Endodontic DiseaseNCT05612451
Outcome of Regenerative Endodontic Procedures
A study testing Regenerative Endodontic Procedures, non-setting calcium hydroxide and modified triple antibiotic paste in people with Endodontic Disease, run by King Abdullah University Hospital at 1 site in Jordan.
Trial summary
Clinical management of immature non-vital (necrotic) permanent teeth is challenging, due to inherent structural weakness. Earlier management of such teeth relied on the traditional calcium hydroxide (Ca(OH)2) apexification procedure or the application of apical barriers However, neither procedure allows for promoting… Read more about this study
- Who is it for?
- Ages 7 to 19 years
- Conditions the study is for
- Endodontic Disease
- What is being tested?
- Regenerative Endodontic Procedures, non-setting calcium hydroxide and modified triple antibiotic paste
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteJordan
- Study dates
- 20 Mar 2018to 27 Jun 2024
- 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 7 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Anterior or posterior tooth diagnosed with necrotic pulp (as a result of trauma, caries or anomaly) in the presence or absence of apical periodontitis.
- an immature apex or open apex(an apical diameter wider than 1 mm and is radiographically visible)
- Pulp space not needed for post and core restoration
- A cooperative and Compliant patient/ parent
- Patients not allergic to medicaments necessary to complete the procedure.
Who cannot join
- medically compromised patient,
- teeth with vertical fractures,
- periodontally involved teeth,
- non-restorable teeth,
- teeth when bleeding could not be induced.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Outcome of Regenerative Endodontic Procedures for Necrotic Immature Permanent Teeth, Using Two Different Protocols: A Prospective Randomized Clinical Study.
Clinical management of immature non-vital (necrotic) permanent teeth is challenging, due to inherent structural weakness. Earlier management of such teeth relied on the traditional calcium hydroxide (Ca(OH)2) apexification procedure or the application of apical barriers However, neither procedure allows for promoting root dentin maturation. In 2004, a novel management technique for treating immature, non-vital teeth called regenerative endodontic procedures (REP; also known as revascularization) was introduced. This procedure allowed for continued root maturation presented in an increase in root length and dentin wall thickness. The key points of REP include minimal or no instrumentation of the dentinal walls, disinfection with irrigant solutions and intracanal medicaments, provocation of bleeding into the canal space for creation of a blood clot, capping with calcium silicate-based material, and an effective coronal seal to prevent reinfection of the root canal system. Several case reports and clinical studies reported promising results for REP treatment. However, studies widely varied in their treatment methods, hence the search for an optimal REP protocol is still ongoing. A recent review reported that the methodological quality of REP clinical trials available to date, was low with a moderate to high risk of bias. To date, only few studies evaluated the outcome of REPs based on different types of intracanal medicaments. These studies either presented a retrospective design, low sample size and/or short follow up period. Hence, the need for randomized, controlled clinical studies to provide persuasive evidence on the efficacy of different intracanal medicaments in REP is of utmost importance. The aim of this study is to prospectively assess and compare the clinical and radiographic outcomes of REP in non-vital immature permanent teeth using an intracanal medicament modified TAP or non-setting Ca(OH)2 paste. Forty-five patients yielding a total of 50 anterior and posterior non-vital immature teeth were randomly divided into 2 groups. REP utilizing either non-setting calcium hydroxide (Ca(OH)2) (n=25) or modified triple antibiotic paste (TAP) (n=25), as intracanal medicaments were performed. NeoMTA Plus was applied for coronal sealing. Cases were followed up clinically and radiographically for 24 months. Survival rate, success rate, and clinical outcome measures were analyzed.
