CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 62 enrolled
Drug / intervention
IPT (Indirect pulp treatment) +2 moreprocedure
Likely dose
Not stated in record
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Search/NCT03735069
NCT03735069N/ACompleted

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

Jordan University of Science and Technology·interventional·Posted Nov 8, 2018·Updated Feb 12, 2020

In Brief

A clinical study evaluating IPT (Indirect pulp treatment), Cvek/partial pulpotomy, and 1 other intervention for Dental Caries Extending to Pulp and Molar Incisor Hypomineralization. Completed, enrolled 62 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesJordan
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedNov 8, 2018
Enrollment StartSep 12, 2017
Primary CompletionNov 15, 2019
Study CompletionJan 30, 2020
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 7.6 years ago

Interventions

IPT (Indirect pulp treatment)procedure

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 pulpotomyprocedure

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 pulpotomyprocedure

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.