Periapical DiseasesCARETTNCT05305417
Cell-free Autologous Regenerative Endodontics Treatment for Teeth With Periapical Lesions (CARETT)
A study testing Autologous Regenerative Endodontic Treatment and Conventional Root Canal Treatment in people with Periapical Diseases and Pulp Necroses, run by Universidad de Valparaiso.
Trial summary
Conventional endodontic treatment has been the treatment of choice for the management of signs and symptoms of mature permanent teeth with pulpal necrosis and periapical lesion with predictable and favorable results. However, treatment outcomes have not shown improvement or innovation in decades. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Periapical Diseases, Pulp Necroses
- What is being tested?
- Autologous Regenerative Endodontic Treatment 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
- 228 participants
- Where
- No sites listed yet
- Study dates
- Mar 2023to Mar 2025
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female (18-60y) systemically healthy or chronic disease controlled
- Uniradicular or multiradicular permanent mature teeth
- Teeth with diagnosis of pulp necrosis (negative response to thermal-cold pulp test) and sings or symptoms (clinical-radiographic) of periapical lesion.
- Root anatomy with curvatures ≤ 30°
- Feasibility of adhesive tooth restoration (direct or indirect)
- Voluntary participation under informed consent
Who cannot join
- Pregnant or lactating woman
- Signs of moderate or severe periodontal disease
- Teeth with signs of radicular fracture (vertical or horizontal), signs of root resorption (endo-exo)
- teeth with impossibility of good prognosis of coronary rehabilitation by direct or indirect adhesive technique
- Teeth that to treat can not to be correctly isolate with rubber dam
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Cell-free Autologous Regenerative Endodontics Treatment for Permanent Mature Teeth With Pulp Necrosis and Periapical Lesions: a Randomized, Controlled Phase III Clinical Trial (CARETT)
Conventional endodontic treatment has been the treatment of choice for the management of signs and symptoms of mature permanent teeth with pulpal necrosis and periapical lesion with predictable and favorable results. However, treatment outcomes have not shown improvement or innovation in decades. The main objective of this study is to evaluate the clinical effectiveness of a regenerative endodontic procedure (cell-free and autologous protocol) versus conventional endodontics in the resolution of signs and symptoms of periapical lesion and pulp vitality-sensitivity in mature permanent teeth with a diagnosis of pulpal necrosis and periapical lesion.
Read the detailed description
Conventional endodontic treatment has been an effective treatment option for decades to treat signs and symptoms in mature permanent teeth with a diagnosis of apical lesion due to pulpal necrosis, allowing the teeth to be kept in the mouth free of signs/symptoms but devitalized. The clinical effectiveness of conventional treatment in this type of case is ≥80%, with some variations according to different studies. Despite advances and modifications in treatment protocols, this therapy has not shown improvements or innovations in its results in recent decades. The Regenerative Endodontics alternative is postulated as a biologically based endodontic treatment option that allows to resolve the signs and symptoms along with dental revitalization through the regeneration of the pulpal connective tissue, generating a substantive possibility of innovation and improvements to the therapy of conventional endodontics.
Various regenerative endodontic protocols have been proposed to achieve pulp tissue regeneration, from sophisticated techniques that involve cell transplantation, provision of scaffolds and/or signaling molecules, or simpler protocols that appeal to the autologous capacity of the organism to regenerate tissue. lost.
The main objective of this study is to evaluate the clinical effectiveness of a cell-free regenerative endodontic procedure with the contribution of an autologous scaffold (L-PRF) versus conventional endodontics in the recovery of signs of periapical lesion and pulp vitality-sensitivity in mature permanent teeth with diagnosis of pulpal necrosis and periapical lesion.
