Electric Toothbrush for Post-Oral Surgery Care in Cleft Lip/Palate Patients

Overseen By Jose Polido, DDS

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital Los Angeles

Disqualifiers: Physical, cognitive inability, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 18 weeks

198 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a special electric toothbrush to determine its effectiveness in improving gum health after surgery in individuals with a cleft lip or palate. Researchers will divide participants into groups to use different types of toothbrushes, including a manual one and a dual light electric version (Dual Light Electric Toothbrush). The goal is to identify which toothbrush best aids healing after surgery. Ideal participants are children and young adults with a cleft lip or palate who are patients at a specific clinic in Los Angeles. As an unphased trial, this study allows participants to contribute to valuable research that could enhance post-surgical care for others with similar conditions.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this dual light ultrasonic toothbrush is safe for post-oral surgery care?

Research has shown that powered toothbrushes, such as the dual light electric toothbrush, are generally safe to use. Safety features, including designs that secure the bristles, prevent parts from detaching, ensuring these brushes are safe for daily use.

Specific data about side effects from the dual light feature is not available. However, electric toothbrushes are widely used and usually well-tolerated. They are designed to be gentle on gums and teeth, which is crucial for individuals who have recently undergone oral surgery.

Although detailed safety data for this particular toothbrush is lacking, similar products are typically safe and effective. Consulting a healthcare provider is advisable if there are concerns about using a new type of toothbrush after surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about this trial because it explores the effectiveness of electric toothbrushes, specifically those with dual light features, in enhancing oral care for cleft lip and palate patients post-surgery. Unlike traditional manual toothbrushes, which are standard for maintaining oral hygiene, these advanced electric toothbrushes provide sonic cleaning power, potentially improving plaque removal and gum health. The dual light feature is particularly intriguing as it might offer additional benefits such as antibacterial effects, offering a novel approach to post-surgical care and potentially speeding up recovery. By comparing various toothbrush types, this trial aims to identify the best method to support healing and oral health in this specific patient group.

What evidence suggests that this trial's treatments could be effective for post-oral surgery care in cleft lip/palate patients?

Research has shown that dual light ultrasonic toothbrushes can improve gum health, especially for people with braces. In this trial, participants will join different treatment arms to evaluate the effectiveness of various toothbrush types. Some participants will use a sonic toothbrush with the dual light feature, which uses sound vibrations and light therapy to potentially kill bacteria. Others will use a sonic toothbrush without the dual light feature or a manual toothbrush. While specific data for patients with cleft lip and palate is still being collected, the benefits observed in general orthodontic care suggest this technology could aid recovery after surgery and improve gum health. ^{1 2 4 6 7}

Who Is on the Research Team?

Stephen Yen, DMD, PhD

Principal Investigator

Children's Hospital Los Angeles and USC

Are You a Good Fit for This Trial?

This trial is for patients aged 6-20 with cleft lip and/or palate, who are undergoing bone graft or orthognathic surgery at the Children's Hospital Los Angeles. They should be in good physical health (ASA I or II).

Inclusion Criteria

I am between 6 and 20 years old.

My health is good or fairly good.

I have been diagnosed with a cleft lip and/or palate.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use either a dual light ultrasonic toothbrush, a sonic toothbrush, or a manual toothbrush to improve periodontal health post-surgery

18 weeks

Evaluations every 6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Dual Light Electric Toothbrush

Trial Overview The study tests a dual light ultrasonic toothbrush against a manual one to see which is better for gum health after oral surgery in orthodontic patients.

How Is the Trial Designed?

Group I: Orthognathic Surgery Sonic toothbrush Experimental Treatment 1 Intervention

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 II: Orthognathic Surgery Sonic and dual light toothbrush Experimental Treatment 1 Intervention

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 III: Orthognathic Surgery Manual Toothbrush Experimental Treatment 1 Intervention

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 IV: No surgery, Manual Toothbrush Experimental Treatment 1 Intervention

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 V: No Surgery, Sonic and Dual-light Toothbrush Experimental Treatment 1 Intervention

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 VI: No Surgery, Sonic Toothbrush Experimental Treatment 1 Intervention

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 VII: Bone Graft Sonic and Dual-light Toothbrush Experimental Treatment 1 Intervention

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 VIII: Bone Graft Sonic Toothbrush Experimental Treatment 1 Intervention

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 IX: Bone Graft Manual Toothbrush Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Children's Hospital Los Angeles

Lead Sponsor

Trials

257

Recruited

5,075,000+

Published Research Related to This Trial

In a clinical trial involving 80 adolescents with braces, there was no significant difference in plaque removal or reduction of gingival inflammation between electric 3D toothbrushes and manual toothbrushes over a 3-month period.

The study suggests that orthodontists should prioritize improving patients' overall dental hygiene practices rather than focusing solely on the type of toothbrush used, as both types were equally effective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized, 3-month, parallel-group clinical trial to compare the efficacy of electric 3-dimensional toothbrushes vs manual toothbrushes in maintaining oral health in patients with fixed orthodontic appliances. Mylonopoulou, IM., Pepelassi, E., Madianos, P., et al.[2022]

A systematic review of 35 studies found that oscillating-rotating power toothbrushes are as safe as manual toothbrushes, with no significant differences in gingival recession or adverse events reported.

The review indicates that oscillating-rotating toothbrushes do not pose a clinically relevant risk to hard or soft tissues, supporting their use as a safe alternative for dental hygiene.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of oscillating-rotating powered brushes compared to manual toothbrushes: a systematic review. Van der Weijden, FA., Campbell, SL., Dörfer, CE., et al.[2018]

In a study of 50 subjects with unilaterally treated complete cleft lip and palate, the periodontal health around abutment teeth was found to be poorer compared to nonabutment teeth, similar to trends seen in the general population.

The poorer periodontal condition around abutment teeth is likely due to the effects of prosthodontic treatment rather than the anatomical changes from the cleft itself, suggesting that dental interventions may impact long-term oral health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Periodontal condition in adult patients with unilateral complete cleft lip and palate. Ramstad, T.[2004]

A survey of 399 dentists in Germany revealed that 41% believe many patients do not clean their teeth properly, often due to poor technique or insufficient brushing time.

Most dentists (61%) recommend electric toothbrushes, particularly the Braun Oral-B Plaque Remover, with 73% observing improvements in tooth and gum health among patients who switched from manual to electric brushing, aligning with clinical studies that support the effectiveness of this electric toothbrush.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electric toothbrush use. Attitudes and experience among dental practitioners in Germany. Warren, PR., Landmann, H., Chater, BV.[2018]

In a study of 116 children with complete unilateral cleft lip and palate, the cleft-side lateral incisor was absent in 93.1% of cases, often due to agenesis or extraction, indicating a high prevalence of dental anomalies associated with this condition.

When the lateral incisor was missing, various treatment methods were employed, including orthodontic tooth movement (45%), surgical closure with alveolar bone grafting (35%), and prosthetic closure (17%), highlighting the need for tailored dental interventions in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of dental anomalies in children with complete unilateral cleft lip and palate at SickKids hospital, Toronto. Cassolato, SF., Ross, B., Daskalogiannakis, J., et al.[2022]

The study involved 6 patients with cleft lip and palate, and both types of double dentition denture treatments significantly improved masticatory efficiency and phonetics, with notable improvements observed immediately after treatment and one month later.

There was no significant difference in outcomes between the two denture designs, indicating that a palatal base is not necessary for defects smaller than 1 cm x 1 cm or in cases of submucous cleft palate.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Masticatory efficiency and phonetics effects of double dentition denture for cleft lip and palate patients with different base design]. Xing, GF., Sun, J., Chen, Y., et al.[2018]

In a study of 104 participants over 4 weeks, all three toothbrushes (Crest Spin Brush, Colgate ActiBrush, and Oral B 40) were found to be generally safe, with only mild adverse events reported, primarily localized gingivitis.

The Crest Spin Brush and Colgate ActiBrush were better tolerated than the Oral B 40, suggesting that electric toothbrushes can be as safe as manual ones for daily use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of three toothbrushes. He, T., Carpinello, L., Baker, R., et al.[2007]

In a 3-month study involving 110 healthy participants, the Braun Oral-B D17 power toothbrush demonstrated greater efficacy in reducing plaque and gingivitis compared to a manual toothbrush, with significant improvements observed at both 1 and 3 months.

The D17 toothbrush was found to be safe, with no product-related adverse effects reported and no clinically significant tissue abrasion noted, indicating it is a reliable option for oral hygiene.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety, efficacy and acceptability of a new power toothbrush: a 3-month comparative clinical investigation. Warren, PR., Cugini, M., Marks, P., et al.[2006]

In a study of 100 children with unilateral and bilateral cleft lip and palate, poor oral hygiene was prevalent, with 57% of participants showing inadequate oral care, but significant differences were noted between countries: 60% of German patients had optimal oral hygiene compared to only 19% in Poland.

