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Outcomes of Direct Pulp Capping Using Either ProRoot MTA® or Biodentine™ in Permanent Teeth With Carious Pulp Exposure in 6-18-year-old Patients.

Outcomes of Direct Pulp Capping Using Either ProRoot MTA® or Biodentine™ in Permanent Teeth With Carious Pulp Exposure in 6-18-year-old Patients.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
TCTR
Registry ID
TCTR20170526003
Enrollment
Unknown
Registered
2017-05-26
Start date
2012-10-10
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

Cariuosly exposed young permanent tooth with diameter not more than 2.5 mm. Direct pulp capping&#44

Interventions

Direct pulp capping with proroot MTA,Direct pulp capping with Biodentine
Active Comparator Drug,Experimental Drug

Sponsors

Chiang Mai university
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 18 Years

Inclusion criteria

Inclusion criteria: Patient inclusion criteria 1. American Society of Anesthesiologists I or II (ASA I or II) pediatric patients aged between 6 and 18 years 2. Cooperative patients 3. The legal guardians allow the child participate and the child agrees to participate in the study and sign the informed consent and assent forms&#44; respectively Tooth clinical inclusion criteria Pre&#45;operative clinical inclusion criteria 1. Tooth with deep caries diagnosed with normal pulp&#44; reversible pulpitis or irreversible pulpitis 2. Tooth that has a positive response to sensibility test (cold test) 3. Tooth that is restorable with resin composite filling or stainless steel crown 4. Absence of clinical swelling&#44; pus exudate/ fistula of soft and periodontal tissues 5. Absence of abnormal tooth mobility Intra&#45;operative clinical inclusion criteria 1. After complete caries removal procedure&#44; exposure of pulpal tissue occurs 2. Size of pulp exposure is < 2.5 mm. in diameter 3. Pulp tissue appears healthy judged from color and amount of bleeding 4. Bleeding from pulp exposure site can be controlled within 10 minutes Radiographic inclusion criteria Bitewing radiograph 1. The extension of the dental caries radiolucency penetrates into three fourths or more of the entire dentin thickness Paralleled periapical radiograph 1. Absence of internal and pathologic external root resorption 2. Absence of pulp calcification pulp canal obliteration 3. Absence of periapical and furcation radiolucency Note: Presence of widened PDL space or evidence of condensing osteitis are not exclusion criteria for this study

Exclusion criteria

Exclusion criteria: Patient exclusion criteria Pediatric patients who have a systemic disease that is contraindicated for vital pulp therapy&#44; such as congenital heart disease&#44; bleeding disorder&#44; etc. Tooth clinical exclusion criteria Intra&#45;operative clinical exclusion criteria 1. After caries is completely removed&#44; no pulp exposure is detected by visual or tactile methods&#44; or pulp exposure size is larger than 2.5 mm. 2. Bleeding from pulp exposure site cannot be controlled within 10 minutes 3. Pulp tissue appears necrotic judged on the absence of bleeding or the presence of pale pulp tissue.

Design outcomes

Primary

MeasureTime frame
clinical and radiographic success 6&#44; 12&#44; 18&#44; 24&#44; 30&#44; 36 months clinical and radiographic evaluation

Secondary

MeasureTime frame
survival rate 6&#44; 12&#44; 18&#44; 24&#44; 30&#44; 36 months survival analysis

Countries

Thailand

Contacts

Public ContactPapimon Chompu&#45;inwai

Chiang Mai university

papimon.c@cmu.ac.th053944460

Outcome results

None listed

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