- Conditions
- Periapical Diseases, Pulp Necroses
- Being tested
- Autologous Regenerative Endodontic Treatment, Conventional Root Canal Treatment
- Keywords
- Regenerative Endodontics, Permanent Dentition, Pulp Necroses, Periapical Diseases, Root Canal Filling Material
- Medical subject headings
- Periapical Diseases, Dental Pulp Necrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Regenerative Endodontic TreatmentProcedure or surgery
Also called Pulp revascularization, Pulp revitalization, Pulp regeneration
The intervention consist in achieve an access to the teeth root canal system, do a chemico-mechanical preparation each root canal for to be obturated with an autologous biological scaffold and bioactive biomaterials to maintain teeth free of signs/symptoms caused by pulp necroses and periapical lesions
Conventional Root Canal TreatmentProcedure or surgery
Also called Endodontically-treated Teeth
The intervention consist in achieve an access to the teeth root canal system, do a chemico-mechanical preparation each root canal for to be obturated with an inert biomaterial to maintain teeth free of signs/symptoms caused by pulp necroses and periapical lesions
| Study group | Role | What they receive |
|---|---|---|
| Regenerative Endodontic Treatment | Experimental | This treatment consists of obturated the root canal preparations under an biological-based protocol using autologous biological elements and bioactive materials that allows restore the connective pulp-like tissue within the canals. Receives: Procedure: Autologous Regenerative Endodontic Treatment |
| Conventional root canal treatment | Active comparator | This treatment consist on obturated the root canal preparations under the conventional protocol with an inert biomaterials like guttapercha and endodontics cements to seal the root canals. Receives: Procedure: Conventional Root Canal Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of therapy
Number of treated tooth that remain in mouth free of clinical (negative percussion, negative palpation, abscence of inflammation, pain and fistula) and radiographic (total or partial reduction on size of periapical lesion) signs or symptoms at 12 month post operatory.
Measured: 12 month
Secondary outcomes (4)
Tooth re-sensibilization
Number of treated tooth that response positively to thermal pulp sensibility test (cold stimulus) after 3, 6 and 12 months post operatory in relation with the initial negative pulp test. The positive-negative pulp sensibility response of treated teeth first is standardized testing the homologous vital tooth on the mouth.
Measured: 3, 6 and 12 month
Tooth re-vitalization
Number of treated tooth that response positively to Vitality Pulp Test Doppler laser flowmetry after 3, 6 and 12 month. This Vitality Test assess pulpal blood flow by the detection of light scatter generated by moving erythrocytes. The positive-negative pulp vitality response of the treated teeth first is standardized testing the homologous vital tooth on the mouth.
Measured: 3, 6 and 12 month
Periapical lesion resolution
Resolution of an periapical lesion using Periapical Index (PI), a scoring system for registration of apical periodontitis in radiographs
Measured: 3, 6 and 12 month
Procedure Time
total time required to perform each of the therapies recorded in minutes
Measured: intraoperatory
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study startMar 2023 (estimated)
- Primary completionMar 2024 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 228 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Valparaiso
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alicia Caro, MSC, DDS, Study director, Department of Endodontics, Faculty of Dentistry, University of Valparaíso, Chile.Juan Caro, DDS, Principal investigator, Department of Endodontics, Faculty of Dentistry, University of Valparaíso, Chile.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05305417
- Sponsor's protocol ID
- 211
- Acronym
- CARETT
- Status last verified
- Mar 2022
- First submitted
- 22 Mar 2022
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Publications
Glynis A, Foschi F, Kefalou I, Koletsi D, Tzanetakis GN. Regenerative Endodontic Procedures for the Treatment of Necrotic Mature Teeth with Apical Periodontitis: A Systematic Review and Meta-analysis of Randomized Controlled Trials. J Endod. 2021 Jun;47(6):873-882. doi: 10.1016/j.joen.2021.03.015. Epub 2021 Mar 31.
PubMed 33811981Marquis VL, Dao T, Farzaneh M, Abitbol S, Friedman S. Treatment outcome in endodontics: the Toronto Study. Phase III: initial treatment. J Endod. 2006 Apr;32(4):299-306. doi: 10.1016/j.joen.2005.10.050.
PubMed 16554199Friedman S, Abitbol S, Lawrence HP. Treatment outcome in endodontics: the Toronto Study. Phase 1: initial treatment. J Endod. 2003 Dec;29(12):787-93. doi: 10.1097/00004770-200312000-00001.
PubMed 14686806Farzaneh M, Abitbol S, Lawrence HP, Friedman S; Toronto Study. Treatment outcome in endodontics-the Toronto Study. Phase II: initial treatment. J Endod. 2004 May;30(5):302-9. doi: 10.1097/00004770-200405000-00002.
PubMed 15107640Moazami F, Sahebi S, Sobhnamayan F, Alipour A. Success rate of nonsurgical endodontic treatment of nonvital teeth with variable periradicular lesions. Iran Endod J. 2011 Summer;6(3):119-24. Epub 2011 Aug 15.
