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

Pulp Necrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03849222
• Other study ID #: REC 61
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: August 20, 2013
• Est. completion date: September 1, 2016

Study information

• Verified date: February 2019
• Source: Al-Azhar University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: September 1, 2016
• Est. primary completion date: April 20, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Apexification
• Dental Pulp Necrosis
• Necrosis
• Pulp Necrosis

Intervention

Procedure:
• Apexification

Drug:
• MTA

• Ca(OH)2

• Apical matrix
collagen membrane (Biocollagen; Bioteck:Turin, Italy)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Al-Azhar University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in pain on percussion	Assessed by tapping the tooth with the back of the mirror (Present or absent) binary outcome	baseline, 3 months, 6 months, and 12 months
Primary	Change in swelling and/or sinus	Assessed by visual examination of labial vestibule.The presence of swelling or sinus reported by a binary question yes/no	baseline, 3 months, 6 months, and 12 months
Primary	Change in periapical pathosis	Change in periapical bone density on follow up radiographs to assess the healing process	12 months
Secondary	presence of a calcified apical barrier or not	Teeth will be reviewed clinically and radiographically in order to detect the calcific barrier formation	3, 6 and 12 months
Secondary	Periapical Lesion scored with periapical index ( PAI)	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-de?ned radiolucent area. (5) Severe periodontitis with exacerbating features. (1, 2: healthy and 3, 4, 5: pathological).baseline, 3 months, 6 months, and 12 months	12 months