Vital Pulp Therapy in Carious Teeth With Hypomineralization

Not Applicable

Completed

• Conditions: Molar Incisor Hypomineralization; Dental Caries Extending to Pulp

• Registration Number: NCT03735069
• Lead Sponsor: Jordan University of Science and Technology

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 Timeline

• Study Start: 2017-09-12
• Study First Submitted: 2018-11-04
• Study First Submitted QC: 2018-11-06
• Study First Posted: 2018-11-08
• Primary Completion: 2019-11-15
• Study Completion: 2020-01-30
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-10
• Last Update Posted: 2020-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Clinical Success	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	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

Trial Locations

Locations (1)

Jordan University of Science and Technology; 🇯🇴 Irbid, Jordan