Ignite Creation Date:
2024-05-06 @ 12:20 PM
Last Modification Date:
2024-10-26 @ 12:57 PM
Study NCT ID:
NCT03735069
Status:
COMPLETED
Last Update Posted:
2020-02-12
First Post:
2018-11-04
Brief Title:
Vital Pulp Therapy in Carious Teeth With Hypomineralization
Sponsor:
Jordan University of Science and Technology
Organization:
Jordan University of Science and Technology
Study Overview
Official Title:
Outcome of Vital Pulp Therapy in Carious Teeth With Hypomineralization Defects a Clinical Study
Status:
COMPLETED
Status Verified Date:
2020-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 pulpectomyroot 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None