Pulpotomy Clinical Trial
Official title:
Indirect Pulp Capping Versus Pulpotomy With MTA for Treatment of Primary Molars With Deep Caries: An Equivalent Parallel Randomized Controlled Trial
Verified date | September 2022 |
Source | Minia University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of the current randomized controlled trial is to evaluate clinical and radiographic outcomes of indirect pulp capping and pulpotomy with MTA in treatment of primary teeth with deep caries over a 12-month follow-up period.
Status | Active, not recruiting |
Enrollment | 100 |
Est. completion date | November 2023 |
Est. primary completion date | November 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 3 Years to 6 Years |
Eligibility | Inclusion Criteria: - - 4 to 6 years old patients presented with deep carious lesions in primary molars. - Apparently healthy children (ASA I, II classification). - Co-operative children (Rating 3 & 4 according to Frankle classification) Exclusion Criteria: A) Clinical: - Non restorable primary molars. - Presence of clinical pathology. - Presence of mobility or tenderness to percussion. - Spontaneous pain. B) Radiographic: - Pre-operative radiographs showed external or internal root resorption. - Presence of furcal radiolucency. - Presence of periapical radiolucency or widened periodontal ligament space - More than one-third root resorption detected. |
Country | Name | City | State |
---|---|---|---|
Egypt | Minia University | Minya | |
Egypt | Minia University | Minya |
Lead Sponsor | Collaborator |
---|---|
Minia University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical and radiographic evaluation | The children will be recalled for postoperative clinical and radiographic assessment at the following intervals: 3, 6, 12 months the treatment will be considered successful if none of the following clinical or radiographic findings is present:
Clinical criteria: pain tenderness to palpation or percussion gingival swelling or sinus tract purulent exudate expressed from the gingival margin abnormal tooth mobility Radiographic criteria: periapical radiolucency widening in peridontal ligament space |
2 years follow up |
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