NCT03735069

Vital Pulp Therapy in Carious Teeth With Hypomineralization

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Jordan University of Science and Technology · Academic / Other
• Sex: All
• Age: 6 Years – 16 Years
• Healthy volunteers: Accepted

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.

Conditions

• Dental Caries Extending to Pulp
• Molar Incisor Hypomineralization

Interventions

Type	Name	Description
PROCEDURE	IPT (Indirect pulp treatment)	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).
PROCEDURE	Cvek/partial pulpotomy	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.
PROCEDURE	Cervical pulpotomy	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.

Timeline

• Start date: 2017-09-12
• Primary completion: 2019-11-15
• Completion: 2020-01-30
• First posted: 2018-11-08
• Last updated: 2020-02-12

Locations

1 site across 1 country: Jordan