ToothbrushingNCT06122805
Effectiveness of Dual Light Electric Toothbrush vs. Manual Toothbrush in Orthodontic Patients Undergoing Oral Surgery
A study testing Toothbrush in people with Toothbrushing and Gingivitis, run by Children's Hospital Los Angeles at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Toothbrushing, Gingivitis, Cleft Lip and Palate
- What is being tested?
- Toothbrush
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Mar 2024to 30 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- physical inability to brush teeth
- cognitive inability to comprehend and follow directions.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Chilldren's Hospital Los Angeles
Los Angeles, California, 90027
Stephen Yen, 323-361-2130, syen@chla.usc.edu
Jose Polido, 3233612130, jpolido@chla.usc.edu
About this study
Official title: Effectiveness of Dual Light Therapy Electric Toothbrush vs.Manual Toothbrush on Periodontal Health of Orthodontic Patients Undergoing Oral Surgery
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.
Read the 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
- Being tested
- Toothbrush
- Medical subject headings
- Gingivitis, Cleft Lip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ToothbrushDevice
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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 Receives: 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. Receives: 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. Receives: 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 Receives: 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. Receives: 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. Receives: 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 Receives: Device: Toothbrush |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 18 weeks, 6 weeks apart evaluations
Secondary outcomes (1)
Turesky et al Modified Quigley-Hein Plaque Index and Modified Plaque Index for Orthodontic Patient
After placement of five drops of Trace® plaque disclosing liquid under the tongue, the participant will swish the solution for 30 seconds. Upon expectoration, the participant will rinse his/her mouth with water three times. Immediately, intraoral photographs will be made. All photos for Gingival Index and Plaque Index will be scored by two blinded scorers with inter-rater reliability calculated. All scoring data will be assessed by statistician.
Measured: 18 weeks, 6 week apart evaluations
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2023
- Study start11 Mar 2024
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ToothbrushingStudies of the same condition, open and under way.
- More trials run by Children's Hospital Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 198 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephen Yen, Children's Hospital Los Angeles
- Investigators
- Stephen Yen, DMD, PhD, Principal investigator, Children's Hospital Los Angeles and USC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06122805
- Sponsor's protocol ID
- CHLA-23-00184
- Status last verified
- May 2024
- First submitted
- 3 Nov 2023
- Last updated
- 13 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 26665291
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Dual Light Therapy Electric Toothbrush vs.Manual Toothbrush on Periodontal Health of Orthodontic Patients Undergoing Oral Surgery
- ClinicalTrials.gov ID
- NCT06122805
- Acronym / sponsor ID
- CHLA-23-00184
- Conditions
- Toothbrushing, Gingivitis, Cleft Lip and Palate
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 198 participants (estimated)
- Lead sponsor
- Children's Hospital Los AngelesUniversity, hospital or other
- Study start
- 11 Mar 2024 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 8 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 9
- Model description
- Randomized
| Arm | Type | Receives |
|---|---|---|
| Orthognathic Surgery Manual Toothbrush | Experimental | Device: Toothbrush1. 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. |
| Orthognathic Surgery Sonic toothbrush | Experimental | Device: Toothbrush1. 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. |
| Orthognathic Surgery Sonic and dual light toothbrush | Experimental | Device: Toothbrush1. 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 |
| Bone Graft Manual Toothbrush | Experimental | Device: Toothbrush1. 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. |
| Bone Graft Sonic Toothbrush | Experimental | Device: Toothbrush1. 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. |
| Bone Graft Sonic and Dual-light Toothbrush | Experimental | Device: Toothbrush1. 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 |
| No surgery, Manual Toothbrush | Experimental | Device: Toothbrush1. 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. |
| No Surgery, Sonic Toothbrush | Experimental | Device: Toothbrush1. 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. |
| No Surgery, Sonic and Dual-light Toothbrush | Experimental | Device: Toothbrush1. 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 |
Who may qualify
- Ages
- 6 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- physical inability to brush teeth
- cognitive inability to comprehend and follow directions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ToothbrushWe 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. | Device | 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 |
Primary outcome
Löe and Silness Gingival Index
Time frame: 18 weeks, 6 weeks apart evaluations
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.
Bleeding index
Time frame: 18 weeks, 6 weeks apart evaluations
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
1 secondary outcome
Turesky et al Modified Quigley-Hein Plaque Index and Modified Plaque Index for Orthodontic Patient
Time frame: 18 weeks, 6 week apart evaluations
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2024.
- Background: PubMed 26665291Ccahuana-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stephen Yen, DMD, PhD principal investigator
Children's Hospital Los Angeles and USC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Toothbrush in people with Toothbrushing and Gingivitis, run by Children's Hospital Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephen Yen, DMD, PhD (3233612130, syen@chla.usc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Löe and Silness Gingival Index (time frame: 18 weeks, 6 weeks apart evaluations). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06122805, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2024.