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

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.

Study Overview

• Status: Completed
• Conditions: Apexification; Pulp Necrosis
• Intervention / Treatment: Procedure: Apexification; Drug: Ca(OH)2; Drug: Apical matrix; Drug: MTA

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.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 2; Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 14 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Procedure: Apexification; Drug: Ca(OH)2; Other Names: Ca(OH)2 dressing
Experimental: 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.	Procedure: Apexification; Drug: Ca(OH)2; Other Names: Ca(OH)2 dressing; Drug: Apical matrix; collagen membrane (Biocollagen; Bioteck:Turin, Italy); Other Names: internal matrix
Active Comparator: 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	Procedure: Apexification; Drug: MTA; Other Names: Proroot MTA
Experimental: 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	Procedure: Apexification; Drug: Apical matrix; collagen membrane (Biocollagen; Bioteck:Turin, Italy); Other Names: internal matrix; Drug: MTA; Other Names: Proroot MTA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Change in periapical pathosis	Change in periapical bone density on follow up radiographs to assess the healing process	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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-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	12 months

Collaborators and Investigators

• Sponsor: Al-Azhar University
• Investigators: Study Director: Mervat IB Fawzy, Professor, Professor of Endodontics AL-Azhar university

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2013
• Primary Completion (Actual): April 20, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: January 4, 2019
• First Submitted That Met QC Criteria: February 20, 2019
• First Posted (Actual): February 21, 2019

Study Record Updates

• Last Update Posted (Actual): February 21, 2019
• Last Update Submitted That Met QC Criteria: February 20, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Open apex; Immature teeth; Non vital pulp; Apical plug; Internal matrix
• Additional Relevant MeSH Terms: Pathologic Processes; Stomatognathic Diseases; Tooth Diseases; Dental Pulp Diseases; Necrosis; Dental Pulp Necrosis
• Other Study ID Numbers: REC 61

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No