search
Back to results

Alternative Treatment of Deep Carious Lesions Based on Biological Evidences

Primary Purpose

Caries, Dental

Status
Withdrawn
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Incomplete caries removal in primary teeth
Sponsored by
Hadassah Medical Organization
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Caries, Dental focused on measuring Primary tooth, Caries, Dental, Alternative treatment

Eligibility Criteria

5 Years - 8 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Hadassah Medical Organization

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Other

Arm Label

Complete caries removal

Incomplete caries removal

Arm Description

Control group

Test group

Outcomes

Primary Outcome Measures

The success of the alternative treatment of the deep carious lesion.

Secondary Outcome Measures

Full Information

First Posted
September 6, 2009
Last Updated
August 18, 2015
Sponsor
Hadassah Medical Organization
search

1. Study Identification

Unique Protocol Identification Number
NCT00973089
Brief Title
Alternative Treatment of Deep Carious Lesions Based on Biological Evidences
Official Title
Alternative Treatment of Deep Carious Lesions Based on Biological Evidences
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Withdrawn
Why Stopped
recruiting or enrolling participants has halted prematurely and will not resume
Study Start Date
May 2010 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hadassah Medical Organization

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Caries, Dental
Keywords
Primary tooth, Caries, Dental, Alternative treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Complete caries removal
Arm Type
No Intervention
Arm Description
Control group
Arm Title
Incomplete caries removal
Arm Type
Other
Arm Description
Test group
Intervention Type
Other
Intervention Name(s)
Incomplete caries removal in primary teeth
Other Intervention Name(s)
Indirect pulp capping
Intervention Description
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.
Primary Outcome Measure Information:
Title
The success of the alternative treatment of the deep carious lesion.
Time Frame
Half annually for three years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Hadassah Medical Organization
City
Jerusalem
Country
Israel

12. IPD Sharing Statement

Citations:
PubMed Identifier
18519994
Citation
Thompson V, Craig RG, Curro FA, Green WS, Ship JA. Treatment of deep carious lesions by complete excavation or partial removal: a critical review. J Am Dent Assoc. 2008 Jun;139(6):705-12. doi: 10.14219/jada.archive.2008.0252.
Results Reference
background

Learn more about this trial

Alternative Treatment of Deep Carious Lesions Based on Biological Evidences

We'll reach out to this number within 24 hrs