Pulpotomy in Carious Permanent Mature Teeth: Pulp Survival and Risk Factors

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03490422

Enrollment

Registered

2018-04-06

Start date

2013-10-31

Completion date

2014-07-31

Last updated

2018-04-06

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

Conditions

Pulp and Periapical Tissue Disease, Pulp Exposure, Dental, Pulpitis

Keywords

pulpotomy, permanent teeth, deep caries management, risk factors, clinical indicators for pulpotomy

Brief summary

This Trial evaluated the extent of pulp survival following pulpotomy in the permanent tooth pulp exposed by caries and identify potential risk factors for pulpal complications.

Detailed description

Healthy patients ≥ 21 years old were recruited with informed consent. Inclusion criteria were symptomatic and asymptomatic periodontally sound teeth, positive response to pulp sensibility tests, pulp exposure by caries with bleeding, haemostasis achieved within 10 minutes and normal apical tissues. Under local anaesthesia and rubber dam isolation, caries was removed before pulpotomy. Pain complaint, clinical and radiographic data were collected during recalls for up to 3 years.

Interventions

PROCEDUREPulpotomy

Pulpotomy in mature carious permanent teeth

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

Patient factors: * Male and female at least 21 years of age * Healthy and ambulant * Mild diseases only and without substantive functional limitations * Able to return for scheduled recalls Tooth factors: * Deep caries leading to pulp exposure * With or without pre-operative spontaneous and/or aggravated pain * Positive response to Cold and Electric Pulp Tests * Positive bleeding on pulp exposure * Haemostasis within 10 minutes * Intact and continuous periodontal ligament space and dental lamina dura on radiograph

Exclusion criteria

Patient factors: * Younger than 21 years of age * Pregnant female * Poorly controlled systemic diseases e.g. diabetes mellitus, hypertension Tooth factors: * Extensive tooth structure loss requiring post and core retained restoration * Uncontrolled periodontal disease * Cracked tooth * Traumatized tooth * Haemostasis not achieved within 10 minutes

Design outcomes

Primary

Measure	Time frame	Description
Change in radiographic apical status	3 years	Change from Baseline Radiographic appearance of apical tissue at 6 months, 1 year, 2 years and 3 years

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026