Alternative Treatment of Deep Carious Lesions Based on Biological Evidences

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Hadassah Medical Organization
Sponsor:
Information provided by (Responsible Party):
Moti Moskovitz, Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00973089
First received: September 6, 2009
Last updated: June 12, 2013
Last verified: June 2013
  Purpose

The purpose of this study is to evaluate the success rate of alternative treatment of deep carious lesions in asymptomatic primary teeth with no clinical nor radiographic signs of pulpal inflammation. The treatment includes leaving a thin layer of caries that is present near the pulp chamber and includes liner placement and tooth sealing. This alternative treatment is to be compared with the treatment provided today to these teeth, which includes complete removal of caries and probably includes pulpotomy and wide preparation of the tooth. The study also evaluates the cost-effectiveness of both methods of treatment of deep carious lesions.


Condition Intervention
Caries, Dental
Other: Incomplete caries removal in primary teeth

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Alternative Treatment of Deep Carious Lesions Based on Biological Evidences

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • The success of the alternative treatment of the deep carious lesion. [ Time Frame: Half annually for three years ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: May 2010
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Complete caries removal
Control group
Incomplete caries removal
Test group
Other: Incomplete caries removal in primary teeth
Comparison between the success rate and cost-effectiveness of complete caries removal in treatment of deep carious lesions that might include wide preparations and involve pulpotomy versus incomplete removal of caries and avoiding pulp treatment.
Other Name: Indirect pulp capping

Detailed Description:

The treatment provided today for deep carious lesions in deciduous teeth is complete removal of the soft caries, that can lead to a wide preparation and need of tooth pulpotomy if the caries reaches to the pulp chamber, even if the tooth is asymptomatic and shows no signs of pulpal inflammation (neither clinically nor radiographically). According to a number of recent evidence based researches, and only in selected cases, dentists were able to preserve the vitality of the pulp without complete removal of the caries present near the pulp chamber. A thin layer of caries near the pulp chamber is left, and a liner is placed (conservative treatment). The carious process is stopped when the tooth is sealed, and thus the tooth is saved without engaging with pulpotomy and wide preparation of the tooth. The purpose of this study is to evaluate the success rate of the conservative treatment of deep carious lesions versus the treatment provided today that includes complete removal of caries and probably includes pulpotomy and wide preparation of the tooth. The study also evaluates the cost-effectiveness of both methods of treatment of deep carious lesions.

  Eligibility

Ages Eligible for Study:   5 Years to 8 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy children
  • Patient's age is 5-8 years old at the time of the treatment
  • Primary molars presenting with deep carious lesions
  • Carious lesion reaching the inner half of the dentin,with absence of periapical or interradicular alterations as detected by radiographic examination.
  • Absence of spontaneous pain

Exclusion Criteria:

  • Subjects that are not ASA I
  • Lack of cooperation
  • Clinical or radiographic signs of pathology
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00973089

Contacts
Contact: Moti Moskovitz, DMD PhD motim@md.huji.ac.il

Locations
Israel
Hadassah Medical Organization Recruiting
Jerusalem, Israel
Contact: : Arik Tzukert, DMD    00 972 2 6776095    arik@hadassah.org.il   
Contact: Hadas Lemberg, PhD    00 972 2 6777572    lhadas@hadassah.org.il   
Principal Investigator: Moti Moskovitz, DMD, PhD         
Sponsors and Collaborators
Hadassah Medical Organization
  More Information

Publications:
Responsible Party: Moti Moskovitz, Clinical Senior Lecturer, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT00973089     History of Changes
Other Study ID Numbers: LSA001-HMO-CTIL
Study First Received: September 6, 2009
Last Updated: June 12, 2013
Health Authority: Israel: Ministry of Health

Keywords provided by Hadassah Medical Organization:
Primary tooth
Caries, Dental
Alternative treatment

Additional relevant MeSH terms:
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on July 26, 2014