Clinical trial NCT03083015: Pulp Revascularization Versus MTA Apexification
Official title: A Comparative Study Between Pulp Revascularization and MTA Apexification in Necrotic Immature Anterior Teeth, A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Necrotic Pulp
Keywords: regeneration, MTA apexification and TAP
revascularization
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-03-17
Enrollment: 66
Sex: ALL
Minimum age (years): 7
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: participants are allocated at random to receive one of two interventions according to the research plan. In RCT the outcomes are measured, so it is considered a quantitative study . This trial conforms to the Consolidated Standard of Reporting Trials (CONSORT)statement.
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pain intensity measures
timeFrame: 2 days
Secondary outcomes:
measure: Resolution of periapical pathosis
timeFrame: 9 months
measure: Amount of radiographic increase in root length:
timeFrame: baseline and 9 months
measure: Amount of radiographic increase in the root dentinal wall thickness:
timeFrame: baseline and 9 months
measure: Decrease of apical diameter:
timeFrame: baseline and 9 months
Other outcomes:
Locations:
Study officials:
affiliation: evidence based center, Cairo University
name: ahmed alkhadem, lecturer
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.