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

Pulpitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03490422
• Other study ID #: R-221-000-060-112
• Status: Completed
• Phase: N/A
• First received: March 26, 2018
• Last updated: March 30, 2018
• Start date: October 2013
• Est. completion date: July 2014

Study information

• Verified date: March 2018
• Source: National University Health System, Singapore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Pulpotomy
Pulpotomy in mature carious permanent teeth

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National University Health System, Singapore

Outcome

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