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Electric Toothbrush for Post-Oral Surgery Care in Cleft Lip/Palate Patients

N/A
Waitlist Available
Research Sponsored by Children's Hospital Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Between the ages of 6 and 20 years
Physical status of ASA I or II
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 weeks, 6 week apart evaluations
Awards & highlights

Study Summary

This trial will compare the effects of a special toothbrush on the periodontal health of people who have had cleft lip or palate surgery.

Who is the study for?
This trial is for patients aged 6-20 with cleft lip and/or palate, who are undergoing bone graft or orthognathic surgery at the Children's Hospital Los Angeles. They should be in good physical health (ASA I or II).Check my eligibility
What is being tested?
The study tests a dual light ultrasonic toothbrush against a manual one to see which is better for gum health after oral surgery in orthodontic patients.See study design
What are the potential side effects?
There may not be significant side effects from using an electric toothbrush compared to a manual one; however, some individuals might experience discomfort or irritation depending on their sensitivity post-surgery.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 6 and 20 years old.
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My health is good or fairly good.
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I have been diagnosed with a cleft lip and/or palate.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 weeks, 6 week apart evaluations
This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 weeks, 6 week apart evaluations for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Bleeding index
Löe and Silness Gingival Index
Secondary outcome measures
Turesky et al Modified Quigley-Hein Plaque Index and Modified Plaque Index for Orthodontic Patient

Trial Design

9Treatment groups
Experimental Treatment
Group I: Orthognathic Surgery Sonic toothbrushExperimental Treatment1 Intervention
Patient of record of the Craniofacial and Special Care Orthodontic Clinic at Children's Hospital Los Angeles Between the ages of 6 and 20 years Physical status of ASA I or II Diagnosis of craniofacial and/or isolated, complete or incomplete, bilateral or unilateral cleft lip and palate Intervention:Sonic toothbrush without activation of the dual light feature.
Group II: Orthognathic Surgery Sonic and dual light toothbrushExperimental Treatment1 Intervention
Patient of record of the Craniofacial and Special Care Orthodontic Clinic at Children's Hospital Los Angeles Between the ages of 6 and 20 years Physical status of ASA I or II Diagnosis of craniofacial and/or isolated, complete or incomplete, bilateral or unilateral cleft lip and palate Intervention:Sonic toothbrush with activation of the dual light feature
Group III: Orthognathic Surgery Manual ToothbrushExperimental Treatment1 Intervention
Patient of record of the Craniofacial and Special Care Orthodontic Clinic at Children's Hospital Los Angeles Between the ages of 6 and 20 years Physical status of ASA I or II Diagnosis of craniofacial and/or isolated, complete or incomplete, bilateral or unilateral cleft lip and palate Intervention: Manual toothbrush.
Group IV: No surgery, Manual ToothbrushExperimental Treatment1 Intervention
Patient of record of the Craniofacial and Special Care Orthodontic Clinic at Children's Hospital Los Angeles Between the ages of 6 and 20 years Physical status of ASA I or II Diagnosis of craniofacial and/or isolated, complete or incomplete, bilateral or unilateral cleft lip and palate 5, Intervention:Manual toothbrush.
Group V: No Surgery, Sonic and Dual-light ToothbrushExperimental Treatment1 Intervention
Patient of record of the Craniofacial and Special Care Orthodontic Clinic at Children's Hospital Los Angeles Between the ages of 6 and 20 years Physical status of ASA I or II Diagnosis of craniofacial and/or isolated, complete or incomplete, bilateral or unilateral cleft lip and palate Intervention:Sonic toothbrush with activation of the dual light feature
Group VI: No Surgery, Sonic ToothbrushExperimental Treatment1 Intervention
Patient of record of the Craniofacial and Special Care Orthodontic Clinic at Children's Hospital Los Angeles Between the ages of 6 and 20 years Physical status of ASA I or II Diagnosis of craniofacial and/or isolated, complete or incomplete, bilateral or unilateral cleft lip and palate Intervention:Sonic toothbrush without activation of the dual light feature.
Group VII: Bone Graft Sonic and Dual-light ToothbrushExperimental Treatment1 Intervention
Patient of record of the Craniofacial and Special Care Orthodontic Clinic at Children's Hospital Los Angeles Between the ages of 6 and 20 years Physical status of ASA I or II Diagnosis of craniofacial and/or isolated, complete or incomplete, bilateral or unilateral cleft lip and palate Intervention:Sonic toothbrush with activation of the dual light feature
Group VIII: Bone Graft Sonic ToothbrushExperimental Treatment1 Intervention
Patient of record of the Craniofacial and Special Care Orthodontic Clinic at Children's Hospital Los Angeles Between the ages of 6 and 20 years Physical status of ASA I or II Diagnosis of craniofacial and/or isolated, complete or incomplete, bilateral or unilateral cleft lip and palate Intervention:Sonic toothbrush without activation of the dual light feature.
Group IX: Bone Graft Manual ToothbrushExperimental Treatment1 Intervention
Patient of record of the Craniofacial and Special Care Orthodontic Clinic at Children's Hospital Los Angeles Between the ages of 6 and 20 years Physical status of ASA I or II Diagnosis of craniofacial and/or isolated, complete or incomplete, bilateral or unilateral cleft lip and palate Intervention:Manual toothbrush.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Toothbrush
2011
Completed Phase 4
~70

Find a Location

Who is running the clinical trial?

Children's Hospital Los AngelesLead Sponsor
232 Previous Clinical Trials
5,076,326 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any opportunities for individuals to participate in this experiment currently?

"According to the latest update on clinicaltrials.gov, this research is not presently recruiting patients. The trial was first listed on November 30th 2023 and its data was last updated 3 days ago; however, 45 other studies are actively enrolling participants at the moment."

Answered by AI

Does the trial population encompass persons aged 75 or above?

"According to the rules of this medical trial, individuals between the age of 6 and 20 are eligible for enrolment."

Answered by AI

Are there any openings for me to join this clinical experiment?

"Patients that wish to enrol in this trial must be aged between 6 and 20 years old, as well as practice regular toothbrushing. The researchers are hoping to acquire around 198 participants for the study."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Effectiveness of Dual Light Electric Toothbrush vs. Manual Toothbrush in Orthodontic Patients Undergoing Oral Surgery
Stephen Yen 2023. "Effectiveness of Dual Light Electric Toothbrush vs. Manual Toothbrush in Orthodontic Patients Undergoing Oral Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06122805.
~132 spots leftby Nov 2025
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