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The Influence of Bisphosphonates in the Oral Cavity in Children

This study has been completed.
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00402064
First received: November 20, 2006
Last updated: January 28, 2009
Last verified: January 2009

November 20, 2006
January 28, 2009
March 2007
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Complete list of historical versions of study NCT00402064 on ClinicalTrials.gov Archive Site
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The Influence of Bisphosphonates in the Oral Cavity in Children
The Influence of Bisphosphonates in the Oral Cavity in Children

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

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:

  1. age, gender, initial disease, age at diagnosis, additional diseases
  2. 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)
  3. 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.
  4. Unstimulated whole saliva was collected using the spitting method as previously described. Sialochemistry analysis will be performed.
  5. 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.
Observational
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Non-Probability Sample

children treated with bisphosphonate who attend at the pediatric department of hadassah hospital and or to alyn hospital

  • Oral Cavity
  • Osteomyelitis
  • Necrosis of the Jaws
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
December 2008
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Inclusion Criteria:

  • children treated with bisphosphonate
Both
2 Years to 20 Years
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT00402064
st1975-HMO-CTIL
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Hadassah Medical Organization
Hadassah Medical Organization
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Study Director: diana ram, DMD lecturer, the Hebrew university, Hadassa school of dental medicine
Hadassah Medical Organization
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP