Success rates of vital pulp therapy using mineral trioxide aggregate with either sodium hypochlorite or normal saline solution as an irrigant and hemostatic agent in permanent teeth of 6-18-year-old patients
- Conditions
- Carious pulp exposure
- Registration Number
- TCTR20181121001
- Lead Sponsor
- Faculty of Dentistry CM
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 360
Inclusion criteria
Patient inclusion criteria
1. American Society of Anesthesiologists I or II (ASA I or II) pediatric patients aged between 6-18 years old.
2. Cooperative patients
3. The legal guardians allow the child to participate and the child agrees to participate in the study and sign the informed consent and assent forms, respectively
Tooth clinical inclusion criteria
Pre-operative clinical inclusion criteria
1. Tooth with deep caries
2. Tooth that has a positive response to sensibility test.
3. Tooth that is restorable with resin composite or stainless steel crown.
4. Absence of clinical swelling, pus exudate/ fistula of soft and periodontal tissues.
5. Absence of abnormal tooth mobility.
Intra-operative clinical inclusion criteria
1. After complete caries removal, pulp tissue appears vital judging from color and amount of bleeding.
2. Bleeding from pulp exposure site can be controlled within 10 minutes.
Radiographic criteria
A. Radiographic inclusion criteria
Bitewing radiograph
1. The extension of the dental caries radiolucency penetrates into three fourth or more of the entire dentin thickness.
Paralleled periapical radiograph
1. No prominent radiolucency at the furcation or periapical regions
2. Absence of internal and/or pathologic external root resorption
3. Absence of calcification/ or pulp canal obliteration
Note: The presence of early periapical lesions, such as widened periodontal ligament (PDL) space or condensing osteitis was not considered an exclusion criteria for this study
Exclusion criteria
Patient exclusion criteria
Pediatric patients who have systemic disease or contraindicated for vital pulp therapy such as congenital heart disease, bleeding disorder, etc.
Tooth clinical exclusion criteria
1. Bleeding from pulp exposure site cannot be controlled within 10 minutes.
2. Pulp tissue appears necrotic judged on
- The absence of bleeding
- The presence of pale pulp tissue
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Success at least 6 months Clinical and radiographic assessment
- Secondary Outcome Measures
Name Time Method discoloration at least 6 months clinical assessment