Ignite Creation Date:
2024-05-06 @ 6:18 PM
Last Modification Date:
2024-10-26 @ 2:45 PM
Study NCT ID:
NCT05612451
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2022-11-10
First Post:
2022-11-02
Brief Title:
Outcome of Regenerative Endodontic Procedures
Sponsor:
King Abdullah University Hospital
Organization:
King Abdullah University Hospital
Study Overview
Official Title:
Outcome of Regenerative Endodontic Procedures for Necrotic Immature Permanent Teeth Using Two Different Protocols A Prospective Randomized Clinical Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 CaOH2 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 andor 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 CaOH2 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 CaOH2 n25 or modified triple antibiotic paste TAP n25 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None