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

Trial Summary

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 data supports the effectiveness of the treatment Dual Light Electric Toothbrush for post-oral surgery care in cleft lip/palate patients?

The research highlights that children with cleft lip and/or palate often have poorer oral health, making effective tooth brushing crucial. While the studies don't directly address the Dual Light Electric Toothbrush, maintaining good oral hygiene is important for these patients, suggesting that an advanced toothbrush could potentially help improve their oral health. ^{1 2 3 4 5}

Is the electric toothbrush safe for use in humans?

The safety of electric toothbrushes, including oscillating-rotating types, has been studied and they are generally considered safe for oral tissues when compared to manual toothbrushes. ^{6 7 8 9 10}

How does the electric toothbrush treatment differ from other treatments for cleft lip/palate patients?

The use of an electric toothbrush for post-oral surgery care in cleft lip/palate patients is unique because it focuses on improving oral hygiene, which is often challenging for these patients. Unlike other treatments that may involve surgical or prosthetic interventions, this approach emphasizes maintaining oral health through effective tooth brushing, which is crucial for preventing dental issues in this population. ^{1 2 4 11 12}

What is the purpose of this trial?

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.

Research Team

Stephen Yen, DMD, PhD

Principal Investigator

Children's Hospital Los Angeles and USC

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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 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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Treatment of dental anomalies in children with complete unilateral cleft lip and palate at SickKids hospital, Toronto. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Periodontal status and oral hygiene in two populations of cleft patients. [2022]

3. China pubmed.ncbi.nlm.nih.gov

[Masticatory efficiency and phonetics effects of double dentition denture for cleft lip and palate patients with different base design]. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Experience of maintaining tooth brushing for children born with a cleft lip and/or palate. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

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

6. United States pubmed.ncbi.nlm.nih.gov

Safety of three toothbrushes. [2007]

7. United States pubmed.ncbi.nlm.nih.gov

Electric toothbrush use. Attitudes and experience among dental practitioners in Germany. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Safety, efficacy and acceptability of a new power toothbrush: a 3-month comparative clinical investigation. [2006]

9. United States 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. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Safety of oscillating-rotating powered brushes compared to manual toothbrushes: a systematic review. [2018]

11. Germany pubmed.ncbi.nlm.nih.gov

Implant-prosthetic rehabilitation for a patient with monolateral cleft lip and palate: a clinical report. [2021]

12. United States pubmed.ncbi.nlm.nih.gov

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