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

NCT06122805 | Recruiting FDA Device

• 1 other identifier: CHLA-23-00184
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 1

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.

Conditions

Toothbrushing; Gingivitis; Cleft Lip and Palate

Outcome Measures

Primary Outcomes (2)

• Löe and Silness Gingival Index

  This involves a two-step process: Step One (1): evaluation of the clinical appearance of the gingival tissue; and Step Two (2): assessment of inflammation based on induction of bleeding from probing11. Step One will not be accomplished chairside but will be measured using photographs; Step Two will be done chairside.

  18 weeks, 6 weeks apart evaluations

• Bleeding index

  For Bleeding Index (Appendix IIC) and measurement of Probing Depth, the scorers will be calibrated following the Examiner Guide to Measuring Periodontal Parameters \& Indices11. Probing Depth will be measured using a University of North Carolina (UNC) #15 manual probe and a #5 mouth mirror

  18 weeks, 6 weeks apart evaluations

Secondary Outcomes (1)

• Turesky et al Modified Quigley-Hein Plaque Index and Modified Plaque Index for Orthodontic Patient

  18 weeks, 6 week apart evaluations

Study Arms (9)

Orthognathic Surgery Manual Toothbrush

EXPERIMENTAL

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.

Device: Toothbrush

Orthognathic Surgery Sonic toothbrush

EXPERIMENTAL

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.

Device: Toothbrush

Orthognathic Surgery Sonic and dual light toothbrush

EXPERIMENTAL

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

Device: Toothbrush

Bone Graft Manual Toothbrush

EXPERIMENTAL

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.

Device: Toothbrush

Bone Graft Sonic Toothbrush

EXPERIMENTAL

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.

Device: Toothbrush

Bone Graft Sonic and Dual-light Toothbrush

EXPERIMENTAL

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

Device: Toothbrush

No surgery, Manual Toothbrush

EXPERIMENTAL

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.

Device: Toothbrush

No Surgery, Sonic Toothbrush

EXPERIMENTAL

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.

Device: Toothbrush

No Surgery, Sonic and Dual-light Toothbrush

EXPERIMENTAL

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

Device: Toothbrush

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.

Bone Graft Manual Toothbrush; Bone Graft Sonic Toothbrush; Bone Graft Sonic and Dual-light Toothbrush; No Surgery, Sonic Toothbrush; No Surgery, Sonic and Dual-light Toothbrush; No surgery, Manual Toothbrush; Orthognathic Surgery Manual Toothbrush; Orthognathic Surgery Sonic and dual light toothbrush; Orthognathic Surgery Sonic toothbrush

Eligibility Criteria

• Age: 6 Years - 20 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Children's Hospital Los Angeles: lead

Study Sites (1)

Chilldren's Hospital Los Angeles

Los Angeles, California, 90027, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 26665291 BACKGROUND

MeSH Terms

Conditions

Gingivitis; Cleft Lip

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Lip Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Stephen Yen, DMD, PhD

  Children's Hospital Los Angeles and USC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephen Yen, DMD, PhD

CONTACT

3233612130; syen@chla.usc.edu

Jose Polido, DDS

CONTACT

3233612130; jpolido@chla.usc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: randomized assignment of study ID number
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Randomized

Study Record Dates

• First Submitted: November 3, 2023
• First Posted: November 8, 2023
• Study Start: March 11, 2024
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2027
• Last Updated: May 13, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)