- Conditions
- Endodontic Disease
- Being tested
- Regenerative Endodontic Procedures, non-setting calcium hydroxide, modified triple antibiotic paste
- Keywords
- Endodontic regeneration, Immature teeth, Randomized controlled trial
- Medical subject headings
- Dental Pulp Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regenerative Endodontic ProceduresProcedure or surgery
Regenerative Endodontic procedures were performed by one operator following similar protocols according to the clinical considerations for a regenerative procedure advised by the American Association of Endodontists and European Society of Endodontology
non-setting calcium hydroxideOther
non-setting calcium hydroxide
modified triple antibiotic pasteOther
modified triple antibiotic paste
| Study group | Role | What they receive |
|---|---|---|
| non-setting calcium hydroxide | Experimental | Regenerative Endodontic Procedure utilizing non-setting calcium hydroxide as intracanal medicament Receives: Procedure: Regenerative Endodontic Procedures; Other: non-setting calcium hydroxide |
| modified triple antibiotic paste | Experimental | Regenerative Endodontic Procedure utilizing modified triple antibiotic paste as intracanal medicament Receives: Procedure: Regenerative Endodontic Procedures; Other: modified triple antibiotic paste |
What is being measured
The primary outcome is the main question the study is designed to answer.
treatment success
disappearance of clinical signs and symptoms including tenderness to percussion or palpation, a swelling or sinus tract, or spontaneous pain, and absence or reduction in the size of periapiacl radiolucency
Measured: 36 months
Secondary outcomes (3)
root elongation
increased root length
Measured: 36 months
root maturation
increased root dentin thickness
Measured: 36 months
root completion
apical closure
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2022
- Study start20 Mar 2018
- Primary completion30 Jun 2021
- Study completion27 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Endodontic DiseaseStudies 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
- This randomized clinical trial aimed to assess and compare the clinical and radiographic outcomes of Regenerative Endodontic Procedures (REP) in treating non-vital immature permanent teeth using two intracanal medicaments.
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Abdullah University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aladdin A Al-Qudah, PhD, Principal investigator, Jordan University of Science & Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05612451
- Sponsor's protocol ID
- 20180112
- Status last verified
- Nov 2022
- First submitted
- 2 Nov 2022
- Last updated
- 10 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication will be shared
Publications
Duggal M, Tong HJ, Al-Ansary M, Twati W, Day PF, Nazzal H. Interventions for the endodontic management of non-vital traumatised immature permanent anterior teeth in children and adolescents: a systematic review of the evidence and guidelines of the European Academy of Paediatric Dentistry. Eur Arch Paediatr Dent. 2017 Jun;18(3):139-151. doi: 10.1007/s40368-017-0289-5. Epub 2017 May 15.
PubMed 28508244Saoud TM, Zaazou A, Nabil A, Moussa S, Lin LM, Gibbs JL. Clinical and radiographic outcomes of traumatized immature permanent necrotic teeth after revascularization/revitalization therapy. J Endod. 2014 Dec;40(12):1946-52. doi: 10.1016/j.joen.2014.08.023. Epub 2014 Oct 16.
PubMed 25443280European Society of Endodontology (ESE) developed by:; Krastl G, Weiger R, Filippi A, Van Waes H, Ebeleseder K, Ree M, Connert T, Widbiller M, Tjaderhane L, Dummer PMH, Galler K. European Society of Endodontology position statement: endodontic management of traumatized permanent teeth. Int Endod J. 2021 Sep;54(9):1473-1481. doi: 10.1111/iej.13543. Epub 2021 Jun 20.
PubMed 33934366Sponchiado-Junior EC, Vieira WA, Frozoni M, Herkrath FJ, de-Jesus-Soares A. CONSORT Compliance in Randomized Clinical Trials of Regenerative Endodontic Treatments of Necrotic Immature Teeth: A Scoping Review. J Endod. 2021 Nov;47(11):1751-1766. doi: 10.1016/j.joen.2021.07.017. Epub 2021 Aug 3.
PubMed 34352304Chan EK, Desmeules M, Cielecki M, Dabbagh B, Ferraz Dos Santos B. Longitudinal Cohort Study of Regenerative Endodontic Treatment for Immature Necrotic Permanent Teeth. J Endod. 2017 Mar;43(3):395-400. doi: 10.1016/j.joen.2016.10.035. Epub 2017 Jan 19.
