The Influence of Bisphosphonates in the Oral Cavity in Children
Primary Purpose
Oral Cavity, Osteomyelitis, Necrosis of the Jaws
Status
Completed
Phase
Locations
Israel
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Oral Cavity focused on measuring bisphosphonates, children, dental, Osteomyelitis, medication
Eligibility Criteria
Inclusion Criteria:
- children treated with bisphosphonate
Sites / Locations
- Hadassah scool of Dental Medicine
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00402064
First Posted
November 20, 2006
Last Updated
January 28, 2009
Sponsor
Hadassah Medical Organization
1. Study Identification
Unique Protocol Identification Number
NCT00402064
Brief Title
The Influence of Bisphosphonates in the Oral Cavity in Children
Official Title
The Influence of Bisphosphonates in the Oral Cavity in Children
Study Type
Observational
2. Study Status
Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2008 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Hadassah Medical Organization
4. Oversight
5. Study Description
Brief Summary
The use of bisphosphonates during childhood to ameliorate the skeletal abnormalities associated with osteogenesis imperfecta, idiopathic juvenile osteoporosis, fibrous dysplasia of bone and cerebral palsy. There is paucity of long-term studies among children regarding the safety and efficacy of bisphosphonates.
Osteomyelitis and necrosis of the jaws has been was discovered and reported as a serious adverse event in bisphosphonate-treated adults patients.
To our knowledge, there is no report in the literature about osteomyelitis in children treated with bisphosphonates and the influence of long term treatment with bisphosphonates on children's jaws, the reaction to extractions and on the oral cavity.
Aim of the study: to examine the influence in the oral cavity of bisphosphonate in children
Detailed Description
The use of bisphosphonates during childhood to ameliorate the skeletal abnormalities associated with osteogenesis imperfecta, idiopathic juvenile osteoporosis, fibrous dysplasia of bone and cerebral palsy. There is paucity of long-term studies among children regarding the safety and efficacy of bisphosphonates.
Osteomyelitis and necrosis of the jaws has been was discovered and reported as a serious adverse event in bisphosphonate-treated adults patients.
To our knowledge, there is no report in the literature about osteomyelitis in children treated with bisphosphonates and the influence of long term treatment with bisphosphonates on children's jaws, the reaction to extractions and on the oral cavity Aim of the study: to examine the influence in the oral cavity of bisphosphonate in children Materials and methods Population: 50 children treated with bisphosphonate will be included in the study.
The following data will be recorded:
age, gender, initial disease, age at diagnosis, additional diseases
duration and dosage of the bisphosphonate medication (kind of bisphosphonate, age at the beginning of the drug treatment, duration of treatment, frequency of intake, additional medications)
Clinical dental examination was performed for detection of; caries, gingival inflammation and oral hygiene, sequence of dental eruption, teeth extractions, and presence of exposure bone.
Unstimulated whole saliva was collected using the spitting method as previously described. Sialochemistry analysis will be performed.
Serum analysis findings including: calcium (Ca), phosphorous (P), alkaline phosphatase (AlP) and parathyroid hormone (PTH),vitamin D cross-linked telopeptides (ctx, ntx), bone density. (these examination are performed routinely, in these patients, as part of medical follow up.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Cavity, Osteomyelitis, Necrosis of the Jaws
Keywords
bisphosphonates, children, dental, Osteomyelitis, medication
7. Study Design
Enrollment
60 (Anticipated)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
children treated with bisphosphonate
Study Population Description
children treated with bisphosphonate who attend at the pediatric department of hadassah hospital and or to alyn hospital
Sampling Method
Non-Probability Sample
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
diana ram, DMD
Organizational Affiliation
lecturer, the Hebrew university, Hadassa school of dental medicine
Official's Role
Study Director
Facility Information:
Facility Name
Hadassah scool of Dental Medicine
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
12. IPD Sharing Statement
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The Influence of Bisphosphonates in the Oral Cavity in Children
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