Sodium Hypochlorite Pulpotomies in Primary Molars: Comparison With Conventional 20% Formocresol Pulpotomies

NCT02137967 | Unknown Early Phase 1

• 1 other identifier: 201105091RB
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Formocresol (FC) is the most universally taught and most widely used pulpotomy medicament in the primary teeth. However, concerns have been raised over the use of FC because of its toxicity and potential carcinogenicity. A substitution for FC has been investigated but evidence is lacking to conclude which is the most appropriate technique for pulpotomies in primary teeth. Sodium hypochlorite (NaOCl) has been used in root canal irrigant for more than 80 years, and it is at present the most popular irrigant in root canal treatment. Studies have showed that NaOCl is biological compatible and is a very good antimicrobial solution without being a pulpal irritant. Recent studies using sodium hypochlorite as pulpotomy medicament in primary molars showed promising results. In this project, the investigators propose a randomized clinical trial, which will be performed in Pediatric Dentistry Department of the National Taiwan University Hospital, to compare the treatment outcomes between NaOCl and FC in human primary molars needing pulpotomy treatment. The aim of this sudy is to determining weather NaOCl is a suitable replacement for FC in the pulpotomy of human primary molar teeth. To assess this aim, 200 healthy children from 2.5 to 9 year-old, who have at least one primary first or second molars diagnosed to receive pulpotomy treatment will be recruited in this project. The involved teeth will be randomly assigned to the control group (dilute 20% Formocresol (DFC)) or experimental group (2.5% NaOCl). At 3, 6, 9, 12, 15, 18, 21 and 24 months post-treatment, the randomly assigned teeth will be clinically and radiographically evaluated by blinded independent evaluators to the treatment group. The differences will be statistically analyzed using chi-square test, Fisher exact test, and t-test, using a statistical significance at p\<0.05.

Conditions

Dental Pulp Disease

Outcome Measures

Primary Outcomes (1)

• Change of Clinical Findings

  The outcome will be assessed first by clinical findings. We can discriminate the result are successful or not by scoring the clinical finding from 1 to 4 . Criteria for clinical scoring 1. Asymptomatic, clinical score=1 2. Slight discomfort: percussion sensitivity; mobility\>1mm but\<2mm, clinical score=2 3. Minor discomfort :long-lasting chewing sensitivity; gingival swelling; periodontal pocket formation without exudate; mobility\>2mm but\<3mm, clinical score=3 4. major discomfort: Late pathological changes; spontaneous pain; periodontal pocket formation with exudate; sinus tract; mobility≧3 mm; premature tooth loss due to pathology, clinical score=4

  At 3, 6, 9, 12, 15, 18, 21 and 24 months post-treatment

Secondary Outcomes (1)

• Change of Radiographic Findings

  At 3, 6, 9, 12, 15, 18, 21 and 24 months post-treatment

Study Arms (2)

NaOCl pulpotomy

EXPERIMENTAL

Use 2.5% NaOCl as pulpotomy medication

Procedure: NaOCl pulpotomy; Drug: 2.5% NaOCl

FC pulpotomy

ACTIVE COMPARATOR

Use 20% Formocresol as pulpotomy medicament

Procedure: FC pulpotomy; Drug: 20% Formocresol

Interventions

NaOCl pulpotomy PROCEDURE

Use 2.5% NaOCl as pulpotomy medicament for primary molars

NaOCl pulpotomy

FC pulpotomy PROCEDURE

Use 20% Formocresol as pulpotomy medicament for primary molars

FC pulpotomy

2.5% NaOCl DRUG

NaOCl pulpotomy

20% Formocresol DRUG

FC pulpotomy

Eligibility Criteria

• Age: 30 Months - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• healthy, American Society of Anesthesiologists (ASA) Physical Status classification system class I children
• age between 2.5 and 9 years old
• with one or more primary molars need pulpotomy treatment

You may not qualify if:

• children younger than 2.5 or older than 9 years of age

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

Pediatric dental department, National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Dental Pulp Diseases

Interventions

formocresol

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• Hsiao-Hua Chang, phD

  Assistant Professor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hsiao-Hua Chang, phD

CONTACT

886-972651572; hhchangpedo@gmail.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2012
• First Posted: May 14, 2014
• Study Start: August 1, 2011
• Primary Completion: September 1, 2014
• Study Completion: June 1, 2016
• Last Updated: May 14, 2014

Record last verified: 2014-05

Locations

TW (1)