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

NCT03522051 | Completed

• 1 other identifier: JUST14-4-2018
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulpotomy

Keywords

teeth; pulpitis; deep caries; pulpotomy; Mineral Trioxide Aggregate (MTA)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Periapical normalcy at follow up radiographs .

  6months , 1 year, 2, 3,4,5 years

• The tooth and restoration should be present in the mouth

  3, 6 months, 1 year, 2, 3,4,5 years

Study Arms (1)

Patients with carious teeth

EXPERIMENTAL

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.

Other: calcium silicate based material,

Interventions

calcium silicate based material, OTHER

Its a dental pulp capping material which is biocompatable and induces hard tissue barrier formation

Also known as: Neo MTA plus, Avalon Biomed

Patients with carious teeth

Eligibility Criteria

• Age: 7 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Jordan University of Science and Technology: lead

Study Sites (1)

Jordan University of science and technology

Irbid, 22110, Jordan

Location

Related 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.

  PMID: 29397003 BACKGROUND

• 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.

  PMID: 28673494 BACKGROUND

• 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.

  PMID: 26715408 BACKGROUND

MeSH Terms

Conditions

Pulpitis

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Nessrin A Taha, PhD

  Jordan University of Science and Technology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 19, 2018
• First Posted: May 11, 2018
• Study Start: December 1, 2016
• Primary Completion: June 1, 2019
• Study Completion: August 20, 2021
• Last Updated: September 16, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

JO (1)