Effectiveness of Dual Light Electric Toothbrush vs. Manual Toothbrush in Orthodontic Patients Undergoing Oral Surgery

Part of paid clinical trials in Los Angeles, California.

Sponsor
Children's Hospital Los Angeles
Study ID
NCT06122805
Status
Recruiting
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Conditions

  • Cleft Lip and Palate
  • Gingivitis
  • Toothbrushing

Eligibility Criteria

Sex
ALL
Age
6 Years - 20 Years
Healthy Volunteers
Accepted

Interventions

  • Toothbrush — DEVICE
    We will test three toothbrushes in patients undergoing surgery and a control no surgery group. These toothbrushes are manual toothbrushes, sonic toothbrushes, and sonic and dual light toothbrushes.

Study Details

The study is a randomized clinical trial to compare the effectiveness of a dual light ultrasonic toothbrush on periodontal health in orthodontic patients undergoing surgery. Patients with cleft lip and palate undergo bone graft and orthognathic surgery. The study will compare the periodontal outcomes in patients who use these toothbrushes during the post-surgical period.

Key Dates

Start date
Mar 11, 2024
Status verified
May 2024
Primary completion
Nov 30, 2026
Completion
Nov 30, 2027

Study Design

Enrollment
198 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Orthognathic Surgery Manual Toothbrush
    1. Patient of record of the Craniofacial and Special Care Orthodontic Clinic at Children's Hospital Los Angeles 2. Between the ages of 6 and 20 years 3. Physical status of ASA I or II 4. Diagnosis of craniofacial and/or isolated, complete or incomplete, bilateral or unilateral cleft lip and palate 5. Intervention: Manual toothbrush.
  • Experimental: Orthognathic Surgery Sonic toothbrush
    1. Patient of record of the Craniofacial and Special Care Orthodontic Clinic at Children's Hospital Los Angeles 2. Between the ages of 6 and 20 years 3. Physical status of ASA I or II 4. Diagnosis of craniofacial and/or isolated, complete or incomplete, bilateral or unilateral cleft lip and palate 5. Intervention:Sonic toothbrush without activation of the dual light feature.
  • Experimental: Orthognathic Surgery Sonic and dual light toothbrush
    1. Patient of record of the Craniofacial and Special Care Orthodontic Clinic at Children's Hospital Los Angeles 2. Between the ages of 6 and 20 years 3. Physical status of ASA I or II 4. Diagnosis of craniofacial and/or isolated, complete or incomplete, bilateral or unilateral cleft lip and palate 5. Intervention:Sonic toothbrush with activation of the dual light feature
  • Experimental: Bone Graft Manual Toothbrush
    1. Patient of record of the Craniofacial and Special Care Orthodontic Clinic at Children's Hospital Los Angeles 2. Between the ages of 6 and 20 years 3. Physical status of ASA I or II 4. Diagnosis of craniofacial and/or isolated, complete or incomplete, bilateral or unilateral cleft lip and palate 5. Intervention:Manual toothbrush.
  • Experimental: Bone Graft Sonic Toothbrush
    1. Patient of record of the Craniofacial and Special Care Orthodontic Clinic at Children's Hospital Los Angeles 2. Between the ages of 6 and 20 years 3. Physical status of ASA I or II 4. Diagnosis of craniofacial and/or isolated, complete or incomplete, bilateral or unilateral cleft lip and palate 5. Intervention:Sonic toothbrush without activation of the dual light feature.
  • Experimental: Bone Graft Sonic and Dual-light Toothbrush
    1. Patient of record of the Craniofacial and Special Care Orthodontic Clinic at Children's Hospital Los Angeles 2. Between the ages of 6 and 20 years 3. Physical status of ASA I or II 4. Diagnosis of craniofacial and/or isolated, complete or incomplete, bilateral or unilateral cleft lip and palate 5. Intervention:Sonic toothbrush with activation of the dual light feature
  • Experimental: No surgery, Manual Toothbrush
    1. Patient of record of the Craniofacial and Special Care Orthodontic Clinic at Children's Hospital Los Angeles 2. Between the ages of 6 and 20 years 3. Physical status of ASA I or II 4. Diagnosis of craniofacial and/or isolated, complete or incomplete, bilateral or unilateral cleft lip and palate 5, Intervention:Manual toothbrush.
  • Experimental: No Surgery, Sonic Toothbrush
    1. Patient of record of the Craniofacial and Special Care Orthodontic Clinic at Children's Hospital Los Angeles 2. Between the ages of 6 and 20 years 3. Physical status of ASA I or II 4. Diagnosis of craniofacial and/or isolated, complete or incomplete, bilateral or unilateral cleft lip and palate 5. Intervention:Sonic toothbrush without activation of the dual light feature.
  • Experimental: No Surgery, Sonic and Dual-light Toothbrush
    1. Patient of record of the Craniofacial and Special Care Orthodontic Clinic at Children's Hospital Los Angeles 2. Between the ages of 6 and 20 years 3. Physical status of ASA I or II 4. Diagnosis of craniofacial and/or isolated, complete or incomplete, bilateral or unilateral cleft lip and palate 5. Intervention:Sonic toothbrush with activation of the dual light feature

Primary Outcome Measure

Löe and Silness Gingival Index [ Time Frame: 18 weeks, 6 weeks apart evaluations ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Chilldren's Hospital Los AngelesLos AngelesCalifornia90027
Stephen Yen
[email protected]
323-361-2130
Jose Polido
[email protected]
3233612130

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By research site
Chilldren's Hospital Los Angeles· Los Angeles, CA

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