Vital Pulp Therapy in Carious Teeth With Hypomineralization

Jordan University of Science and Technology

Status: Completed

Conditions: Dental Caries Extending to Pulp; Molar Incisor Hypomineralization

Treatments: Procedure: IPT (Indirect pulp treatment); Procedure: Cervical pulpotomy; Procedure: Cvek/partial pulpotomy

Study type: Interventional

Funder types: Other

Identifiers

NCT03735069

77-2017

Details and patient eligibility

About

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.

Full 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.

Enrollment: 62 patients

Sex: All

Ages: 6 to 16 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

62 participants in 3 patient groups

IPT (Indirect pulp treatment) group

Experimental group

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).

Treatment:

Procedure: IPT (Indirect pulp treatment)

Cvek/partial pulpotomy group

Experimental group

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.

Treatment:

Procedure: Cvek/partial pulpotomy

Cervical pulpotomy group

Experimental group

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.

Treatment:

Procedure: Cervical pulpotomy