Vital Pulp Therapy in Carious Teeth With Hypomineralization
Condition: Dental Caries Extending to Pulp; Molar Incisor Hypomineralization
MeSH terms: Dental Caries; Molar Hypomineralization; Dental Enamel Hypoplasia
Study type: Interventional

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.
    

Intervention name(s): IPT (Indirect pulp treatment); Cvek/partial pulpotomy; Cervical pulpotomy
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): 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).; 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.; 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.
Other intervention name(s): Indirect pulp capping
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention 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)
Primary purpose: Treatment
Keywords: Vital pulp therapy; Indirect pulp treatment; Partial (Cvek) pulpotomy; Complete (cervical) pulpotomy; Enamel hypomineralization defects; Molar incisor hypomineralization; Children