Visual Aids for Cleft Lip Surgery

Not currently recruiting at 1 trial location

Overseen By Carroll Ann Trotman

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Tufts University

Disqualifiers: Craniofacial anomaly, Collagen vascular, Neurologic, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how surgeons can use pictures and videos to improve surgeries for cleft lips, which are gaps or splits in the upper lip that can occur before birth. The goal is to determine if these visual aids (static images and facial videos) help surgeons make better decisions when fixing or revising a cleft lip. Suitable participants for this trial include those who have already had their cleft lip repaired and need another surgery, or those with a cleft lip that hasn't been fixed yet. As an unphased trial, this study offers participants a unique opportunity to contribute to innovative surgical techniques that could enhance future cleft lip repairs.

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 these visual aids are safe for use in cleft lip surgery?

Research has shown that using pictures and videos of faces in cleft lip surgery is safe for participants. These include 2D and 3D images and videos taken before surgery. No known side effects result from using these visual aids, as they serve only to help surgeons plan surgeries more effectively.

These aids do not involve drugs or invasive procedures, eliminating the risk of physical harm. The focus remains on aiding surgeons in decision-making, which does not directly impact patient safety. Participants can feel assured that these visual aids are safe and well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using visual aids like static images and facial videos for cleft lip surgery because these tools offer a unique approach to pre-surgical planning. Unlike traditional methods that rely heavily on a surgeon's experience and standard photos, these visual aids provide detailed 2D and 3D imagery that helps in accurately assessing the patient's facial structure. This enhanced visualization can lead to more precise surgical outcomes and personalized treatment plans, potentially improving both aesthetic and functional results for patients. By offering a more comprehensive view of facial anatomy, these visual aids could revolutionize how surgeons prepare for and execute cleft lip surgeries.

What evidence suggests that these visual aids are effective for cleft lip surgery?

Research has shown that pictures and videos of faces can help surgeons make better decisions during cleft lip surgeries. In this trial, participants will be evaluated using static images and facial videos. One study found that these visual tools help assess lip symmetry, which is crucial for better surgical outcomes. Another study discovered that 2D and 3D images provide surgeons with detailed visual information, enhancing surgical accuracy. These findings suggest that visual aids might improve the precision and success of cleft lip surgeries. ^{2 4 6 7 8}

Who Is on the Research Team?

Carroll Ann Trotman

Principal Investigator

Tufts University School of Dental Medicine

Are You a Good Fit for This Trial?

This trial is for individuals aged 4 to 21 with a previously repaired unilateral or bilateral cleft lip and palate, including a complete cleft of the primary palate and at least a partial cleft of the secondary palate. Candidates must be recommended for lip revision surgery by their craniofacial plastic surgeon.

Inclusion Criteria

I am between 4 and 21 years old.

I had surgery to repair a cleft lip and palate.

My surgeon recommends a lip revision surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Surgeons use the SAFS Intervention to assess and plan treatment for lip revision and primary lip repair surgeries

2 years

Follow-up

Participants are monitored for surgical outcomes and adverse events

2 years

What Are the Treatments Tested in This Trial?

Interventions

• Static Images and Facial Videos

Trial Overview The study aims to understand how surgeons use visual aids like static images and facial videos alongside objective measures in decision-making for cleft lip surgery. It involves comparing different approaches using patient cohorts undergoing lip repair or revision surgeries.

How Is the Trial Designed?

Group I: Static Images and Facial Videos Experimental Treatment 1 Intervention

2D and 3D still and video images obtained from each patient before surgery.

Who Is Running the Clinical Trial?

Tufts University

Lead Sponsor

Trials

271

Recruited

595,000+

Massachusetts General Hospital

Collaborator

Trials

3,066

Recruited

13,430,000+

Wake Forest University Health Sciences

Collaborator

Trials

1,432

Recruited

2,506,000+

Boston Children's Hospital

Collaborator

Trials

801

Recruited

5,584,000+

Tufts Medical Center

Collaborator

Trials

264

Recruited

264,000+

University of Bath

Collaborator

Trials

104

Recruited

16,400+

University of North Carolina, Chapel Hill

Collaborator

Trials

1,588

Recruited

4,364,000+

Published Research Related to This Trial

A risk map was developed in the Oral and Maxillofacial Surgery Service at the University Hospital 'Virgen de las Nieves' to identify and minimize adverse effects (AEs), with 33 AEs identified during the study period from June 2017 to May 2018.

The study found that the Surgical Area had a higher incidence of AEs (22) compared to Outpatient Clinic and Hospital Discharge areas (6), highlighting the need for targeted safety measures in surgical practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Development of a risk map in an oral and maxillofacial surgical unit]. Sánchez López, JD., Cambil Martín, J., Villegas Calvo, M., et al.[2020]

Out of 409,991 patients who underwent soft tissue reconstructive procedures from 2005 to 2010, 4.06% experienced adverse events (AEs), indicating that while AEs are not uncommon, the overall rates are lower compared to other surgical disciplines.

Certain patient characteristics, such as older age, male gender, nonwhite ethnicity, and reliance on public insurance, were associated with higher rates of AEs, highlighting the need for targeted quality improvement efforts in these populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient safety in plastic surgery: identifying areas for quality improvement efforts. Hernandez-Boussard, T., McDonald, KM., Rhoads, KF., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11909766/

Deep Learning-Based Assessment of Lip Symmetry for ... We propose an automated approach for assessing lip asymmetry in patients with repaired cleft lip by transforming facial images of control subjects.

2. withpower.com withpower.com/trial/phase-cleft-lip-2018-d4e43

Visual Aids for Cleft Lip Surgery Trial Overview The study aims to understand how surgeons use visual aids like static images and facial videos alongside objective measures in decision-making ...

3. link.springer.com link.springer.com/article/10.1007/s11548-025-03396-z

Evaluation of synthetic training data for 3D intraoral ... This study investigates the effectiveness of synthetic training data in predicting 2D landmarks for 3D intraoral reconstruction in cleft lip and palate ...

4. journals.lww.com journals.lww.com/prsgo/fulltext/2025/04000/a_summary_of_the_existing_data_on_cleft_surgical.13.aspx

A Summary of the Existing Data on Cleft Surgical ... This article presents a summary of the current state of the literature on surgical outcomes following CLP repair.

5. auctoresonline.org auctoresonline.org/article/decision-considerations-and-strategies-for-lip-surgery-in--patients-with-cleft-lippalate-a-qualitative-study

Decision Considerations and Strategies for Lip Surgery in ... The surgeon participants (n=8) were experienced in cleft care. Facial imaging data that included 2D images, 3D images, videos, and objective 3D visual modelling ...

6. medrxiv.org medrxiv.org/content/10.1101/2023.04.20.23287416v1.full-text

Decision Considerations and Strategies for Lip Surgery in ... Facial imaging data that included 2D images, 3D images, videos, and objective 3D visual modelling of facial movements were collected from each patient, and ...

7. researchgate.net researchgate.net/publication/387702265_Social_Media_Depiction_of_Cleft_Lip_and_Cleft_Palate_Instagram_Versus_YouTube_Shorts_Analysis_Instagram_Post_Versus_Instagram_Reel_Analysis

(PDF) Social Media Depiction of Cleft Lip and Cleft Palate In this study, we investigated Instagram and YouTube Shorts posts related to cleft lip · results. · with cleft lip and palate. · This qualitative ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11197461/

Decision Considerations and Strategies for Lip Surgery in ... Facial imaging data that included 2D images, 3D images, videos, and objective 3D visual modelling of facial movements were collected from each patient, and ...