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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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
TCTR
Registry ID
TCTR20181121001
Enrollment
360
Registered
2018-11-21
Start date
2018-11-20
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carious pulp exposure

Interventions

irrigate the pulp tissue with sodium hypochlorite,irrigate the pulp tissue with normal saline solution
Experimental Drug,Experimental Drug
Sodium hypochlorite,Normal saline solution

Sponsors

Faculty of Dentistry CMU
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 18 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
Success at least 6 months Clinical and radiographic assessment

Secondary

MeasureTime frame
discoloration at least 6 months clinical assessment

Countries

Thailand

Contacts

Public ContactPapimon Chompu-inwai

Faculty of Dentistry Chiang Mai university

papimon.c@cmu.ac.th053944460

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026