Digital PhotographyNCT07199686
Digital Color Analysis of the Graft and Recipient Site After Free Gingival Graft Surgery
An observational study of Digital Photography and Cross Polarized Filter, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
This study evaluates gingival color following Free Gingival Graft (FGG) surgery using polarized digital photography to objectively analyze grafted and adjacent tissues. Conventional verbal descriptors (e.g., pale pink, salmon pink) lack precision; therefore, digital colorimetry provides objective, non-contact, and… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Digital Photography, Cross Polarized Filter, Free Gingival Graft
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Mar 2023to 20 Apr 2025
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This retrospective cohort study included patients from the Department of Periodontology, Faculty of Dentistry, Bezmialem Vakıf University, who had undergone conventional free gingival graft (FGG) in the mandibular anterior region involving one or two teeth.
Who may be able to join
- Postoperative period of at least 6 months after FGG
- Age between 18 and 65 years
- No known systemic diseases
- No use of medications adversely affecting gingival health (e.g., calcium channel blockers, immunosuppressants, antiepileptics)
- Full-mouth plaque index (PI)(1) and gingival index (GI)(2) < 1
- Probing pocket depth (PPD) ≤ 3 mm with no bleeding on probing (BOP)(3) in the mandibular anterior teeth
- Absence of habitual mouth breathing
Who cannot join
- Current smoking
- Pregnancy or lactation
- Previous endodontic or restorative treatment in the mandibular anterior teeth
- Parafunctional habits (e.g., bruxism) or history of orthodontic treatment
- Conditions impairing salivary flow (e.g., Sjögren's syndrome or similar disorders)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bezmialem Vakif University
Istanbul, Fatih, 34093
About this study
Official title: Color Analysis of Graft and Recipient Site After Free Gingival Graft Surgery Using Polarized Digital Photograph
This study evaluates gingival color following Free Gingival Graft (FGG) surgery using polarized digital photography to objectively analyze grafted and adjacent tissues. Conventional verbal descriptors (e.g., pale pink, salmon pink) lack precision; therefore, digital colorimetry provides objective, non-contact, and reproducible measurements. The protocol utilizes the CIELab system with standardized color disks and polarization to document postoperative color changes accurately.
The study objectives are: (1) to determine CIELab color values of FGG-treated gingiva in patients who underwent conventional surgery at least six months earlier; (2) to assess the influence of age, sex, time since surgery, and gingival thickness on these values; and (3) to compare graft color with adjacent gingiva.
Hypothesis: In FGG-treated patients, graft CIELab color values are unaffected by age, sex, postoperative duration, or gingival thickness.
Read the detailed description
The aim of this cross-sectional study was to evaluate the color characteristics of free gingival graft (FGG) and the adjacent gingiva using polarized filtered digital photographs in cases where more than six months have elapsed since the procedure, and to assess the potential influence of clinical and sociodemographic factors on gingival color.
Fifty cases involving FGG procedures covering one or two lower anterior incisors were included in the study. Clinical parameters including probing pocket depth, bleeding on probing, clinical attachment level, width of keratinized gingiva, and thickness of keratinized gingiva were recorded. Standardized color reference disks were placed on the labial surfaces of the treated teeth, and both filtered and unfiltered photographs were taken. The images were saved in JPEG format and analyzed using the CIELab color system in Adobe Photoshop. A p-value of less than 0.05 was considered statistically significant.
- Keywords
- CIELab, Digital color analysis, cross-polarized filter, free gingival graft, gingiva color
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Clinical Periodontal Measurements and Digital Imaging | For each tooth within the FGG treated sites, probing pocket depth (PD), clinical attachment level (CAL), and keratinized gingiva width (KGW) were recorded. The thickness of the FGG and adjacent keratinized gingiva (KG) was assessed using a transgingival method. Standardized intraoral photographs were obtained from the study population. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterization of the color values of the Free Gingival Graft (FGG) according to the CIELab color system
Standardized intraoral photographs were obtained from fifty participants. Digital images were obtained using a camera with standardized settings to ensure reproducibility. All images, taken with and without the filter. Photographs were analyzed in Adobe Photoshop programme using the CIELAB system. The FGG region was divided into three equal zones (coronal, middle, apical). For each region, mean L*, a*, and b* values were calculated.
Measured: Through study completion, an average of 6 months
Characterization of the color values of the adjacent keratinized gingiva according to the CIELab color system
Standardized intraoral photographs were obtained from fifty participants. Digital images were obtained using a camera with standardized settings to ensure reproducibility. All images, taken with and without the filter. Photographs were analyzed in Adobe Photoshop programme using the CIELAB system. The adjacent keratized gingiva region was divided into two equal zones (coronal and middle) as the apical region corresponded to non-keratinized mucosa. For each region, mean L*, a*, and b* values were calculated.
