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

NCT ID: NCT03490422

Last Updated: 2018-04-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2014-07-31

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pulpotomy

Pulpotomy is performed in carious-exposed pulp in mature permanent teeth

Group Type: EXPERIMENTAL

Pulpotomy

Intervention Type: PROCEDURE

Pulpotomy in mature carious permanent teeth

Interventions

Pulpotomy

Pulpotomy in mature carious permanent teeth

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National University Health System, Singapore

OTHER

Sponsor Role: lead

Responsible Party

Dr Victoria Yu

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Victoria Yu, PhD

Role: PRINCIPAL_INVESTIGATOR

NUHS

Other Identifiers

R-221-000-060-112

Identifier Type: -

Identifier Source: org_study_id