia-Limonchi R, Khoury M. Cell-Based Regenerative Endodontics for Treatment of Periapical Lesions: A Randomized, Controlled Phase I/II Clinical Trial. J Dent Res. 2020 May;99(5):523-529. doi: 10.1177/0022034520913242. Epub 2020 Mar 23.
PubMed 32202965
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Encapsulated Mesenchymal Stem Cells for Endodontic Treatment of Permanent Teeth With Apical Lesion: a Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT03102879
- Acronym / sponsor ID
- RanoKure / RPD-8-16
- Conditions
- Periapical Periodontitis
- Keywords
- mesenchymal stem cells, regenerative procedures, tissue engineering, regenerative endodontic, scaffold, cell encapsulation, dental pulp, pulp regeneration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Universidad de los Andes, ChileUniversity, hospital or other
- Collaborators
- Cells for Cells
- Study start
- 23 Sep 2016 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 6 Apr 2017 (actual)
- Results
- Posted 21 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the dental survival in a period of one year of mature permanent teeth with apical lesion following the administration of encapsulated Mesenchymal Stem Cells under a regenerative endodontic procedure and a conventional root canal treatment.
Detailed description
This is a controlled clinical trial designed to evaluate the survival of mature permanent teeth with apical lesion treated with regenerative endodontic procedure (REP) based on encapsulated Mesenchymal Stem Cells in a biological scaffold. The REP will be compared to the conventional endodontic therapy. The REP is based on the use of umbilical cord-derived mesenchymal stem cells encapsulated in a plasma-derived biomaterial . The study group will use the disinfection protocol, indicated in the clinical considerations for regenerative procedures as recommended by the American Association of Endodontics, using a paste of calcium hydroxide prepared with double-distilled water as intracanal medication, and will be operated with REP using allogeneic stem cells in a scaffold, while the control group will be operated with conventional endodontic therapy alone. This clinical trial pretends to determine the dental survival of the tooth with mature apex and apical lesion, over a period of one year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 2 interventions: 1. Endodontic regenerative treatment with Biological product of umbilical cord-derived mesenchymal stem cells encapsulated in a plasma-derived biomaterial. 2. Endodontic treatment with inert product gutapercha.
| Arm | Type | Receives |
|---|---|---|
| Regenerative Endodontic Procedure (REP) | Experimental | Procedure: Regenerative Endodontic Procedureumbilical cord-derived mesenchymal stem cells encapsulated in a plasma-derived biomaterial. |
| Conventional Root Canal Treatment | Active comparator | Procedure: Conventional Root Canal TreatmentConventional endodontic procedure |
Who may qualify
- Ages
- 16 to 58 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Age: 16 - 58 years old.
- Signed the informed consent.
- Non-smoking.
- Systemically healthy patients
- Upper and lower incisors, upper and lower canines and lower premolars teeth with mature apex and apical lesion (greater than 2 PAI and 1 CBCTPAI).
Key exclusion criteria (15 listed)
- Patients without a phone number for contact during the study.
- Subjects not available for follow up period (12 months).
- Patients who are or will undergo orthodontic treatment over the next 12 months.
- Patients with an allergy to any material or drug used in the study.
- Patients who are pregnant or lactating.
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 |
|---|---|---|
| Regenerative Endodontic ProcedureAlso: REP, Tissue engineering procedureCoronary access, conductometry, mechanized instrumentation, irrigation with sodium hypochlorite, intracanal calcium hydroxide medication and obturation with stem cells. | Procedure or surgery | Regenerative Endodontic Procedure (REP) |
| Conventional Root Canal TreatmentAlso: Gold standard treatmentCoronary access, conductometry, mechanized instrumentation, irrigation with sodium hypochlorite, intracanal calcium hydroxide medication and obturation with gutta-percha. | Procedure or surgery | Conventional Root Canal Treatment |
Primary outcome
Number of Participats Showing Efficacy (Functionality)
Time frame: 12 months
Efficacy (functionality) was defined when one year after the intervention, the treated tooth remains in the mouth, without pain to percussion test and with apical bone lesion of equal size in the three senses of space or a decrease in some of them or no more than 0.1 mm increase of one of them.
5 secondary outcomes
Change in Pulpal Response
Time frame: baseline, 6 months, 12 months
Change in Apical Lesion Size
Time frame: baseline, 6 months, 12 months
Pain to Percussion
Time frame: baseline, 6 months, 12 months
Numbers of Participants With Adverse Event
Time frame: 6 months, 12 months
Pulp Regeneration
Time frame: baseline, 6 months, 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32202965Brizuela C, Meza G, Urrejola D, Quezada MA, Concha G, Ramirez V, Angelopoulos I, Cadiz MI, Tapia-Limonchi R, Khoury M. Cell-Based Regenerative Endodontics for Treatment of Periapical Lesions: A Randomized, Controlled Phase I/II Clinical Trial. J Dent Res. 2020 May;99(5):523-529. doi: 10.1177/0022034520913242. Epub 2020 Mar 23.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Regenerative Endodontic Procedure and Conventional Root Canal Treatment in people with Periapical Periodontitis, run by Universidad de los Andes, Chile at 1 site in Chile.
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 9 inclusion and 15 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 21 Jan 2020. 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 Chile. 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?
Yes. Results are posted in the registry (first posted 21 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participats Showing Efficacy (Functionality) (time frame: 12 months). 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 NCT03102879, 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 21 Jan 2020.