Partial Pulpotomy in Mature Permanent Teeth With Signs and Symptoms of Irreversible Pulpits

NCT04870398 | Completed

• 1 other identifier: 459/01.03.2021
• Study Type: interventional
• Target: 142
• Locations: 0 countries
• Sites: N/A

Brief Summary

The main purpose of the present study is to assess the outcome of partial pulpotomy by using two different bioactive materials, namely MTA \[MTA Angelus (Angelus, Londrina, Brazil) and Total Fill BC putty (FKG, La Chaux-de-Fonds, Switzerland) bioceramic material in mature teeth with deep caries and clinical symptoms indicative of irreversible pulpitis. A secondary aim is to evaluate whether age, tooth type and coronal restoration play a significant role on the outcome of partial pulpotomy in the evaluated cases.

Conditions

Irreversible Pulpitis

Outcome Measures

Primary Outcomes (1)

• Number of successful cases with vital and healthy pulp during the follow-up period

  The primary outcome will be defined clinically in the absence of pathologic signs and symptoms such as spontaneous or lingering pain, tenderness to percussion and swelling as well as the response to cold sensibility test. Radiographically, the assessment of periapical tissues will take place. If the periapical tissues were normal preoperatively, they should continue to be normal. If a periapical radiolucency was present preoperatively, then a complete healing of periapical tissues should be accomplished. Under the above conditions, the case will be considered successful. If a case presents severe spontaneous or lingering pain, tenderness or pain to percussion, swelling or sinus tract with persistence of periapical lesion or emergence of a new one, will be considered as failure.

  1-4 years

Secondary Outcomes (1)

• Assessment of pain after pulpotomy procedure using the Heft-Parker visual analog scale

  One week after the intervention

Study Arms (2)

MTA partial pulpotomy

ACTIVE COMPARATOR

Profound local anesthesia of the tooth and the surrounding tissues will be achieved The tooth will be isolated with a rubber dam and initial caries removal will be performed by using a sterile high speed diamond bur. The deeper layers of caries will be removed by using a series of different diameters sterile low speed burs. After complete caries removal and pulp tissue exposure, first cut of pulp tissue will be performed using a new sterile high speed diamond bur. After the inspection of the surgical field for residual caries and the irrigation of the cavity with physiologic saline solution, a sterile cotton pellet will be gently placed over the pulp tissue for 3 minutes. Once hemostasis is achieved, a blood-filled homogenous tissue without dark or yellowish areas will be considered essential for the placement of MTA. After the placement of MTA, a resin modified glass-ionomer cement will be placed over the capping material and the cavity will be sealed with resin-bonded composite

Procedure: Vital Pulp therapy-Partial pulpotomy

Total Fill partial pulpotomy

ACTIVE COMPARATOR

The tooth will be isolated with a rubber dam and initial caries removal will be performed by using a sterile high speed diamond bur. The deeper layers of caries will be removed by using a series of different diameters sterile low speed burs. After complete caries removal and pulp tissue exposure, first cut of pulp tissue will be performed using a new sterile high speed diamond bur. After the inspection of the surgical field for residual caries and the irrigation of the cavity with physiologic saline solution, a sterile cotton pellet will be gently placed over the pulp tissue for 3 minutes. Once hemostasis is achieved, a blood-filled homogenous tissue without dark or yellowish areas will be considered essential for the placement of Total Fill BC. After the placement of the material, a resin modified glass-ionomer cement will be placed over the capping material and the cavity will be sealed with resin-bonded composite

Procedure: Vital Pulp therapy-Partial pulpotomy

Interventions

Vital Pulp therapy-Partial pulpotomy PROCEDURE

Removal of inflamed pulp tissue, hemostasis and placement of pulpotomy material

MTA partial pulpotomy; Total Fill partial pulpotomy

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients older than 10 years old.
• Written consent after their update regarding the study and its aims.
• Noncontributory medical history.
• Extremely deep caries extending to the pulp chamber.
• Positive response to cold sensibility testing.
• Presence of spontaneous pain or provoked lingering pain to cold stimuli.
• No clinical signs of pulp necrosis such as swelling or presence of a sinus tract.
• Restorable and periodontally sound teeth.

You may not qualify if:

• Immature teeth.
• Cariously involved teeth with no response to pulp sensibility tests.
• No signs and symptoms of irreversible pulpitis.
• Bleeding not controlled in 10 minutes after partial pulpotomy.
• Teeth with no evidence of bleeding after communication with the pulp chamber (necrosis of the coronal pulp tissue)
• Teeth with the pulp chamber exposed to the oral environment.
• Detection of periodontal pocket with depth greater than 4mm.
• Teeth suspected for crack or incomplete crown fracture possibly responsible for pulp pathology.
• Medically compromised patients.

Sponsors & Collaborators

• National and Kapodistrian University of Athens: lead

Study Officials

• Giorgos N Tzanetakis

  Department of Endodontics, School of Dentistry, National and Kapodistrian University of Athens

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 24, 2021
• First Posted: May 3, 2021
• Study Start: January 5, 2017
• Primary Completion: April 23, 2021
• Study Completion: April 23, 2021
• Last Updated: May 3, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Ever
• Access Criteria: Partial pulpotomy