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

Not Applicable

Completed

• Conditions: Pulp Exposure, Dental; Pulpitis; Pulp and Periapical Tissue Disease
• Interventions: Procedure: Pulpotomy

• Registration Number: NCT03490422
• Lead Sponsor: National University Health System, Singapore

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.

Study Timeline

• Study Start: 2013-10
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2018-03
• Study First Submitted: 2018-03-26
• Study First Submitted QC: 2018-03-30
• Last Update Submitted: 2018-03-30
• Study First Posted: 2018-04-06
• Last Update Posted: 2018-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pulpotomy	Pulpotomy	Pulpotomy is performed in carious-exposed pulp in mature permanent teeth

Primary Outcome Measures

Name	Time	Method
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