PubMed 23130063Paredes-Vieyra J, Enriquez FJ. Success rate of single- versus two-visit root canal treatment of teeth with apical periodontitis: a randomized controlled trial. J Endod. 2012 Sep;38(9):1164-9. doi: 10.1016/j.joen.2012.05.021. Epub 2012 Jul 26.
PubMed 22892729Ng YL, Mann V, Rahbaran S, Lewsey J, Gulabivala K. Outcome of primary root canal treatment: systematic review of the literature -- Part 2. Influence of clinical factors. Int Endod J. 2008 Jan;41(1):6-31. doi: 10.1111/j.1365-2591.2007.01323.x. Epub 2007 Oct 10.
PubMed 17931388Ng YL, Mann V, Rahbaran S, Lewsey J, Gulabivala K. Outcome of primary root canal treatment: systematic review of the literature - part 1. Effects of study characteristics on probability of success. Int Endod J. 2007 Dec;40(12):921-39. doi: 10.1111/j.1365-2591.2007.01322.x. Epub 2007 Oct 10.
PubMed 17931389Diogenes A, Ruparel NB. Regenerative Endodontic Procedures: Clinical Outcomes. Dent Clin North Am. 2017 Jan;61(1):111-125. doi: 10.1016/j.cden.2016.08.004.
PubMed 27912813Widbiller M, Eidt A, Lindner SR, Hiller KA, Schweikl H, Buchalla W, Galler KM. Dentine matrix proteins: isolation and effects on human pulp cells. Int Endod J. 2018 May;51 Suppl 4:e278-e290. doi: 10.1111/iej.12754. Epub 2017 Mar 14.
PubMed 28211068Galler KM, Buchalla W, Hiller KA, Federlin M, Eidt A, Schiefersteiner M, Schmalz G. Influence of root canal disinfectants on growth factor release from dentin. J Endod. 2015 Mar;41(3):363-8. doi: 10.1016/j.joen.2014.11.021. Epub 2015 Jan 13.
PubMed 25595468Galler KM, D'Souza RN, Federlin M, Cavender AC, Hartgerink JD, Hecker S, Schmalz G. Dentin conditioning codetermines cell fate in regenerative endodontics. J Endod. 2011 Nov;37(11):1536-41. doi: 10.1016/j.joen.2011.08.027.
PubMed 22000458Smith AJ, Scheven BA, Takahashi Y, Ferracane JL, Shelton RM, Cooper PR. Dentine as a bioactive extracellular matrix. Arch Oral Biol. 2012 Feb;57(2):109-21. doi: 10.1016/j.archoralbio.2011.07.008.
PubMed 21855856Galler KM. Clinical procedures for revitalization: current knowledge and considerations. Int Endod J. 2016 Oct;49(10):926-36. doi: 10.1111/iej.12606. Epub 2016 Feb 1.
PubMed 26715631Ducret M, Fabre H, Celle A, Mallein-Gerin F, Perrier-Groult E, Alliot-Licht B, Farges JC. Current challenges in human tooth revitalization. Biomed Mater Eng. 2017;28(s1):S159-S168. doi: 10.3233/BME-171637.
PubMed 28372291
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cell-free Autologous Regenerative Endodontics Treatment for Permanent Mature Teeth With Pulp Necrosis and Periapical Lesions: a Randomized, Controlled Phase III Clinical Trial (CARETT)
- ClinicalTrials.gov ID
- NCT05305417
- Acronym / sponsor ID
- CARETT / 211
- Conditions
- Periapical Diseases, Pulp Necroses
- Keywords
- Regenerative Endodontics, Permanent Dentition, Pulp Necroses, Periapical Diseases, Root Canal Filling Material
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 228 participants (estimated)
- Lead sponsor
- Universidad de ValparaisoUniversity, hospital or other
- Study start
- Mar 2023 (estimated)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 31 Mar 2022 (actual)
- 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.
Conventional endodontic treatment has been the treatment of choice for the management of signs and symptoms of mature permanent teeth with pulpal necrosis and periapical lesion with predictable and favorable results. However, treatment outcomes have not shown improvement or innovation in decades. The main objective of this study is to evaluate the clinical effectiveness of a regenerative endodontic procedure (cell-free and autologous protocol) versus conventional endodontics in the resolution of signs and symptoms of periapical lesion and pulp vitality-sensitivity in mature permanent teeth with a diagnosis of pulpal necrosis and periapical lesion.