Despite higher plaque levels in Polish patients, healthy periodontal conditions were more common in Germany, suggesting that factors beyond oral hygiene, such as genetics or treatment approaches, may play a crucial role in periodontal health in children with cleft conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Periodontal status and oral hygiene in two populations of cleft patients. Stec, M., Szczepańska, J., Pypeć, J., et al.[2022]

Parents of children with cleft lip and/or palate (CL/P) are highly motivated to ensure their children's oral health, but the children's motivation to brush their teeth regularly is often inconsistent.

The study identified several obstacles that hinder regular tooth brushing, including challenges related to the CL/P condition, forgetfulness, and childhood illnesses, indicating a need for additional support for parents to help maintain consistent oral hygiene practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experience of maintaining tooth brushing for children born with a cleft lip and/or palate. Lin, YL., Davies, K., Callery, P.[2021]

Guided bone regeneration using autologous bone grafting is the most effective method for closing oronasal communication in patients with cleft lip and palate (CLP).

In an 18-year-old patient with right unilateral CLP, a titanium implant was successfully used to replace a missing lateral incisor, demonstrating that implant-prosthetic rehabilitation can effectively restore dental function and aesthetics without sacrificing adjacent teeth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implant-prosthetic rehabilitation for a patient with monolateral cleft lip and palate: a clinical report. Vecchiatini, R., Mobilio, N., Raimondi, F., et al.[2021]

The treatment of an adult patient with bilateral cleft lip and palate involved the use of 5 dental implants and a monolithic zirconia complete-arch fixed prosthesis, which provided stability and support for the mobile premaxillary segment.

The zirconia prosthesis not only splinted the implants but also helped stabilize the premaxillary segment, addressing the unique challenges posed by the patient's condition, including oral-nasal communication and soft tissue issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Full arch monolithic zirconia prosthesis in a patient with bilateral cleft palate: A clinical report. Stangler, M., Bidra, AS.[2021]

Citations

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Effectiveness of Dual Light Electric Toothbrush vs. Manual ... The study is a randomized clinical trial to compare the effectiveness of a dual light ultrasonic toothbrush on periodontal health in orthodontic patients ...

2. ctv.veeva.com ctv.veeva.com/study/effectiveness-of-dual-light-electric-toothbrush-vs-manual-toothbrush-in-orthodontic-patients-underg

Effectiveness of Dual Light Electric Toothbrush vs. Manual ... The study is a randomized clinical trial to compare the effectiveness of a dual light ultrasonic toothbrush on periodontal health in ...

3. clinicaltrial.be clinicaltrial.be/en/details/286951?per_page=20&only_recruiting=0&only_eligible=0&only_active=0

Effectiveness of Dual Light Electric Toothbrush vs. Manua... We will test three toothbrushes in patients undergoing surgery and a control no surgery group. These toothbrushes are manual toothbrushes, sonic ...

4. withpower.com withpower.com/trial/phase-cleft-lip-10-2023-287f1

Electric Toothbrush for Post-Oral Surgery Care in Cleft Lip/ ... The study is a randomized clinical trial to compare the effectiveness of a dual light ultrasonic toothbrush on periodontal health in orthodontic patients ...

5. researchgate.net researchgate.net/publication/347651839_Accidental_Oral_Injuries_by_Electric_Toothbrush_A_Report_of_Three_Cases

Accidental Oral Injuries by Electric Toothbrush: A Report of ... Electric toothbrushes can cause oral penetrating injuries and infections in the same manner as manual toothbrushes. Prevention of oral trauma ...

6. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06122805/effectiveness-of-dual-light-electric-toothbrush-vs-manual-toothbrush-in-orthodontic-patients-undergoing-oral-surgery?id=593&slug=Periodontitis

Effectiveness of Dual Light Electric Toothbrush vs. Manual ... The study will compare the periodontal outcomes in patients who use these toothbrushes during the post-surgical period. Eligibility Criteria ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7148448/

Safety and Design Aspects of Powered Toothbrush—A ... To conclude, tuft retention design is important in the powered toothbrush as it contributes significantly to safety as the fallen off tufts, filaments and metal ...