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Clinical Trials/NCT03735069
NCT03735069
Completed
Not Applicable

Outcome of Vital Pulp Therapy in Carious Teeth With Hypomineralization Defects: a Clinical Study

Jordan University of Science and Technology1 site in 1 country62 target enrollmentStarted: September 12, 2017Last updated:

Overview

Phase
Not Applicable
Status
Completed
Enrollment
62
Locations
1
Primary Endpoint
Clinical Success

Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
6 Years to 16 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

Clinical Success

Time Frame: 12 months

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

Time Frame: 12 months

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 Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ola B. Al-Batayneh

Associate Professor

Jordan University of Science and Technology

Study Sites (1)

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