Detailed description
Conventional endodontic treatment has been an effective treatment option for decades to treat signs and symptoms in mature permanent teeth with a diagnosis of apical lesion due to pulpal necrosis, allowing the teeth to be kept in the mouth free of signs/symptoms but devitalized. The clinical effectiveness of conventional treatment in this type of case is ≥80%, with some variations according to different studies. Despite advances and modifications in treatment protocols, this therapy has not shown improvements or innovations in its results in recent decades. The Regenerative Endodontics alternative is postulated as a biologically based endodontic treatment option that allows to resolve the signs and symptoms along with dental revitalization through the regeneration of the pulpal connective tissue, generating a substantive possibility of innovation and improvements to the therapy of conventional endodontics.
Various regenerative endodontic protocols have been proposed to achieve pulp tissue regeneration, from sophisticated techniques that involve cell transplantation, provision of scaffolds and/or signaling molecules, or simpler protocols that appeal to the autologous capacity of the organism to regenerate tissue. lost.
The main objective of this study is to evaluate the clinical effectiveness of a cell-free regenerative endodontic procedure with the contribution of an autologous scaffold (L-PRF) versus conventional endodontics in the recovery of signs of periapical lesion and pulp vitality-sensitivity in mature permanent teeth with diagnosis of pulpal necrosis and periapical lesion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regenerative Endodontic Treatment | Experimental | Procedure: Autologous Regenerative Endodontic TreatmentThis treatment consists of obturated the root canal preparations under an biological-based protocol using autologous biological elements and bioactive materials that allows restore the connective pulp-like tissue within the canals. |
| Conventional root canal treatment | Active comparator | Procedure: Conventional Root Canal TreatmentThis treatment consist on obturated the root canal preparations under the conventional protocol with an inert biomaterials like guttapercha and endodontics cements to seal the root canals. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male or female (18-60y) systemically healthy or chronic disease controlled
- Uniradicular or multiradicular permanent mature teeth
- Teeth with diagnosis of pulp necrosis (negative response to thermal-cold pulp test) and sings or symptoms (clinical-radiographic) of periapical lesion.
- Root anatomy with curvatures ≤ 30°
- Feasibility of adhesive tooth restoration (direct or indirect)
Key exclusion criteria (5 listed)
- Pregnant or lactating woman
- Signs of moderate or severe periodontal disease
- Teeth with signs of radicular fracture (vertical or horizontal), signs of root resorption (endo-exo)
- teeth with impossibility of good prognosis of coronary rehabilitation by direct or indirect adhesive technique
- Teeth that to treat can not to be correctly isolate with rubber dam
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 |
|---|---|---|
| Autologous Regenerative Endodontic TreatmentAlso: Pulp revascularization, Pulp revitalization, Pulp regenerationThe intervention consist in achieve an access to the teeth root canal system, do a chemico-mechanical preparation each root canal for to be obturated with an autologous biological scaffold and bioactive biomaterials to maintain teeth free of signs/symptoms caused by pulp necroses and periapical lesions | Procedure or surgery | Regenerative Endodontic Treatment |
| Conventional Root Canal TreatmentAlso: Endodontically-treated TeethThe intervention consist in achieve an access to the teeth root canal system, do a chemico-mechanical preparation each root canal for to be obturated with an inert biomaterial to maintain teeth free of signs/symptoms caused by pulp necroses and periapical lesions | Procedure or surgery | Conventional root canal treatment |
Primary outcome
Efficacy of therapy
Time frame: 12 month
Number of treated tooth that remain in mouth free of clinical (negative percussion, negative palpation, abscence of inflammation, pain and fistula) and radiographic (total or partial reduction on size of periapical lesion) signs or symptoms at 12 month post operatory.
4 secondary outcomes
Tooth re-sensibilization
Time frame: 3, 6 and 12 month
Tooth re-vitalization
Time frame: 3, 6 and 12 month
Periapical lesion resolution
Time frame: 3, 6 and 12 month
Procedure Time
Time frame: intraoperatory
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Background: PubMed 33811981Glynis A, Foschi F, Kefalou I, Koletsi D, Tzanetakis GN. Regenerative Endodontic Procedures for the Treatment of Necrotic Mature Teeth with Apical Periodontitis: A Systematic Review and Meta-analysis of Randomized Controlled Trials. J Endod. 2021 Jun;47(6):873-882. doi: 10.1016/j.joen.2021.03.015. Epub 2021 Mar 31.
