Cleft LipNCT00975208
Osteogenesis and Dental Eruption Through Electrical Stimuli
An observational study of Cleft Lip, run by University of Guadalajara.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cleft Lip
- How many people
- 9 participants
- Where
- No sites listed yet
- Study dates
- Jan 2006to Aug 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients of the Institute of Reconstructive Surgery of Jalisco, México
Who may be able to join
- Patients with unilateral cleft lip and palate deformities and alveolar defects
Who cannot join
- 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)
About this study
Official title: Osteogenesis and Dental Eruption Through Electrical Stimuli Following Periosteoplasty for Alveolar Clefts in Patients With Cleft Lip and Palate Deformities. A Preliminary Report.
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.
- Conditions
- Cleft Lip
- Keywords
- Osteogenesis [G07.700.320.500.325.377.625.100.729], Tooth Eruption [G10.549.235.726]
- Medical subject headings
- Cleft Lip
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2009 (estimated)
- Study startJan 2006
- Primary completionNov 2007 (estimated)
- Study completionAug 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cleft LipStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Guadalajara
- Sponsor type
- University, hospital or other
- Investigators
- José Guerrerosantos, M.D., Ph.D., Study chair, Instituto Jalisciense de Cirugía Reconstructiva "Dr. Guerrerosantos"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00975208
- Sponsor's protocol ID
- CW1234
- Status last verified
- Sep 2009
- First submitted
- 10 Sep 2009
- Last updated
- 11 Sep 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Osteogenesis and Dental Eruption Through Electrical Stimuli Following Periosteoplasty for Alveolar Clefts in Patients With Cleft Lip and Palate Deformities. A Preliminary Report.
- ClinicalTrials.gov ID
- NCT00975208
- Acronym / sponsor ID
- CW1234
- Conditions
- Cleft Lip
- Keywords
- Osteogenesis [G07.700.320.500.325.377.625.100.729], Tooth Eruption [G10.549.235.726]
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of GuadalajaraUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Nov 2007 (estimated)
- Study completion
- Aug 2010 (estimated)
- First posted
- 11 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients of the Institute of Reconstructive Surgery of Jalisco, México
Key inclusion criteria (1 listed)
- Patients with unilateral cleft lip and palate deformities and alveolar defects
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
José Guerrerosantos, M.D., Ph.D. study chair
Instituto Jalisciense de Cirugía Reconstructiva "Dr. Guerrerosantos"
Questions about this trial
What is this clinical trial studying?
An observational study of Cleft Lip, run by University of Guadalajara.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2009.