Evaluation of Clinical and Radiological Success of Vital Amputation Treatment

NCT03883295 | Unknown

• 1 other identifier: 352
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Total amputation therapy; is a treatment method aimed at maintaining the vitality of the radicular pulp remaining as a result of complete removal of coronal pulp tissue. In cases where pulp is exposed due to caries or trauma, the pulp is vital, bleeding can be controlled during the procedure, no periapical pathology is seen and radicular pulp is healthy. Traditionally, acute pulp pain is thought to be a symptom of irreversible pulpitis, and it is thought that there is little chance of the pulp returning to its normal situation after removal of the irritants. Root canal treatment has been accepted as the gold standard for the treatment of these symptoms. In recent studies, spontaneous or severe pain before procedure has not always indicated that pulp has no repair capacity, and deep carious lesions are not necessarily associated with irreversible pulpal pathology. Histological studies showed that even when caries reach the pulp or degeneration and inflammation were seen in it, there was a healthy section still present in the pulp. Therefore, it is stated that the healthy pulp remaining as a result of total amputation performed by removal of degenerated pulp can be preserved. Furthermore, it is stated that for the healing potential of the remaining pulp tissue, the original signal should be that the bleeding can be controlled after the amputation of the infected pulp tissue. While the most popular method in the treatment of vital pulp is CaOH, the American Academy of Pediatric Dentistry has been reported to be more resistant to dissolution in the protocol in recent years. MTA is a more suitable material because it is more homogeneous, and forms a thicker dentin bridge. However, the MTA requires a long time to harden, it is difficult to manipulate and color. In recent years, researchers have focused on creating new MTA formulations to improve their physicochemical properties without affecting their biocompatibility and bioactivity. NeoMTA Plus is a new fine powder tricalcium silicate. It consists of a water-based gel and powder mixture and the powder-gel mixing ratio may vary depending on the area of use. It is a material similar to MTA Plus. However, in order to avoid tooth discoloration, tantalium oxide used instead of the bismuth oxide and required calcium hydroxide used to induce the formation of mineralized tissue.

Conditions

Endodontic Inflammation; Pulp Disease, Dental

Outcome Measures

Primary Outcomes (3)

• Postoperative pain

  Using visual analogue scale by participant. It is usually presented as a 100-mm horizontal line on which the patient's pain intensity is represented by a point between the extremes of "no pain at all" and "worst pain imaginable". The scale has no other subscales.

  12 months

• Pulp sensibility

  Using cold and electric pulp testings by clinicians

  12 months

• Radiological evaluation

  Standardized periapical radiographs will be taken and monitored

  12 months

Study Arms (2)

Control

EXPERIMENTAL

root canal treatment will be initiated

Procedure: Control

NeoMTA Plus

EXPERIMENTAL

vital pulp treatment using neomta plus will be used.

Procedure: NeoMTA Plus

Interventions

Control PROCEDURE

The specimens will be root canal treated conventionally

Also known as: Conventional root canal treatment

Control

NeoMTA Plus PROCEDURE

The specimens will be subjected to vital pulp amputation using NeoMTA Plus.

Also known as: Pulp amputation

NeoMTA Plus

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Having a lower molar and lower/upper premolars diagnosed with irreversible pulpitis

You may not qualify if:

• Patients with systemic disease
• Negative outcome of pulp sensibility
• Patients presenting abscess

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

Study Sites (1)

Elif Kalyoncuoğlu

Samsun, 55139, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pulpitis; Dental Pulp Diseases

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• Ayça T Ulusoy Yamak

  ONDOKUZ MAYIS UNIVERSITY, FACULTY OF DENTISTRY DEPARTMENT OF PEDIATRIC DENTISTRY

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ELİF KALYONCUOĞLU, Phd

CONTACT

05057373766; elif_kalyoncu@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc.Prof

Study Record Dates

• First Submitted: March 18, 2019
• First Posted: March 20, 2019
• Study Start: November 1, 2018
• Primary Completion: December 15, 2019
• Study Completion: December 31, 2019
• Last Updated: March 25, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)