The Present Study Was Conducted to Evaluate Bioceramic Root Repair Material Versus Bio MTA in Revascularization of Immature Young Permenant Teeth.

NCT06630156 | Active Not Recruiting Phase 2

• 1 other identifier: Treatment of immature teeth
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

The present clinical study wasdirected to evaluate bioceramic root repair material versus Bio MTA in Revascularization of Immature Young Permenant Teeth through:

1. 1.Clinical evaluation including: Pain, swelling, sinus or fistula, mobility and crown discoloration.
2. 2.Radiographic evaluation including: Root lengthening, continued thickening of the dentinal walls, apical closure and regression of the peri-apical lesion.

Conditions

Revascularization of Immature Young Permenant Teeth

Keywords

Revascularization; Bio MTA; Total Fill biocearmic root repair material

Outcome Measures

Primary Outcomes (1)

• radiographic parameters

  continued root lengthening and thickening of the dentinal walls in mm

  baseline, 3, 6, and 12 months after treatment

Study Arms (2)

Bio-MTA revascularization

ACTIVE COMPARATOR

Biological: Revascularization of Immature Young Permenant Teeth

Total Fill biocearmic root repair material revascularization

ACTIVE COMPARATOR

Biological: Revascularization of Immature Young Permenant Teeth

Interventions

Revascularization of Immature Young Permenant Teeth BIOLOGICAL

An access cavity was prepared under rubber dam, isolation, root canal system disinfection was done without mechanical instrumentation. Subsequently, triple antibiotic paste was placed into the apical portion of the canal and filled to just below the CEJ. The access cavity was temporarily restored with glass ionomer. 4 weeks later, after reopening of the access, the antibiotic paste was gently flushed out of the canal with sterile normal saline. The root canal system was irrigated. A sterile #35 K-file will be introduced into the canal beyond the apical foramen using a push and pull motion to provoke bleeding from the periapical tissue. After bleeding control and formation of fresh blood clot, 3 mm of Bio (MTA) will be placed in Group A, 3 mm of Total Fill biocearmic root repair material will be placed in Group B after a moist cotton pellet was placed over the capping material and the access cavity will be sealed with G C

Bio-MTA revascularization; Total Fill biocearmic root repair material revascularization

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Child with an age ranged from (7-12) year from both sexes.
• Patient and parent cooperation.
• Non vital immature permanent teeth indicated for endodontic treatment as a result of pulp necrosis.
• Patient is not taking antibiotic and has not taken for the past 2 weeks.
• Restorable teeth.
• The root to crown ratio should be at least 1:1.

You may not qualify if:

• Patients allergic to any drug used in this RCT.
• Patients with any systemic disease that would contraindicate pulp therapy (rheumatic fever, infective endocarditis, leukemia, corticosteroid therapy and immune suppressed children).
• Tooth with vital pulp or complete root formation.
• Teeth with draining sinus or periodontal weak mobile teeth.
• Teeth with internal or external root resorption.
• Tooth with root fracture.

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

faculty of dental medicine, Al-Azhar university

Asyut, Egypt

Location

Related Publications (11)

• Murray PE, Garcia-Godoy F, Hargreaves KM. Regenerative endodontics: a review of current status and a call for action. J Endod. 2007 Apr;33(4):377-90. doi: 10.1016/j.joen.2006.09.013. Epub 2007 Feb 20.

  PMID: 17368324 BACKGROUND

• Kim DS, Park HJ, Yeom JH, Seo JS, Ryu GJ, Park KH, Shin SI, Kim SY. Long-term follow-ups of revascularized immature necrotic teeth: three case reports. Int J Oral Sci. 2012 Jun;4(2):109-13. doi: 10.1038/ijos.2012.23.

  PMID: 22627612 BACKGROUND

• Bose R, Nummikoski P, Hargreaves K. A retrospective evaluation of radiographic outcomes in immature teeth with necrotic root canal systems treated with regenerative endodontic procedures. J Endod. 2009 Oct;35(10):1343-9. doi: 10.1016/j.joen.2009.06.021. Epub 2009 Aug 15.

  PMID: 19801227 BACKGROUND

• Shuping GB, Orstavik D, Sigurdsson A, Trope M. Reduction of intracanal bacteria using nickel-titanium rotary instrumentation and various medications. J Endod. 2000 Dec;26(12):751-5. doi: 10.1097/00004770-200012000-00022.

  PMID: 11471648 BACKGROUND

• Chen MY, Chen KL, Chen CA, Tayebaty F, Rosenberg PA, Lin LM. Responses of immature permanent teeth with infected necrotic pulp tissue and apical periodontitis/abscess to revascularization procedures. Int Endod J. 2012 Mar;45(3):294-305. doi: 10.1111/j.1365-2591.2011.01978.x. Epub 2011 Nov 14.

  PMID: 22077958 BACKGROUND

• Asgary S, Fazlyab M, Nosrat A. Regenerative Endodontic Treatment versus Apical Plug in Immature Teeth: Three-Year Follow-Up. J Clin Pediatr Dent. 2016;40(5):356-60. doi: 10.17796/1053-4628-40.5.356.

  PMID: 27617375 BACKGROUND

• Chuensombat S, Khemaleelakul S, Chattipakorn S, Srisuwan T. Cytotoxic effects and antibacterial efficacy of a 3-antibiotic combination: an in vitro study. J Endod. 2013 Jun;39(6):813-9. doi: 10.1016/j.joen.2012.11.041. Epub 2013 Jan 27.

  PMID: 23683284 BACKGROUND

• Banchs F, Trope M. Revascularization of immature permanent teeth with apical periodontitis: new treatment protocol? J Endod. 2004 Apr;30(4):196-200. doi: 10.1097/00004770-200404000-00003.

  PMID: 15085044 BACKGROUND

• Jitaru S, Hodisan I, Timis L, Lucian A, Bud M. The use of bioceramics in endodontics - literature review. Clujul Med. 2016;89(4):470-473. doi: 10.15386/cjmed-612. Epub 2016 Oct 20.

  PMID: 27857514 BACKGROUND

• Alobaid AS, Cortes LM, Lo J, Nguyen TT, Albert J, Abu-Melha AS, Lin LM, Gibbs JL. Radiographic and clinical outcomes of the treatment of immature permanent teeth by revascularization or apexification: a pilot retrospective cohort study. J Endod. 2014 Aug;40(8):1063-70. doi: 10.1016/j.joen.2014.02.016. Epub 2014 Jun 13.

  PMID: 25069909 BACKGROUND

• Torabinejad M, Pitt Ford TR. Root end filling materials: a review. Endod Dent Traumatol. 1996 Aug;12(4):161-78. doi: 10.1111/j.1600-9657.1996.tb00510.x.

  PMID: 9028180 BACKGROUND

Study Officials

• Reda Mohammed Elsayed, assistant lecturer

  Faculty of Dental Medicine, Al- Azhar University, Assuit, Egypt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The statistician and the assessor were blinded, but the operator was not because of the nature of the study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer

Model Details: The patients selected in this study were randomly divided into 2 groups: 1. Group A: 14 teeth were disinfected by triple paste and treated by Bio-MTA. 2. Group A: 14 teeth were disinfected by triple paste and treated by a Total Fill biocearmic root repair.

Study Record Dates

• First Submitted: October 4, 2024
• First Posted: October 8, 2024
• Study Start: August 21, 2022
• Primary Completion: November 21, 2024
• Study Completion: December 21, 2024
• Last Updated: October 15, 2024

Record last verified: 2024-10

Locations

EG (1)