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Restorative ExperiencesMamelonEffectNCT07379671

The Effect of the Mamelon Effect on the Perception of Smile Esthetics

An observational study of Restorative Experiences and Esthetic Restorations, run by Marmara University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study aimed to evaluate the role of the mamelon effect on the perception of smile esthetics. A single portrait image was digitally modified by using the Photoshop CC (Adobe, USA) software program to create the mamelon effects at the incisal edge of maxillary incisors. Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
What is being tested?
Online Survey
How many people
135 participants
Where
1 siteTurkey (Türkiye)
Study dates
10 Sep 2024to 20 Dec 2024
Phase
Observational
Are there results?
None posted in the registry

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 18 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: A total of 135 adult participants were included in the study. The study population comprised equal numbers of laypersons, licensed dentists, and dental specialists in Restorative Dentistry or Prosthodontics (n = 45 per group).

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Marmara University

    Istanbul, Maltepe

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of the Mamelon Effect on Upper Incisors on the Perception of Smile Esthetics

This study aimed to evaluate the role of the mamelon effect on the perception of smile esthetics. A single portrait image was digitally modified by using the Photoshop CC (Adobe, USA) software program to create the mamelon effects at the incisal edge of maxillary incisors. Length (cervico-incisal) and value (level of gray color) were the variables in the modified images. There were two length (1mm and 3mm) and two value (low value, LV and high value, HV) modifications performed for the central incisors (2 teeth) and for the central and lateral incisors together (4 teeth). Eight full-face and 8 close-up images were created by cropping the modified images. In total 18 images (including the original ones) were evaluated by the participants. 135 participants (45 dentists, 45 specialists, and 45 laypeople) contributed to an online survey to evaluate the digitally modified images by using a visual analog scale ranging from 0 - 100, according to their level of attractiveness. The data were analyzed using Bonferroni Pairwise Comparisons. The results were presented as average±standard deviation. The deemed significance was set at <.050.

Read the 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

Being tested
Online Survey

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Online SurveyOther

    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).

Study groups in NCT07379671
Study groupRoleWhat they receive
Group/Cohort 1: LaypeopleLaypersons 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).
Receives: Other: Online Survey
Group/Cohort 2: DentistsGeneral 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).
Receives: Other: Online Survey
Group/Cohort 3: Dental SpecialistsDental 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).
Receives: Other: Online Survey

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Perception of smile esthetics with different incisal mamelon configurations

    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.

    Measured: Approximately 10-15 minutes

Secondary outcomes (4)
  1. Effect of image type on esthetic perception

    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.

    Measured: Approximately 10-15 minutes

  2. Effect of observer group on esthetic perception

    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.

    Measured: Approximately 10-15 minutes

  3. Effect of observer gender on esthetic perception

    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.

    Measured: Approximately 10-15 minutes

  4. Interaction between mamelon length and value on esthetic perception

    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.

    Measured: Approximately 10-15 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jan 2026
  2. Study start10 Sep 2024
  3. Primary completion10 Oct 2024
  4. Study completion20 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
135 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07379671
Sponsor's protocol ID
BK_MarmaraU
Acronym
MamelonEffect
Status last verified
Jan 2026
First submitted
13 Jan 2026
Last updated
30 Jan 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Only IPD used in the results publication.

Questions about this trial

What is this clinical trial studying?

An observational study of Restorative Experiences and Esthetic Restorations, run by Marmara University at 1 site in Turkey (Türkiye).

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 8 inclusion and 6 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: finished, as of the sponsor's last update on 30 Jan 2026. 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 Turkey (Türkiye). 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Perception of smile esthetics with different incisal mamelon configurations (time frame: Approximately 10-15 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 30 Jan 2026.

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