- Background: PubMed 16554199Marquis VL, Dao T, Farzaneh M, Abitbol S, Friedman S. Treatment outcome in endodontics: the Toronto Study. Phase III: initial treatment. J Endod. 2006 Apr;32(4):299-306. doi: 10.1016/j.joen.2005.10.050.
- Background: PubMed 14686806Friedman S, Abitbol S, Lawrence HP. Treatment outcome in endodontics: the Toronto Study. Phase 1: initial treatment. J Endod. 2003 Dec;29(12):787-93. doi: 10.1097/00004770-200312000-00001.
- Background: PubMed 15107640Farzaneh M, Abitbol S, Lawrence HP, Friedman S; Toronto Study. Treatment outcome in endodontics-the Toronto Study. Phase II: initial treatment. J Endod. 2004 May;30(5):302-9. doi: 10.1097/00004770-200405000-00002.
- Background: PubMed 23130063Moazami F, Sahebi S, Sobhnamayan F, Alipour A. Success rate of nonsurgical endodontic treatment of nonvital teeth with variable periradicular lesions. Iran Endod J. 2011 Summer;6(3):119-24. Epub 2011 Aug 15.
- Background: PubMed 22892729Paredes-Vieyra J, Enriquez FJ. Success rate of single- versus two-visit root canal treatment of teeth with apical periodontitis: a randomized controlled trial. J Endod. 2012 Sep;38(9):1164-9. doi: 10.1016/j.joen.2012.05.021. Epub 2012 Jul 26.
- Background: PubMed 17931388Ng YL, Mann V, Rahbaran S, Lewsey J, Gulabivala K. Outcome of primary root canal treatment: systematic review of the literature -- Part 2. Influence of clinical factors. Int Endod J. 2008 Jan;41(1):6-31. doi: 10.1111/j.1365-2591.2007.01323.x. Epub 2007 Oct 10.
- Background: PubMed 17931389Ng YL, Mann V, Rahbaran S, Lewsey J, Gulabivala K. Outcome of primary root canal treatment: systematic review of the literature - part 1. Effects of study characteristics on probability of success. Int Endod J. 2007 Dec;40(12):921-39. doi: 10.1111/j.1365-2591.2007.01322.x. Epub 2007 Oct 10.
- Background: PubMed 27912813Diogenes A, Ruparel NB. Regenerative Endodontic Procedures: Clinical Outcomes. Dent Clin North Am. 2017 Jan;61(1):111-125. doi: 10.1016/j.cden.2016.08.004.
- Background: PubMed 28211068Widbiller M, Eidt A, Lindner SR, Hiller KA, Schweikl H, Buchalla W, Galler KM. Dentine matrix proteins: isolation and effects on human pulp cells. Int Endod J. 2018 May;51 Suppl 4:e278-e290. doi: 10.1111/iej.12754. Epub 2017 Mar 14.
- Background: PubMed 25595468Galler KM, Buchalla W, Hiller KA, Federlin M, Eidt A, Schiefersteiner M, Schmalz G. Influence of root canal disinfectants on growth factor release from dentin. J Endod. 2015 Mar;41(3):363-8. doi: 10.1016/j.joen.2014.11.021. Epub 2015 Jan 13.
- Background: PubMed 22000458Galler KM, D'Souza RN, Federlin M, Cavender AC, Hartgerink JD, Hecker S, Schmalz G. Dentin conditioning codetermines cell fate in regenerative endodontics. J Endod. 2011 Nov;37(11):1536-41. doi: 10.1016/j.joen.2011.08.027.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
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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.
Alicia Caro, MSC, DDS study director
Department of Endodontics, Faculty of Dentistry, University of Valparaíso, Chile.
Juan Caro, DDS principal investigator
Department of Endodontics, Faculty of Dentistry, University of Valparaíso, Chile.
Questions about this trial
What is this clinical trial studying?
A study testing Autologous Regenerative Endodontic Treatment and Conventional Root Canal Treatment in people with Periapical Diseases and Pulp Necroses, run by Universidad de Valparaiso.
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 5 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 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Juan Caro, DDS (+56975242484, juancarlos.caro@uv.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of therapy (time frame: 12 month). 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 NCT05305417, which also lists 21 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 31 Mar 2022.