Pulp Exposure, Dental Clinical Trial
Official title:
Clinical and Radiographic Evaluation of Pulpotomy Technique for Preserving Vitality of Traumatized Anterior Permanent Immature Teeth: A Randomized Clinical Trial
Verified date | December 2019 |
Source | Cairo University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Aim of the study: To compare the clinical and radiographic outcomes of mineral trioxide
aggregate (MTA) and Biodentine as vital pulp therapy materials (pulpotomy) preserving the
vitality of traumatized immature anterior permanent teeth.
Materials and Methods: fifty vital traumatized immature anterior permanent teeth exposed with
symptomatic /asymptomatic pulpitis were included in the study according to inclusion criteria
and were equally divided in two groups. Included teeth were randomly assigned to either a
control group (MTA 25 teeth) or a test group (Biodentine 25 teeth). After conducting
pulpotomy and covering pulp stumps with the MTA and Biodentine, treated teeth received
permanent restorations. Blinded clinical and radiographic evaluations were performed at
different time intervals (base line immediate postoperative, 6, 12 and 18 months) according
to clinical and radiographic criteria of success. Data were recorded and analyzed.
Status | Completed |
Enrollment | 33 |
Est. completion date | August 15, 2019 |
Est. primary completion date | December 30, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 7 Years to 9 Years |
Eligibility |
Inclusion Criteria: - The patient age range 7.5-9 years. - Noncontributory medical history - Unilateral/ and or bilateral central incisors tooth with complicated trauma (exposure size = 1mm) - The tooth should give positive response to cold testing - Clinical diagnosis of reversible pulpitis without periapical rarefaction - The tooth is restorable, mobility was within normal limits - No signs of pulpal necrosis including sinus tract or swelling Exclusion Criteria: - Teeth with mature roots - Signs and symptoms of irreversible pulpitis - Non-restorable teeth - Negative response to cold testing, the presence of sinus tract or swelling - No pulp exposure - Bleeding could not be controlled after full pulpotomy in 6 minutes |
Country | Name | City | State |
---|---|---|---|
Egypt | Gihan Abuelniel | Giza |
Lead Sponsor | Collaborator |
---|---|
Gihan M Abuelniel ,PhD | Cairo University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | presence of pain,sensitivity to percussion/ palpation | by asking the patient( questionnaire) (Binary measure) ( Yes or No) where Yes indicates failure of the treatment | 18 months | |
Primary | Swelling or sinus tract | by visual examination (binary measure)( Yes or No) where Yes indicates clinical failure of the treatment | 18 months | |
Primary | presence of mobility | by the back of the mirror( Binary measure) (Yes or No) where Yes indicates clinical failure of the treatment. | 18 months | |
Secondary | Stage of root development | by radiographic parallel technique ( four root development stages are assessed E, F,G and H) where E is the worse and H is the best stage. | 18 months | |
Secondary | Presence of radiolucency | by radiographic parallel technique (Binary measure) (Yes or No) where Yes indicates radiographic failure of the treatment. | 18 months |
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