PubMed 28110920ElSheshtawy AS, Nazzal H, El Shahawy OI, El Baz AA, Ismail SM, Kang J, Ezzat KM. The effect of platelet-rich plasma as a scaffold in regeneration/revitalization endodontics of immature permanent teeth assessed using 2-dimensional radiographs and cone beam computed tomography: a randomized controlled trial. Int Endod J. 2020 Jul;53(7):905-921. doi: 10.1111/iej.13303. Epub 2020 Apr 30.
PubMed 32249441
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of Regenerative Endodontic Procedures for Necrotic Immature Permanent Teeth, Using Two Different Protocols: A Prospective Randomized Clinical Study.
- ClinicalTrials.gov ID
- NCT05612451
- Acronym / sponsor ID
- 20180112
- Conditions
- Endodontic Disease
- Keywords
- Endodontic regeneration, Immature teeth, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (actual)
- Lead sponsor
- King Abdullah University HospitalUniversity, hospital or other
- Study start
- 20 Mar 2018 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 27 Jun 2024 (estimated)
- First posted
- 10 Nov 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.
Clinical management of immature non-vital (necrotic) permanent teeth is challenging, due to inherent structural weakness. Earlier management of such teeth relied on the traditional calcium hydroxide (Ca(OH)2) apexification procedure or the application of apical barriers However, neither procedure allows for promoting root dentin maturation. In 2004, a novel management technique for treating immature, non-vital teeth called regenerative endodontic procedures (REP; also known as revascularization) was introduced. This procedure allowed for continued root maturation presented in an increase in root length and dentin wall thickness. The key points of REP include minimal or no instrumentation of the dentinal walls, disinfection with irrigant solutions and intracanal medicaments, provocation of bleeding into the canal space for creation of a blood clot, capping with calcium silicate-based material, and an effective coronal seal to prevent reinfection of the root canal system. Several case reports and clinical studies reported promising results for REP treatment. However, studies widely varied in their treatment methods, hence the search for an optimal REP protocol is still ongoing. A recent review reported that the methodological quality of REP clinical trials available to date, was low with a moderate to high risk of bias. To date, only few studies evaluated the outcome of REPs based on different types of intracanal medicaments. These studies either presented a retrospective design, low sample size and/or short follow up period. Hence, the need for randomized, controlled clinical studies to provide persuasive evidence on the efficacy of different intracanal medicaments in REP is of utmost importance. The aim of this study is to prospectively assess and compare the clinical and radiographic outcomes of REP in non-vital immature permanent teeth using an intracanal medicament modified TAP or non-setting Ca(OH)2 paste. Forty-five patients yielding a total of 50 anterior and posterior non-vital immature teeth were randomly divided into 2 groups. REP utilizing either non-setting calcium hydroxide (Ca(OH)2) (n=25) or modified triple antibiotic paste (TAP) (n=25), as intracanal medicaments were performed. NeoMTA Plus was applied for coronal sealing. Cases were followed up clinically and radiographically for 24 months. Survival rate, success rate, and clinical outcome measures were analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This randomized clinical trial aimed to assess and compare the clinical and radiographic outcomes of Regenerative Endodontic Procedures (REP) in treating non-vital immature permanent teeth using two intracanal medicaments.
| Arm | Type | Receives |
|---|---|---|
| non-setting calcium hydroxide | Experimental | Procedure: Regenerative Endodontic Procedures, Other: non-setting calcium hydroxideRegenerative Endodontic Procedure utilizing non-setting calcium hydroxide as intracanal medicament |
| modified triple antibiotic paste | Experimental | Procedure: Regenerative Endodontic Procedures, Other: modified triple antibiotic pasteRegenerative Endodontic Procedure utilizing modified triple antibiotic paste as intracanal medicament |
Who may qualify
- Ages
- 7 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Anterior or posterior tooth diagnosed with necrotic pulp (as a result of trauma, caries or anomaly) in the presence or absence of apical periodontitis.
- an immature apex or open apex(an apical diameter wider than 1 mm and is radiographically visible)
- Pulp space not needed for post and core restoration
- A cooperative and Compliant patient/ parent
- Patients not allergic to medicaments necessary to complete the procedure.
Key exclusion criteria (5 listed)
- medically compromised patient,
- teeth with vertical fractures,
- periodontally involved teeth,
- non-restorable teeth,
- teeth when bleeding could not be induced.
