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Completed

NCT Number: NCT03849222

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

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.

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Key information

Age range

8 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Apexification

Procedure

MTA

Drug

Other names: Proroot MTA

Ca(OH)2

Drug

Other names: Ca(OH)2 dressing

Apical matrix

Drug

collagen membrane (Biocollagen; Bioteck:Turin, Italy)

Other names: internal matrix

Primary outcomes

  1. Change in pain on percussion

    Time frame: baseline, 3 months, 6 months, and 12 months

    Assessed by tapping the tooth with the back of the mirror (Present or absent) binary outcome

  2. Change in swelling and/or sinus

    Time frame: baseline, 3 months, 6 months, and 12 months

    Assessed by visual examination of labial vestibule.The presence of swelling or sinus reported by a binary question yes/no

  3. Change in periapical pathosis

    Time frame: 12 months

    Change in periapical bone density on follow up radiographs to assess the healing process

Secondary outcomes

  1. presence of a calcified apical barrier or not

    Time frame: 3, 6 and 12 months

    Teeth will be reviewed clinically and radiographically in order to detect the calcific barrier formation

  2. Periapical Lesion scored with periapical index ( PAI)

    Time frame: 12 months

    Radio 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

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Feb 21, 2019
Registry last updated
Feb 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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