Clinical trial NCT03522051: Assessment of Pulpotomy Procedure Using NeoMTA Plus in Permanent Teeth With Carious Exposure
Official title: Assessment of Pulpotomy Procedure Using NeoMTA Plus in Permanent Teeth With Carious Exposure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulpotomy
Keywords: teeth
pulpitis
deep caries
pulpotomy
Mineral Trioxide Aggregate (MTA)
Lead sponsor: Jordan University of Science and Technology
Sponsor class: OTHER
First posted: 2018-05-11
Enrollment: 109
Sex: ALL
Minimum age (years): 7
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients with symptomatic deep caries in a permanent molar tooth will receive pulpotomy treatment and placement of a calcium silicate based material (Neo MTA plus) over the pulp and followed by restoration.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Medically compromised patients
* Negative response to cold test
* Mobility
* Sinus tract
* Swelling
* Non restorable teeth or badly broken teeth

Primary outcomes:
measure: Change in pain symptoms
timeFrame: 2-3 days after the treatment, 3 months, 6 months and 12 months and afterwards up to 5 years.
Secondary outcomes:
measure: Periapical normalcy at follow up radiographs .
timeFrame: 6months , 1 year, 2, 3,4,5 years
measure: The tooth and restoration should be present in the mouth
timeFrame: 3, 6 months, 1 year, 2, 3,4,5 years
Other outcomes:
Locations:
city: Irbid
country: Jordan
facility: Jordan University of science and technology
Study officials:
affiliation: Jordan University of Science and Technology
name: Nessrin A Taha, PhD
role: STUDY_DIRECTOR
References:
citation: Taha NA, Abdelkhader SZ. Outcome of full pulpotomy using Biodentine in adult patients with symptoms indicative of irreversible pulpitis. Int Endod J. 2018 Aug;51(8):819-828. doi: 10.1111/iej.12903. Epub 2018 Feb 27.
citation: Taha NA, Khazali MA. Partial Pulpotomy in Mature Permanent Teeth with Clinical Signs Indicative of Irreversible Pulpitis: A Randomized Clinical Trial. J Endod. 2017 Sep;43(9):1417-1421. doi: 10.1016/j.joen.2017.03.033. Epub 2017 Jun 30.
citation: Taha NA, Ahmad MB, Ghanim A. Assessment of Mineral Trioxide Aggregate pulpotomy in mature permanent teeth with carious exposures. Int Endod J. 2017 Feb;50(2):117-125. doi: 10.1111/iej.12605. Epub 2016 Jan 30.