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 ProceduresRegenerative Endodontic procedures were performed by one operator following similar protocols according to the clinical considerations for a regenerative procedure advised by the American Association of Endodontists and European Society of Endodontology | Procedure or surgery | modified triple antibiotic paste, non-setting calcium hydroxide |
| non-setting calcium hydroxidenon-setting calcium hydroxide | Other | non-setting calcium hydroxide |
| modified triple antibiotic pastemodified triple antibiotic paste | Other | modified triple antibiotic paste |
Primary outcome
treatment success
Time frame: 36 months
disappearance of clinical signs and symptoms including tenderness to percussion or palpation, a swelling or sinus tract, or spontaneous pain, and absence or reduction in the size of periapiacl radiolucency
3 secondary outcomes
root elongation
Time frame: 36 months
root maturation
Time frame: 36 months
root completion
Time frame: 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2022.
- Results publication: PubMed 28508244Duggal M, Tong HJ, Al-Ansary M, Twati W, Day PF, Nazzal H. Interventions for the endodontic management of non-vital traumatised immature permanent anterior teeth in children and adolescents: a systematic review of the evidence and guidelines of the European Academy of Paediatric Dentistry. Eur Arch Paediatr Dent. 2017 Jun;18(3):139-151. doi: 10.1007/s40368-017-0289-5. Epub 2017 May 15.
- Results publication: PubMed 25443280Saoud TM, Zaazou A, Nabil A, Moussa S, Lin LM, Gibbs JL. Clinical and radiographic outcomes of traumatized immature permanent necrotic teeth after revascularization/revitalization therapy. J Endod. 2014 Dec;40(12):1946-52. doi: 10.1016/j.joen.2014.08.023. Epub 2014 Oct 16.
- Results publication: PubMed 33934366European Society of Endodontology (ESE) developed by:; Krastl G, Weiger R, Filippi A, Van Waes H, Ebeleseder K, Ree M, Connert T, Widbiller M, Tjaderhane L, Dummer PMH, Galler K. European Society of Endodontology position statement: endodontic management of traumatized permanent teeth. Int Endod J. 2021 Sep;54(9):1473-1481. doi: 10.1111/iej.13543. Epub 2021 Jun 20.
- Results publication: PubMed 34352304Sponchiado-Junior EC, Vieira WA, Frozoni M, Herkrath FJ, de-Jesus-Soares A. CONSORT Compliance in Randomized Clinical Trials of Regenerative Endodontic Treatments of Necrotic Immature Teeth: A Scoping Review. J Endod. 2021 Nov;47(11):1751-1766. doi: 10.1016/j.joen.2021.07.017. Epub 2021 Aug 3.
- Results publication: PubMed 28110920Chan EK, Desmeules M, Cielecki M, Dabbagh B, Ferraz Dos Santos B. Longitudinal Cohort Study of Regenerative Endodontic Treatment for Immature Necrotic Permanent Teeth. J Endod. 2017 Mar;43(3):395-400. doi: 10.1016/j.joen.2016.10.035. Epub 2017 Jan 19.
- Results publication: PubMed 32249441ElSheshtawy AS, Nazzal H, El Shahawy OI, El Baz AA, Ismail SM, Kang J, Ezzat KM. The effect of platelet-rich plasma as a scaffold in regeneration/revitalization endodontics of immature permanent teeth assessed using 2-dimensional radiographs and cone beam computed tomography: a randomized controlled trial. Int Endod J. 2020 Jul;53(7):905-921. doi: 10.1111/iej.13303. Epub 2020 Apr 30.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication will be shared
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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.
Aladdin A Al-Qudah, PhD principal investigator
Jordan University of Science & Technology
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 Procedures, non-setting calcium hydroxide and modified triple antibiotic paste in people with Endodontic Disease, run by King Abdullah University Hospital at 1 site in Jordan.
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 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 10 Nov 2022. 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 Jordan. 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?
Results are not available in the source record.
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?
treatment success (time frame: 36 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 NCT05612451, which also lists 6 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 10 Nov 2022.