Assessment of Vital Pulp Therapy in Permanent Molars

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-01

Study Completion Date

2023-08-01

Brief Summary

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The purpose of this study is to evaluate the long term clinical performance of vital pulp therapy of young permanent teeth with irreversible pulpitis

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Detailed Description

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Permanent molar teeth meeting the inclusion criteria will be included into the study. Following local anaesthesia and dental dam application, caries excavation will be performed; and after exposure, the pulp will be amputated to the level of the canal orifices (full pulpotomy) using a sterile high-speed round bur under water coolant. After haemostasis is achieved, Mineral trioxide aggregate (MTA) will be gently placed over the pulp to a thickness of 2-3 mm and the tooth will be restored using glass ionomer cement and composite resin. A postoperative periapical radiograph will be taken. Patients will be reviewed at 6., 12., 24. and 36. months for clinical and radiographical success. The data will be analysed statistically using chi square test.

Conditions

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Dental Caries Extending to Pulp Pulp Disease, Dental

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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NeoMTA

Vital pulp therapy with NeoMTA

Group Type EXPERIMENTAL

NeoMTA

Intervention Type DEVICE

NeoMTA™ Plus® root and pulp treatment material is a powder/gel system with no resin. The components are an extremely fine powder primarily tricalcium and dicalcium silicate plus a water-based gel.

Interventions

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NeoMTA

NeoMTA™ Plus® root and pulp treatment material is a powder/gel system with no resin. The components are an extremely fine powder primarily tricalcium and dicalcium silicate plus a water-based gel.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients and parents of the patients who accept to participate and sign the informed consent
* Patients who have at least one vital permanent molar teeth with irreversible pulpitis symptoms
* Teeth which can be restorable after the treatment.
* Teeth which has good periodontal health and in the absence of sinus tracts or swelling.

Exclusion Criteria

* Patients and parents of the patients who does not accept to participate and sign the informed consent
* Teeth which have dentoalveolar or extraoral swelling
* Teeth which have periodontal disease, mobility or alveolar bone loss
* Teeth which are not restorable
* Patients who are not cooperative with the treatment

Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes