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

Children's Hospital Los Angeles

Status: Enrolling

Conditions: Cleft Lip and Palate; Toothbrushing; Gingivitis

Treatments: Device: Toothbrush

Study type: Interventional

Funder types: Other

Identifiers

NCT06122805

CHLA-23-00184

Details and patient eligibility

About

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.

Full description

Pilot Study, Randomized Control Clinical Trial, study groups 1) Craniofacial and/or unilateral and bilateral cleft palate patients undergoing orthognathic surgery . 2) Craniofacial and/or unilateral and bilateral cleft palate patients undergoing bone-graft surgery 3) Craniofacial and/or unilateral and bilateral cleft palate patients with no pending surgery. Three Investigational device include Dual Light Therapy Sonic Toothbrush (BristlTM Toothbrush), Sonic Toothbrush(BRistlTM) and manual toothbrush to target disease gingivitis in 189 patients. Categorical variables scored from Plaque Index and Gingival Index will be analyzed using Fisher exact test and McNemar test. Parametric methods will be used to analyze data from Bleeding on Probing and Periodontal Probing Depth. To determine differences between groups and within each test at all time points, Student t-test will be used.

Enrollment: 198 estimated patients

Sex: All

Ages: 6 to 20 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• physical inability to brush teeth
• cognitive inability to comprehend and follow directions.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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198 participants in 9 patient groups

Orthognathic Surgery Manual Toothbrush

Experimental group

Description:

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.

Treatment:

Device: Toothbrush

Orthognathic Surgery Sonic toothbrush

Experimental group

Description:

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.

Treatment:

Device: Toothbrush

Orthognathic Surgery Sonic and dual light toothbrush

Experimental group

Description:

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

Treatment:

Device: Toothbrush

Bone Graft Manual Toothbrush

Experimental group

Description:

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.

Treatment:

Device: Toothbrush

Bone Graft Sonic Toothbrush

Experimental group

Description:

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.

Treatment:

Device: Toothbrush

Bone Graft Sonic and Dual-light Toothbrush

Experimental group

Description:

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

Treatment:

Device: Toothbrush

No surgery, Manual Toothbrush

Experimental group

Description:

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.

Treatment:

Device: Toothbrush

No Surgery, Sonic Toothbrush

Experimental group

Description:

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.

Treatment:

Device: Toothbrush

No Surgery, Sonic and Dual-light Toothbrush

Experimental group

Description:

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

Treatment:

Device: Toothbrush