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

Clinical Evaluation of Sodium Hypochlorite Pulpotomies in Primary Molars: A Long-Term Follow-Up in Comparison With Conventional 20% Formocresol Pulpotomies

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.

Study Overview

• Status: Unknown
• Conditions: Dental Pulp Disease
• Intervention / Treatment: Procedure: NaOCl pulpotomy; Drug: 2.5% NaOCl; Procedure: FC pulpotomy; Drug: 20% Formocresol

Detailed Description

As Brief summary.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Hsiao-Hua Chang, phD; Phone Number: 886-972651572; Email: hhchangpedo@gmail.com

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Recruiting
    • Pediatric dental department, National Taiwan University Hospital
    • Contact: Hsiao-Hua Chang, phD; Phone Number: 886-972651572; Email: hhchangpedo@gmail.com
    • Principal Investigator: Hsiao-Hua Chang, phD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 7 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NaOCl pulpotomy; Use 2.5% NaOCl as pulpotomy medication	Procedure: NaOCl pulpotomy; Use 2.5% NaOCl as pulpotomy medicament for primary molars; Drug: 2.5% NaOCl
Active Comparator: FC pulpotomy; Use 20% Formocresol as pulpotomy medicament	Procedure: FC pulpotomy; Use 20% Formocresol as pulpotomy medicament for primary molars; Drug: 20% Formocresol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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; Asymptomatic, clinical score=1; Slight discomfort: percussion sensitivity; mobility>1mm but<2mm, clinical score=2; Minor discomfort :long-lasting chewing sensitivity; gingival swelling; periodontal pocket formation without exudate; mobility>2mm but<3mm, clinical score=3; 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Radiographic Findings	The outcome will be assessed then by radiographic findings. We can discriminate the result are successful or not by scoring the radiographic findings from1 to 5. Criteria for radiographic scoring; Dentinal bridge, clinical score=1, regeneration tissue response; No change, clinical score=2, no pathological changes; Pulp canal obliteration, clinical score=3, slight pathological changes, no clinical significance; Periodontal ligament widening, clinical score=3, slight pathological changes, no clinical significance; Internal root resorption (non-perforated), clinical score=4, minor pathological changes; External root resorption, clinical score=4, minor pathological changes; Internal root resorption (perforated), clinical score=4, minor pathological changes; Peri-radicular lesion, clinical score=5, major pathological changes, treatment needed	At 3, 6, 9, 12, 15, 18, 21 and 24 months post-treatment

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Hsiao-Hua Chang, phD, Assistant professor

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Anticipated): September 1, 2014
• Study Completion (Anticipated): June 1, 2016

Study Registration Dates

• First Submitted: January 2, 2012
• First Submitted That Met QC Criteria: May 13, 2014
• First Posted (Estimate): May 14, 2014

Study Record Updates

• Last Update Posted (Estimate): May 14, 2014
• Last Update Submitted That Met QC Criteria: May 13, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Dental Pulp Diseases
• Other Study ID Numbers: 201105091RB