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

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.

Study Overview

• Status: Completed
• Conditions: Pulpitis; Pulp Exposure, Dental; Pulp and Periapical Tissue Disease
• Intervention / Treatment: Procedure: Pulpotomy

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 Type: Interventional
• Enrollment (Actual): 53
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Pulpotomy; Pulpotomy is performed in carious-exposed pulp in mature permanent teeth	Procedure: Pulpotomy; Pulpotomy in mature carious permanent teeth

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: National University Health System, Singapore
• Investigators: Principal Investigator: Victoria Yu, PhD, NUHS

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2013
• Primary Completion (ACTUAL): July 1, 2014
• Study Completion (ACTUAL): July 1, 2014

Study Registration Dates

• First Submitted: March 26, 2018
• First Submitted That Met QC Criteria: March 30, 2018
• First Posted (ACTUAL): April 6, 2018

Study Record Updates

• Last Update Posted (ACTUAL): April 6, 2018
• Last Update Submitted That Met QC Criteria: March 30, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: risk factors; pulpotomy; permanent teeth; deep caries management; clinical indicators for pulpotomy
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Dental Pulp Diseases; Pulpitis; Dental Pulp Exposure
• Other Study ID Numbers: R-221-000-060-112

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No