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

NCT ID: NCT06122805

Last Updated: 2024-05-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 198 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-11
• Study Completion Date: 2027-11-30

Brief Summary

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.

Detailed 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.

Conditions

Toothbrushing; Gingivitis; Cleft Lip and Palate

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Toothbrush

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Toothbrush

Intervention Type: 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.

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

Group Type: EXPERIMENTAL

Toothbrush

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Toothbrush

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Toothbrush

Intervention Type: 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.

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

Group Type: EXPERIMENTAL

Toothbrush

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Toothbrush

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Toothbrush

Intervention Type: 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.

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

Group Type: EXPERIMENTAL

Toothbrush

Intervention Type: 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.

Interventions

Toothbrush

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Children's Hospital Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Stephen Yen

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stephen Yen, DMD, PhD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Los Angeles and USC

Locations

Chilldren's Hospital Los Angeles

Los Angeles, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Stephen Yen, DMD, PhD

Role: CONTACT

syen@chla.usc.edu

3233612130

Jose Polido, DDS

Role: CONTACT

jpolido@chla.usc.edu

3233612130

Facility Contacts

Stephen Yen

Role: primary

syen@chla.usc.edu

323-361-2130

Jose Polido

Role: backup

jpolido@chla.usc.edu

3233612130

References

Ccahuana-Vasquez RA, Conde E, Grender JM, Cunningham P, Qaqish J, Goyal CR. An Eight-Week Clinical Evaluation of an Oscillating-Rotating Power Toothbrush with a Brush Head Utilizing Angled Bristles Compared with a Sonic Toothbrush in the Reduction of Gingivitis and Plaque. J Clin Dent. 2015;26(3):80-5.

Reference Type: BACKGROUND

PMID: 26665291 (View on PubMed)

Other Identifiers

CHLA-23-00184

Identifier Type: -

Identifier Source: org_study_id