Vital Pulp Therapy in Carious Teeth With Hypomineralization

NCT03735069 | Completed

• 1 other identifier: 77-2017
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

Vital pulp therapy (VPT) is a general term for multiple procedures (indirect pulp cap, direct pulp cap and pulpotomy) all directed toward preserving pulp vitality and enable complete root development in immature teeth. The aim of this study is to evaluate the clinical, radiographic and histologic (if any teeth later are doomed for extraction for orthodontic or other reasons) success rate of VPT on treating cariously exposed permanent teeth with developmental defects of enamel. This will be a a prospective case series study including children between 6-16 years old having tooth with enamel hypomineralization defect with deep caries, restorable teeth , and no signs of infection. The teeth will be followed up both clinically and radiographically for 1 year after treatment. It is expected that the teeth will maintain vitality with resolution of symptoms (if present) and completion of root development in immature teeth after vital pulp therapy.

Conditions

Dental Caries Extending to Pulp; Molar Incisor Hypomineralization

Keywords

Vital pulp therapy; Indirect pulp treatment; Partial (Cvek) pulpotomy; Complete (cervical) pulpotomy; Enamel hypomineralization defects; Molar incisor hypomineralization; Children

Outcome Measures

Primary Outcomes (2)

• Clinical Success

  Clinical parameters indicating successful treatment include the following criteria: * Absence of symptoms (except on the first 24 hrs) * No tenderness to percussion * Normal soft tissue around the tooth (no swellings or sinus tract) * Reduction in PAI if rarefaction was present * Normal response to cold test * Continued root development (immature teeth)

  12 months

• Radiographic Success

  Radiographic parameters indicating successful treatment is based on the periapical index (PAI), and includes 5 scores from 1-5: PAI 1 - normal periapical structure PAI 2 - small changes in bone structure not pathognomic for apical periodontitis PAI 3 - changes in bone structure with some mineral loss characteristic of apical periodontitis PAI 4 - periodontitis with well defined radiolucent area PAI 5 - severe periodontitis with exacerbating features and bone expansion

  12 months

Study Arms (3)

IPT (Indirect pulp treatment) group

EXPERIMENTAL

In this group, complete caries excavation from the dentin-enamel junction will be done. Caries near the pulp will be removed with caution until the remaining dentin shows increased resistance to manual instrumentation. A layer of resin-modified glass ionomer (RMGI) dressing material will be placed (Vitrebond; St.Paul, MN), followed by resin-modified glass ionomer (RMGI) build-up material (Vitremer; St. Paul, MN), and the final restoration of choice for MIH involved teeth; a preformed Stainless Steel Crown (SSC).

Procedure: IPT (Indirect pulp treatment)

Cvek/partial pulpotomy group

EXPERIMENTAL

In this group, partial pulpotomy will be attempted first, inflamed pulp tissue will be removed until healthy pulp tissue is reached (2-4mm depth), as indicated by healthy bleeding and arrest of hemorrhage upon pressure with a cotton pellet moistened with 2.5% NaOCl for 2-5 minutes and repeated twice if required; otherwise, cervical pulpotomy will be done. Gray MTA (Mineral Trioxide Aggregate, Dentsply, Canada) will be placed in the pulp chamber (2-3mm thickness), a moist cotton pellet will be placed and Intermediate Restorative Material (IRM) to ensure setting. Patient will be reviewed after 1 week. If the tooth is asymptomatic, final restoration with RMGI (Vitremer; St. Paul, MN) and stainless steel crown will be placed , and a post-op radiograph will be taken.

Procedure: Cvek/partial pulpotomy

Cervical pulpotomy group

EXPERIMENTAL

In this group, a cervical pulpotomy procedure will be done where all pulp chamber tissue shall be removed until healthy pulp tissue is reached, as indicated by bleeding from all canals and arrest of hemorrhage upon pressure (for maximum 6 minutes). Gray MTA (Mineral Trioxide Aggregate, Dentsply, Canada) will be mixed according to manufacturer instructions and will be placed in the pulp chamber in 2-3 mm thickness, moist cotton pellet will be placed to ensure setting and the tooth will be temporized with Intermediate Restorative Material (IRM), the patient will be reviewed after 1 week. If the tooth is asymptomatic, final restoration with RMGI (Vitremer; St. Paul, MN) and stainless steel crown will be placed , and a post-op radiograph will be taken.

Procedure: Cervical pulpotomy

Interventions

IPT (Indirect pulp treatment) PROCEDURE

Indirect pulp treatment involves complete caries excavation from the dentin-enamel junction using a round bur. Caries near the pulp is removed with caution using spoon excavator until the remaining dentine shows increased resistance to manual instrumentation. A layer of resin-modified glass ionomer (RMGI) dressing material is placed, followed by resin-modified glass ionomer (RMGI) build-up material, and the final restoration; a preformed Stainless Steel Crown (SSC).

Also known as: Indirect pulp capping

IPT (Indirect pulp treatment) group

Cvek/partial pulpotomy PROCEDURE

Cvek/partial pulpotomy involves removal of inflamed pulp tissue to depth until healthy pulp tissue is reached (depth of 2-4 mm), as indicated by healthy bleeding and arrest of hemorrhage upon pressure with a cotton pellet moistened with 2.5% NaOCl for 2-5 minutes and repeated for two times if required. Gray MTA will be placed in the pulp chamber in 2-3 mm thickness, moist cotton pellet will be placed to ensure setting and the tooth will be temporized with IRM, the patient will be reviewed after 1 week. If the tooth is asymptomatic, final restoration with RMGIC and stainless steel crown will be placed , and a post-operative radiograph will be taken.

Cvek/partial pulpotomy group

Cervical pulpotomy PROCEDURE

Cervical pulpotomy involves removal of inflamed pulp tissue from all pulp chamber as indicated by healthy bleeding and arrest of hemorrhage upon pressure with a cotton pellet moistened with 2.5% NaOCl for 6 minutes and repeated for two times if required. Gray MTA will be placed in the pulp chamber (2-3mm) thickness, moist cotton pellet will be placed to ensure setting and the tooth will be temporized with IRM, the patient will be reviewed after 1 week. If the tooth is asymptomatic, final restoration with RMGIC and stainless steel crown will be placed , and a post-operative radiograph will be taken.

Cervical pulpotomy group

Eligibility Criteria

• Age: 6 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy patient between 6-16 years.
• Tooth with enamel hypomineralization defect
• Molar tooth with deep caries
• Restorable molar tooth
• No soft tissue swellings, mobility or tenderness to percussion
• Bleeding from all canals (when performing cervical pulpotomy)
• Reversible / Irreversible pulpitis (as indicated by positive response to pulp testing using cold test)

You may not qualify if:

• Medically compromised patient
• Non-restorable tooth
• Presence of dental abcess / sinus tract
• Periodontally compromised 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 (19)

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MeSH Terms

Conditions

Molar Hypomineralization

Interventions

adenylate isopentenyltransferase

Condition Hierarchy (Ancestors)

Dental Enamel Hypomineralization; Developmental Defects of Enamel; Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Ola Al-Batayneh

  Jordan University of Science and Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: The study will be a prospective case series study; VPT (IPT, partial or complete pulpotomies) will be done depending on the severity of the case (depth of caries/pulpal involvement, symptoms and response to vitality testing). The study will include about 150 hypomineralized first permanent molars, patients age will range from 6-16 years old. Sample will be divided into 3 groups according to the treatment that will be provided (IPT / Cvek pulpotomy / Cervical pulpotomy). Patients' teeth will be randomly allocated to different treatment procedures (IPT or pulpotomy) using random tables.

Study Record Dates

• First Submitted: November 4, 2018
• First Posted: November 8, 2018
• Study Start: September 12, 2017
• Primary Completion: November 15, 2019
• Study Completion: January 30, 2020
• Last Updated: February 12, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

JO (1)