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

Dental Pulp Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02137967
• Other study ID #: 201105091RB
• Status: Recruiting
• Phase: Phase 0
• First received: January 2, 2012
• Last updated: May 13, 2014
• Start date: August 2011
• Est. completion date: June 2016

Study information

• Verified date: May 2014
• Source: National Taiwan University Hospital
• Contact: Hsiao-Hua Chang, phD
• Phone: 886-972651572
• Email: hhchangpedo[@]gmail.com
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

Description:

As Brief summary.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 2016
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Months to 9 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dental Pulp Disease
• Dental Pulp Diseases

Intervention

Procedure:
• NaOCl pulpotomy
Use 2.5% NaOCl as pulpotomy medicament for primary molars
• FC pulpotomy
Use 20% Formocresol as pulpotomy medicament for primary molars

Drug:
• 2.5% NaOCl

• 20% Formocresol

Locations

Country	Name	City	State
Taiwan	Pediatric dental department, National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No