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

NCT ID: NCT03849222

Last Updated: 2019-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-20
• Study Completion Date: 2016-09-01

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.

Conditions

Pulp Necrosis; Apexification

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Ca(OH)2 Apexification

Apexification was performed with calcium hydroxide. calcium hydroxide dressing was applied directly against the open apex .The canals were back filled with Ca(OH)2 dressing, followed by proper coronal seal. Patients were recalled every 3, 6 and 12 months for evaluation clinically and radiographically. Once the calcific apical barrier was detected the root canals were then obturated and final restoration was done.

Group Type: ACTIVE_COMPARATOR

Apexification

Intervention Type: PROCEDURE

Ca(OH)2

Intervention Type: DRUG

Ca(OH)2 Apexification with apical matrix

Treated by condensation of calcium hydroxide dressing against an internal matrix , a piece (4X4mm) of resorbable collagen membrane (Biocollagen; Bioteck:Turin, Italy) was gently compacted toward the apex before insertion of Ca(OH)2 dressing, followed by proper coronal seal. Patients were recalled every 3, 6 and 12 months for evaluation clinically and radiographically. Once the calcific apical barrier was detected the root canals were then obturated and final restoration was done.

Group Type: EXPERIMENTAL

Apexification

Intervention Type: PROCEDURE

Ca(OH)2

Intervention Type: DRUG

Apical matrix

Intervention Type: DRUG

collagen membrane (Biocollagen; Bioteck:Turin, Italy)

MTA Apexification

Apexification was performed with MTA as apical plug. A 3-5 mm thickness of MTA using a hand plugger was applied as apical plug and verified radiographically. Moist cotton pellet was placed over the MTA followed by application of coronal seal. After 48 h, the set of the MTA was checked and final obturation of the root canal was done

Group Type: ACTIVE_COMPARATOR

Apexification

Intervention Type: PROCEDURE

MTA

Intervention Type: DRUG

MTA Apexification with apical matrix

An internal (apical) matrix was used as a base for condensation of MTA apical plug, a pieces of (4X4mm) of resorbable collagen membrane (Biocollagen; Bioteck:Turin, Italy)were compacted toward the apex with premeasured suitable size schilder plugger. Moist cotton pellet was placed over the MTA followed by application of coronal seal. After 48 h, the set of the MTA was checked and final obturation of the root canal was done

Group Type: EXPERIMENTAL

Apexification

Intervention Type: PROCEDURE

MTA

Intervention Type: DRUG

Apical matrix

Intervention Type: DRUG

collagen membrane (Biocollagen; Bioteck:Turin, Italy)

Interventions

Apexification

Intervention Type: PROCEDURE

MTA

Intervention Type: DRUG

Ca(OH)2

Intervention Type: DRUG

Apical matrix

collagen membrane (Biocollagen; Bioteck:Turin, Italy)

Intervention Type: DRUG

Other Intervention Names

Proroot MTA; Ca(OH)2 dressing; internal matrix

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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Al-Azhar University

OTHER

Sponsor Role: lead

Responsible Party

Maha A Elhussiny , Phd

lecturer of Endodontic in faculty of dentistry Al-Azhar university for girls

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mervat IB Fawzy, Professor

Role: STUDY_DIRECTOR

Professor of Endodontics AL-Azhar university

Other Identifiers

REC 61

Identifier Type: -

Identifier Source: org_study_id