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

NCT03849222 | Completed Phase 2 DMC

• 1 other identifier: REC 61
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pulp Necrosis; Apexification

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• presence of a calcified apical barrier or not

  3, 6 and 12 months

• Periapical Lesion scored with periapical index ( PAI)

  12 months

Study Arms (4)

Ca(OH)2 Apexification

ACTIVE COMPARATOR

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

Ca(OH)2 Apexification with apical matrix

EXPERIMENTAL

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; Drug: Apical matrix

MTA Apexification

ACTIVE COMPARATOR

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

MTA Apexification with apical matrix

EXPERIMENTAL

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: MTA; Drug: Apical matrix

Interventions

Apexification PROCEDURE

Ca(OH)2 Apexification; Ca(OH)2 Apexification with apical matrix; MTA Apexification; MTA Apexification with apical matrix

MTA DRUG

Also known as: Proroot MTA

MTA Apexification; MTA Apexification with apical matrix

Ca(OH)2 DRUG

Also known as: Ca(OH)2 dressing

Ca(OH)2 Apexification; Ca(OH)2 Apexification with apical matrix

Apical matrix DRUG

collagen membrane (Biocollagen; Bioteck:Turin, Italy)

Also known as: internal matrix

Ca(OH)2 Apexification with apical matrix; MTA Apexification with apical matrix

Eligibility Criteria

• Age: 8 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Immature permanent maxillary anterior teeth
• Non vital pulp
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Al-Azhar University: lead

MeSH Terms

Conditions

Dental Pulp Necrosis

Interventions

Apexification; Pemetrexed; ProRoot MTA

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Root Canal Therapy; Endodontics; Dentistry; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Study Officials

• Mervat IB Fawzy, Professor

  Professor of Endodontics AL-Azhar university

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of Endodontic in faculty of dentistry Al-Azhar university for girls

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

Study Record Dates

• First Submitted: January 4, 2019
• First Posted: February 21, 2019
• Study Start: August 20, 2013
• Primary Completion: April 20, 2016
• Study Completion: September 1, 2016
• Last Updated: February 21, 2019

Record last verified: 2019-02