Assessment of Pulpotomy Procedure Using NeoMTA Plus in Permanent Teeth With Carious Exposure
- Conditions
- Pulpotomy
- Interventions
- Other: calcium silicate based material,
- Registration Number
- NCT03522051
- Lead Sponsor
- Jordan University of Science and Technology
- Brief Summary
Many deep carious teeth are treated unnecessarily by root canal therapy, while with using current techniques and advances in compatible dental materials in addition to better understanding of biological response of the dental pulp, many can be treated conservatively via vital pulp therapy procedures.
- Detailed Description
Vital pulp therapy is recommended for teeth diagnosed with reversible pulpitis or partially inflamed pulps in which the remaining healthy tissue can be conserved and protected by a biologically active material to generate a hard tissue barrier that seals and protects the pulp from future microbial insult.
The aim of this in vivo study is to clinically and radiographically assess the outcome of full pulpotomy using a calcium silicate based material (NeoMTA Plus) in permanent teeth with carious exposure.
Ethics approval was obtained from the institutional ethics and research committee, and the patients were informed about details of the treatment and the possible complications. An informed consent was obtained. 120 patients meeting the inclusion criteria will be selected for this study and they will be subsequently followed up clinically and radiographically after 3 months, 6 months, 1 year and yearly afterward for 5 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 109
- Permanent teeth with mature or immature apices
- Have no significant medical problems
- The tooth should give positive response to cold test and electric pulp test (EPT)
- Probing pocket depth and mobility within normal limits
- No Signs of pulp necrosis including sinus tract or swelling
- Radiographically ; caries either exposing the pulps or reaching more than 2\3 the distance from the dentino-enamel junction (DEJ) to the pulp
- The tooth can be restored via direct restoration
- Medically compromised patients
- Negative response to cold test
- Mobility
- Sinus tract
- Swelling
- Non restorable teeth or badly broken teeth
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Patients with carious teeth calcium silicate based material, female or male patients with permanent teeth and deep caries will receive pulpotomy treatment and dressing with calcium silicate based material (Neo MTA plus material) followed by restoration.
- Primary Outcome Measures
Name Time Method Change in pain symptoms 2-3 days after the treatment, 3 months, 6 months and 12 months and afterwards up to 5 years. The patient is anticipated to report reduction in the pain score after receiving the treatment within 2-3 days and the tooth should continue to be asymptomatic at follow up appointments. The patient will be asked to score the pain level on visual analogue scale using a score from 0-10. The zero is no pain while 10 is the maximum level.
- Secondary Outcome Measures
Name Time Method The tooth and restoration should be present in the mouth 3, 6 months, 1 year, 2, 3,4,5 years The tooth should be in the mouth and in function (not extracted) with an intact restoration at the follow up times
Periapical normalcy at follow up radiographs . 6months , 1 year, 2, 3,4,5 years Pr-existing pathology should heal within 6 months- 1 year and normalcy should be maintained after ward up to 5 years.
no emerging pathosis should be evident in the roots or surrounding bone.
Trial Locations
- Locations (1)
Jordan University of science and technology
🇯🇴Irbid, Jordan