Pulp Revascularization Versus MTA Apexification

NCT03083015 — Not applicable, Completed, 66 participants, Enas Ebrahim Sayed

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A Comparative Study Between Pulp Revascularization and MTA Apexification in Necrotic Immature Anterior Teeth, A Randomized Controlled Trial

RegistryNCT03083015, acronym RCT
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: triple, treatment
Enrollment66 (Actual)
SponsorEnas Ebrahim Sayed (Other)
ConditionsNecrotic Pulp
Interventionsrevascularization, Apexification (Procedure)
Datesstart 2012-12-06, primary completion 2015-12-02, completion 2015-12-02, first posted 2017-03-17, last updated 2017-03-21

Related Papers Related Patents Related Grants Related Experts
All trials for Necrotic Pulp All trials of revascularization All trials of Apexification

-Summary

This study compared the efficiency of pulp revascularization and MTA apexification in the treatment of patients with necrotic immature anterior teeth.

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+Detailed description

the participants with 66 anterior necrotic immature teeth were randomly assigned into two equal groups with 33 teeth per each, according to regeneration and MTA apexification. At the first visit, all teeth were accessed and irrigated with NaOCl then a TAP was applied as intra-appointment intracanal medication. At the second visit, after removal of the medication with the irrigation, bleeding was initiated into the canal and isolated by the MTA in the orifice in the regeneration group. While in the Apexification group, the MTA was packed apically and all teeth were finally restored with resin composite restorations. The patients were recalled after 1, 3, 6, and 9 months for clinical and radiographic follow up.

+Arms and interventions

ArmTypeInterventionsDescription
RevascularizationExperimentalProcedure: revascularizationBlood clot initiation and grey MTA ( Mineral Tri-oxide Aggregate) cervically compacted.
ApexficationActive comparatorProcedure: ApexificationApexification using grey MTA apically compacted without mechanical preparation.
  • revascularization (Procedure), also known as regeneration: a sterile sharp needle was used to irritate the apical tissue until bleeding occurred apically in the root canal space so as to create a biological scaffold for the regenerative process
  • Apexification (Procedure): a 3-5 mm thickness of MTA using a hand plugger and was verified radiographically.

+Outcome measures

Primary outcomes

  • Pain intensity measures [2 days]: self reported pain intesity at 4, 12, 24, and 48 hours.(0= no pain and 100=worst pain) with a scale from 0 to 100 after the two visits.

Secondary outcomes

  • Resolution of periapical pathosis [9 months]: Radiographically: by comparing radiolucencies in 9 months postoperative radiograph to the baseline radiograph.
  • Amount of radiographic increase in root length: [baseline and 9 months]: Root length was measured as a straight line from the cement-enamel junction to the radiographic apex of the tooth in millimeters = (9months follow up length - baseline length)
  • Amount of radiographic increase in the root dentinal wall thickness: [baseline and 9 months]: Dentin thickness was measured by =root thickness-pulp space and compared to the baseline radiograph measurements.
  • Decrease of apical diameter: [baseline and 9 months]: the diameter of the apical foramen was measured in millimeters and compared to the baseline radiograph measurements

+Eligibility

Sex: All, ages: 7 Years to 16 Years, accepts healthy volunteers

Inclusion Criteria:

* Medically-free patients having immature necrotic anterior teeth (with or without apical periodontitis/abscess) even with previous intervention.

Exclusion Criteria:

* History of allergy to any of the antibiotics in the tri-mix used in the study
* Patients with systemic diseases e.g. Diabetes mellitus, bleeding disorders,…
* Psychological disturbance
* External / internal root resorption or cystic lesion.

+Publications

  • Results publication: Saoud 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. PMID 25443280
  • Results publication: 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

+Investigators

  • ahmed alkhadem, lecturer, Principal investigator, evidence based center, Cairo University