NCT00975208

Brief Summary

The closure of the alveolar cleft as part of cleft lip and palate deformities is a procedure that, to this date, still demands great efforts from plastic surgeons. The feasibility of periosteoplasty for reconstruction of the alveolar arcade as well as the use of electrical stimulation in order to increase osteoneogenesis have been proven in the past. The present study attempts to combine both procedures that have only been reported separately worldwide. The objective of this study is to increase the osteogenic capacity and hence, dental eruption.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
9

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2006

Longer than P75 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

September 10, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 11, 2009

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

September 11, 2009

Status Verified

September 1, 2009

Enrollment Period

1.8 years

First QC Date

September 10, 2009

Last Update Submit

September 10, 2009

Conditions

Cleft Lip

Keywords

Osteogenesis [G07.700.320.500.325.377.625.100.729]Tooth Eruption [G10.549.235.726]

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients of the Institute of Reconstructive Surgery of Jalisco, México

You may qualify if:

  • Patients with unilateral cleft lip and palate deformities and alveolar defects

You may not qualify if:

  • Patients without alveolar cleft
  • Patients with syndromes that did not require periosteoplastic procedures as well as patients with systemic illnesses that may affect the result of the study (for instance diabetes)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cleft Lip

Condition Hierarchy (Ancestors)

Lip DiseasesMouth DiseasesStomatognathic DiseasesMouth AbnormalitiesStomatognathic System AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • José Guerrerosantos, M.D., Ph.D.

    Instituto Jalisciense de Cirugía Reconstructiva "Dr. Guerrerosantos"

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 10, 2009

First Posted

September 11, 2009

Study Start

January 1, 2006

Primary Completion

November 1, 2007

Study Completion

August 1, 2010

Last Updated

September 11, 2009

Record last verified: 2009-09