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Vital Pulp Therapy in Carious Teeth With Hypomineralization

Primary Purpose

Dental Caries Extending to Pulp, Molar Incisor Hypomineralization

Status
Completed
Phase
Not Applicable
Locations
Jordan
Study Type
Interventional
Intervention
IPT (Indirect pulp treatment)
Cvek/partial pulpotomy
Cervical pulpotomy
Sponsored by
Jordan University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Caries Extending to Pulp focused on measuring Vital pulp therapy, Indirect pulp treatment, Partial (Cvek) pulpotomy, Complete (cervical) pulpotomy, Enamel hypomineralization defects, Molar incisor hypomineralization, Children

Eligibility Criteria

6 Years - 16 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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)

Exclusion Criteria:

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

Sites / Locations

  • Jordan University of Science and Technology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

IPT (Indirect pulp treatment) group

Cvek/partial pulpotomy group

Cervical pulpotomy group

Arm Description

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).

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.

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.

Outcomes

Primary Outcome Measures

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)
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

Secondary Outcome Measures

Full Information

First Posted
November 4, 2018
Last Updated
February 10, 2020
Sponsor
Jordan University of Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT03735069
Brief Title
Vital Pulp Therapy in Carious Teeth With Hypomineralization
Official Title
Outcome of Vital Pulp Therapy in Carious Teeth With Hypomineralization Defects: a Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
September 12, 2017 (Actual)
Primary Completion Date
November 15, 2019 (Actual)
Study Completion Date
January 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jordan University of Science and Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Background: One of the greatest challenges that may affect the integrity of teeth is dental caries. If left untreated, pulpal involvement may occur leading to irreversible damage and eventually necrosis. This risk is greatly increased in the presence of developmental defects affecting tooth enamel such as molar-incisor hypomineralization (MIH). Despite having high success rate, root canal treatment will lead to loss of proprioceptive function, loss of stress-reducing damping property and tooth sensitivity in developed teeth and will also inhibit complete root formation in immature permanent teeth. 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. So, it has been advocated as a better alternative for pulpectomy/root canal treatment in deep carious vital permanent teeth. Aim: 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. Materials and methods: The study will be a prospective case series study including children between 6-16 years old. Inclusion criteria include patients having tooth with enamel hypomineralization defect with deep caries. Teeth should be restorable tooth. No soft tissue swellings, mobility or tenderness to percussion should be present. In cases of pulpotomy, bleeding from all canals should be present after opening the access. Tooth should be diagnosed with reversible / irreversible pulpitis (as indicated by positive response to cold testing). Medically compromised patients will be excluded from the study. Also any tooth that is non-restorable, having sinus tract or periodontally compromised will be excluded. The procedure involves taking preoperative compete records (radiograph, vitality tests, percussion, mobility and photographs). After administration of anesthetic agent, rubber dam will be placed, caries is removed and appropriate dressing pulp material will be placed and then the final restoration is placed. A post-operative x-ray will be taken. The teeth will be followed up both clinically and radiographically for 1 year after treatment. Expected Results: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IPT (Indirect pulp treatment) group
Arm Type
Experimental
Arm Description
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).
Arm Title
Cvek/partial pulpotomy group
Arm Type
Experimental
Arm Description
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.
Arm Title
Cervical pulpotomy group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
IPT (Indirect pulp treatment)
Other Intervention Name(s)
Indirect pulp capping
Intervention Description
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).
Intervention Type
Procedure
Intervention Name(s)
Cvek/partial pulpotomy
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Cervical pulpotomy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Clinical Success
Description
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)
Time Frame
12 months
Title
Radiographic Success
Description
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
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: Medically compromised patient Non-restorable tooth Presence of dental abcess / sinus tract Periodontally compromised teeth
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ola Al-Batayneh
Organizational Affiliation
Jordan University of Science and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jordan University of Science and Technology
City
Irbid
ZIP/Postal Code
22110
Country
Jordan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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Vital Pulp Therapy in Carious Teeth With Hypomineralization

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