Clinical trial NCT03849222: Evaluation the Effect of Using of Apical Matrix With Apexification Procedure on Apical Healing of Necrotic Immature Teeth
Official title: Enhancement of Apexification Procedure Outcome of Non Vital Incompletely Formed Roots Using Apical Matrix
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Pulp Necrosis
Apexification
Keywords: Open apex
Immature teeth
Non vital pulp
Apical plug
Internal matrix
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2019-02-21
Enrollment: 32
Sex: ALL
Minimum age (years): 8
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 4 interventions according to the research plan.
Primary purpose: TREATMENT

Brief summary: This study was conducted to evaluate the effect of the use of apical matrix, with Mineral Trioxide Aggregate (MTA) or calcium hydroxide Ca(OH)2 Apexification on apical healing and calcific barrier formation of immature teeth with non- vital pulp.

Detailed description: Conventional root canal ﬁlling procedures are challenging in cases of teeth with necrotic pulp, immature apices, and periapical lesions because of the absence of natural apical constriction and the presence of moisture contamination. In these cases, the risk of extrusion of the root ﬁlling materials and the difﬁculty in managing apical seals compromise the long-term outcome of treatment.

Management of immature teeth with non-vital pulp were confined to custom fitting the filling material, paste fills and apical surgery. The limited success enjoyed by these procedures resulted in significant interest in the phenomenon of establishment of an apical barrier like apexification or continued apical development. Apexification defined as a procedure to induce a calcified barrier in a root with an open apex and necrotic pulp Traditionally, the most commonly used material for apexification is Ca(OH)2 .Despite the high success rate of The long-term Ca(OH)2 apexification , there are several disadvantages to this technique; Length of time for induction of apical hard tissue barriers. Incomplete apical hard tissue barriers because of vascular inclusions.To avoid the challenges associated with long-term Ca(OH)2 apexification procedures, a non-surgical, one-step apexification using MTA as apical plug.

The major problem in cases of a wide open apex is the need to limit the apexification material at the apex, thus avoiding the extrusion of a large amount of material into the periodontal tissue. The use of a matrix is advisable since its placement in the area of bone destruction provides a base on which the sealing material can be packed .

This randomized controlled trial study was carried out to compare the clinical and radiographic outcome of Ca(OH)2 and MTA with or without internal matrix in non-vital immature maxillary incisors.

Eligibility criteria: Inclusion Criteria:

* Immature permanent maxillary anterior teeth
* Non vital pulp
* 6-18 years old
* Half or more root length developed Restorable
* No internal or external root resorption
* No horizontal or vertical root fractures
* Fit and healthy patient

Exclusion Criteria:

* Mature
* Vital pulp
* \<6 ,\>18 years old
* Less than half of the root developed
* Non - restorable
* Root resorption
* Horizontal or vertical root fractures
* Patients with history of uncontrolled diabetes, immunosuppression, severe asthma Patients suffering from periodontal disease

Primary outcomes:
measure: Change in pain on percussion
timeFrame: baseline, 3 months, 6 months, and 12 months
measure: Change in swelling and/or sinus
timeFrame: baseline, 3 months, 6 months, and 12 months
measure: Change in periapical pathosis
timeFrame: 12 months
Secondary outcomes:
measure: presence of a calcified apical barrier or not
timeFrame: 3, 6 and 12 months
measure: Periapical Lesion scored with periapical index ( PAI)
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Professor of Endodontics AL-Azhar university
name: Mervat IB Fawzy, Professor
role: STUDY_DIRECTOR
References: