- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07379671
The Effect of the Mamelon Effect on the Perception of Smile Esthetics (MamelonEffect)
The Effect of the Mamelon Effect on Upper Incisors on the Perception of Smile Esthetics
Study Overview
Status
Intervention / Treatment
Detailed Description
This observational, cross-sectional study was designed to investigate the effect of incisal mamelon characteristics on the perception of smile esthetics using digitally modified facial images. The study protocol was approved by the Marmara University Faculty of Medicine Ethics Committee and was conducted in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines. Written informed consent was obtained from the volunteer whose facial photographs were used, as well as from all survey participants.
Study Design and Image Preparation A single volunteer meeting the inclusion criteria (aged 18-65 years; clinically healthy maxillary anterior teeth; proportional tooth dimensions; no restorations, orthodontic anomalies, or pronounced mamelon appearance) was selected. Extraoral smile photographs were captured using a digital single-lens reflex (DSLR) camera under standardized lighting conditions. Both full-face smile and close-up smile images were obtained to reflect different viewing distances relevant to daily social interactions and clinical evaluations.
The original digital image was transferred to a computer environment and edited using image-processing software (Adobe Photoshop CC, Adobe Systems, USA). Digital modifications were limited to the maxillary incisors (central and lateral teeth) while preserving facial symmetry, dental midline, gingival contours, and surrounding oral tissues.
Two main variables were manipulated:
Mamelon length (cervico-incisal extension): 1 mm and 3 mm Mamelon value (brightness level): low value (LV) and high value (HV) Mamelon effects were applied either to the maxillary central incisors alone (2 teeth) or to both central and lateral incisors simultaneously (4 teeth). Using these parameters, digitally modified images were created to simulate different mamelon configurations while maintaining natural tooth anatomy and proportions.
Study Groups and Image Sets
A total of 16 modified images were generated from the original photograph, consisting of:
8 full-face smile images 8 close-up smile images Together with the original unmodified full-face and close-up images, a total of 18 images were included in the evaluation set. All images were randomized prior to assessment to minimize ordering and learning effects.
Participants and Survey Procedure
A total of 135 participants were recruited and equally distributed into three observer groups:
Dentists (n = 45) Dental specialists (restorative dentistry and prosthodontics) (n = 45) Laypersons with no dental education (n = 45) Participants completed an anonymous online survey. Demographic information including age, gender, and professional background was recorded. Each participant evaluated all 18 images using a visual analog scale (VAS) ranging from 0 to 100, where higher scores indicated greater perceived smile attractiveness.
Outcome Measures
The primary outcome measure was the perceived smile esthetic score assigned to each image. Secondary analyses examined the influence of:
Image type (full-face vs. close-up) Mamelon length Mamelon value Number of teeth involved (2 vs. 4 incisors) Observer group (dentists, specialists, laypersons) Gender of the observers Statistical Analysis Statistical analysis was performed using appropriate statistical software. Descriptive statistics were calculated as mean ± standard deviation. Pairwise comparisons between groups and image conditions were conducted using Bonferroni-adjusted post hoc tests. The level of statistical significance was set at p < 0.05.
Ethical Considerations All photographic materials were obtained following written informed consent, including explicit permission for digital modification and scientific use of the images. Survey participation was voluntary and anonymous. No financial compensation was provided. The study involved no clinical intervention, and no risks beyond routine survey participation were anticipated.
Clinical Relevance By evaluating the esthetic impact of digitally simulated mamelon variations under different viewing conditions and observer profiles, this study aims to provide clinically relevant guidance for anterior restorative treatment planning. Understanding how mamelon characteristics influence esthetic perception may assist clinicians in making more patient-centered decisions regarding incisal anatomy in esthetic restorations
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Maltepe
-
Istanbul, Maltepe, Turkey (Türkiye)
- Marmara University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age ≥18 years
- Ability to understand the study information and provide informed consent
- Participation on a voluntary basis
- Completion of the online survey only once
- Belonging to one of the following observer groups:
- Laypersons with no dental education
- Licensed dentists
- Dental specialists in Restorative Dentistry or Prosthodontics
Exclusion Criteria:
- Age <18 years
- Inability to understand the study information or provide informed consent
- Incomplete survey response
- Multiple survey submissions by the same participant
- Participation outside the predefined observer groups
- People with mental illness
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Group/Cohort 1: Laypeople
Laypersons with no formal dental education who participated in the online survey to evaluate digitally modified smile images.
Participants assessed the esthetic attractiveness of full-face and close-up smile photographs using a visual analog scale (VAS).
|
An anonymous web-based survey was used to assess the perception of smile esthetics.
Participants evaluated a total of 18 images (including original and digitally modified full-face and close-up images) using a visual analog scale ranging from 0 (extremely unattractive) to 100 (extremely attractive).
|
|
Group/Cohort 2: Dentists
General dentists who participated in the online survey and evaluated digitally modified smile images.
Participants assessed the esthetic perception of different incisal mamelon configurations using a visual analog scale (VAS).
|
An anonymous web-based survey was used to assess the perception of smile esthetics.
Participants evaluated a total of 18 images (including original and digitally modified full-face and close-up images) using a visual analog scale ranging from 0 (extremely unattractive) to 100 (extremely attractive).
|
|
Group/Cohort 3: Dental Specialists
Dental specialists in Restorative Dentistry and Prosthodontics who participated in the online survey.
Participants evaluated digitally modified smile images with varying mamelon characteristics using a visual analog scale (VAS).
|
An anonymous web-based survey was used to assess the perception of smile esthetics.
Participants evaluated a total of 18 images (including original and digitally modified full-face and close-up images) using a visual analog scale ranging from 0 (extremely unattractive) to 100 (extremely attractive).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perception of smile esthetics with different incisal mamelon configurations
Time Frame: Approximately 10-15 minutes
|
Participants were asked to evaluate the esthetic attractiveness of digitally modified smile images presenting different incisal mamelon configurations.
Evaluations were performed using a visual analog scale (VAS) ranging from 0 (extremely unattractive) to 100 (extremely attractive).
The influence of mamelon length (1 mm vs 3 mm), mamelon value (low vs high), and the number of teeth involved (2 incisors vs 4 incisors) on esthetic perception was assessed.
|
Approximately 10-15 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Effect of image type on esthetic perception
Time Frame: Approximately 10-15 minutes
|
The esthetic perception scores of full-face smile images were compared with close-up smile images to evaluate the effect of viewing distance on the perception of incisal mamelon characteristics.
Evaluations were performed using a visual analog scale (VAS) ranging from 0 to 100.
|
Approximately 10-15 minutes
|
|
Effect of observer group on esthetic perception
Time Frame: Approximately 10-15 minutes
|
Differences in esthetic perception scores among laypersons, dentists, and dental specialists were analyzed to assess the influence of professional background on the evaluation of incisal mamelon characteristics.
All images were rated using a Visual analog scale (minimum 0, maximum 100).
As the score increases, the aesthetic perception value increases.
|
Approximately 10-15 minutes
|
|
Effect of observer gender on esthetic perception
Time Frame: Approximately 10-15 minutes
|
Esthetic perception scores were compared according to the gender of the observers to evaluate potential differences in the perception of digitally simulated incisal mamelon effects.
Ratings were obtained using a visual analog scale (minimum 0, maximum 100).
As the score increases, the aesthetic perception value increases.
|
Approximately 10-15 minutes
|
|
Interaction between mamelon length and value on esthetic perception
Time Frame: Approximately 10-15 minutes
|
The combined effect of mamelon length (1 mm vs 3 mm) and mamelon value (low vs high) on smile esthetic perception was evaluated based on Visual Analog Scale scores obtained from all participant groups.
Visual analog scale (minimum 0, maximum 100).
As the score increases, the aesthetic perception value increases.
|
Approximately 10-15 minutes
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Bora Korkut, Assoc. Prof. Dr., Marmara University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- BK_MarmaraU
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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