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Evaluation the Effect of Using of Apical Matrix With Apexification Procedure on Apical Healing of Necrotic Immature Teeth

Enhancement of Apexification Procedure Outcome of Non Vital Incompletely Formed Roots Using Apical Matrix

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03849222
Enrollment
32
Registered
2019-02-21
Start date
2013-08-20
Completion date
2016-09-01
Last updated
2019-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Apexification, Pulp Necrosis

Keywords

Open apex, Immature teeth, Non vital pulp, Apical plug, Internal matrix

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.

Interventions

PROCEDUREApexification
DRUGMTA
DRUGCa(OH)2
DRUGApical matrix

collagen membrane (Biocollagen; Bioteck:Turin, Italy)

Sponsors

Al-Azhar University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Intervention model description

participants are allocated at random to receive one of 4 interventions according to the research plan.

Eligibility

Sex/Gender
ALL
Age
8 Years to 16 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in pain on percussionbaseline, 3 months, 6 months, and 12 monthsAssessed by tapping the tooth with the back of the mirror (Present or absent) binary outcome
Change in swelling and/or sinusbaseline, 3 months, 6 months, and 12 monthsAssessed by visual examination of labial vestibule.The presence of swelling or sinus reported by a binary question yes/no
Change in periapical pathosis12 monthsChange in periapical bone density on follow up radiographs to assess the healing process

Secondary

MeasureTime frameDescription
presence of a calcified apical barrier or not3, 6 and 12 monthsTeeth will be reviewed clinically and radiographically in order to detect the calcific barrier formation
Periapical Lesion scored with periapical index ( PAI)12 monthsRadio graphically The periapical index provides an ordinal scale of 5 scores ranging from ''healthy'' to ''severe periodontitis with exacerbating features''. (1) Normal periapical structures. (2) Small changes in bone structure. (3) Changes in bone structure with some diffuse mineral loss.(4) Periodontitis with well-defined radiolucent area. (5) Severe periodontitis with exacerbating features. (1, 2: healthy and 3, 4, 5: pathological).baseline, 3 months, 6 months, and 12 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026