Assessment of Pulpotomy Procedure Using NeoMTA Plus in Permanent Teeth With Carious Exposure

Pulpotomy Clinical Trial

— PULPOTOMY  

Official title:

Assessment of Pulpotomy Procedure Using NeoMTA Plus in Permanent Teeth With Carious Exposure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03522051
• Other study ID #: JUST14-4-2018
• Status: Completed
• Phase: N/A
• Start date: December 1, 2016
• Est. completion date: August 20, 2021

Study information

• Verified date: September 2021
• Source: Jordan University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: August 20, 2021
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Pulpotomy

Intervention

Other:
• calcium silicate based material,
Its a dental pulp capping material which is biocompatable and induces hard tissue barrier formation

Locations

Country	Name	City	State
Jordan	Jordan University of science and technology	Irbid

Sponsors (1)

Lead Sponsor	Collaborator
Jordan University of Science and Technology

Country where clinical trial is conducted

Jordan, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in pain symptoms	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.	2-3 days after the treatment, 3 months, 6 months and 12 months and afterwards up to 5 years.
Secondary	Periapical normalcy at follow up radiographs .	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.	6months , 1 year, 2, 3,4,5 years
Secondary	The tooth and restoration should be present in the mouth	The tooth should be in the mouth and in function (not extracted) with an intact restoration at the follow up times	3, 6 months, 1 year, 2, 3,4,5 years