Assessment of Vital Pulp Therapy in Permanent Molars

Study Overview
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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

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.

Official Title
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Clinical Evaluation of Vital Pulp Therapy in Young Permanent Molars With Irreversible Pulpitis

Conditions
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Dental Caries Extending to Pulp, Pulp Disease, Dental

Intervention / Treatment
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* Device: NeoMTA


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NeoMTA<br>Vital pulp therapy with NeoMTA | Device: NeoMTA<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical evaluation of vital pulp therapy in permanent teeth with irreversible pulpitis | Long-term success of vital pulp therapy in young permanent teeth with irreversible pulpitis. Evaluation criteria will be; spontaneous pain (absent/present); tenderness to percussion/palpation (absent/present); mobility (no mobility/ 1mm/ 2mm/ 3mm mobility) swelling (absent/present); fistula (absent/present) periapical/interradicular radiolucency (absent/present); widened periodontal ligament (absent/present); loss of lamina dura (absent/present); internal/external root resorption (absent/present). | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MTA, Permanent teeth, Vital pulp therapy