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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03735069
Other study ID # 77-2017
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 12, 2017
Est. completion date January 30, 2020

Study information

Verified date February 2020
Source Jordan University of Science and Technology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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Study Design


Intervention

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Locations

Country Name City State
Jordan Jordan University of Science and Technology Irbid

Sponsors (1)

Lead Sponsor Collaborator
Jordan University of Science and Technology

Country where clinical trial is conducted

Jordan, 

References & Publications (19)

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Outcome

Type Measure Description Time frame Safety issue
Primary Clinical Success 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)
12 months
Primary Radiographic Success 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
12 months
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