Measured: Through study completion, an average of 6 months
Secondary outcomes (8)
Keratinized Gingiva Width
For teeth within the operative area, the distance between the mucogingival junction and the gingival margin at the mesial, middle, and distal sites was measured. The mean of these three values was recorded as the keratinized gingiva width (KGW) for each tooth.
Measured: Baseline
Periodontal pocket depth
Periodontal pocket depth (PPD) was measured as the distance from the gingival margin to the base of the pocket at the mesio-buccal, mid-buccal, and disto-buccal surfaces of each tooth in the operative region. The mean of these three measurements was recorded as the PPD value for the tooth.
Measured: Baseline
Clinical attachment level
Clinical attachment level (CAL) was measured as the distance from the mesial, mid-buccal, and distal aspects of each tooth within the surgical area to the cemento-enamel junction (CEJ) and extended to the depth of the periodontal pocket. The mean of these three measurements was recorded, and the CAL for each tooth was determined accordingly.Time Frame:At the time of examination.
Measured: Baseline
Measurement of gingival thickness
The thickness of the free gingival graft (FGG) and adjacent keratinized gingiva (KG) was assessed using a transgingival probing method. After administering local anesthesia, a #25 endodontic spreader was inserted perpendicularly through the mucosa until it contacted the underlying hard tissue. The distance between the spreader tip and the stopper was measured with a digital caliper. In the FGG area, measurements were obtained at three points (mesial, middle, and distal). In the adjacent keratinized tissue, two measurements were taken 2 mm apical to the gingival margin of the neighboring tooth, corresponding to the coronal and mid-regions of the graft.
Measured: Baseline
Influence of age on color values
Patient age was recorded, and the effect of age (year) on the CIELab values of the graft was assessed via One way Multivariate Analysis of Variance.
Measured: Through study completion, an average of 6 months
Influence of 'time since surgery' on color values
The duration 'since FGG surgery (months)' was recorded, and its effect on the CIELab values of the graft was assessed via One way Multivariate Analysis of Variance.
Measured: Through study completion, an average of 6 months
Influence of gender on color values
Patient gender (female/male) was recorded, and the effect of gender (female/male) on the CIELab values of the graft was assessed via One way Multivariate Analysis of Variance.
Measured: Through study completion, an average of 6 months
Influence of gingival thickness on color values
Gingival thickness was recorded, and the effect of gingival thickness (mm) on the CIELab values of the graft was assessed via One way Multivariate Analysis of Variance
Measured: Through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2025
- Study start20 Mar 2023
- Primary completion5 Aug 2023
- Study completion20 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Digital PhotographyStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07199686
- Sponsor's protocol ID
- SKOLE
- Other IDs
- 2025\46
- Status last verified
- Sep 2025
- First submitted
- 10 Sep 2025
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Color Analysis of Graft and Recipient Site After Free Gingival Graft Surgery Using Polarized Digital Photograph
- ClinicalTrials.gov ID
- NCT07199686
- Acronym / sponsor ID
- SKOLE
- Keywords
- CIELab, Digital color analysis, cross-polarized filter, free gingival graft, gingiva color
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 20 Mar 2023 (actual)
- Primary completion
- 5 Aug 2023 (actual)
- Study completion
- 20 Apr 2025 (actual)
- First posted
- 30 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates gingival color following Free Gingival Graft (FGG) surgery using polarized digital photography to objectively analyze grafted and adjacent tissues. Conventional verbal descriptors (e.g., pale pink, salmon pink) lack precision; therefore, digital colorimetry provides objective, non-contact, and reproducible measurements. The protocol utilizes the CIELab system with standardized color disks and polarization to document postoperative color changes accurately.
The study objectives are: (1) to determine CIELab color values of FGG-treated gingiva in patients who underwent conventional surgery at least six months earlier; (2) to assess the influence of age, sex, time since surgery, and gingival thickness on these values; and (3) to compare graft color with adjacent gingiva.
Hypothesis: In FGG-treated patients, graft CIELab color values are unaffected by age, sex, postoperative duration, or gingival thickness.
Detailed description
The aim of this cross-sectional study was to evaluate the color characteristics of free gingival graft (FGG) and the adjacent gingiva using polarized filtered digital photographs in cases where more than six months have elapsed since the procedure, and to assess the potential influence of clinical and sociodemographic factors on gingival color.
Fifty cases involving FGG procedures covering one or two lower anterior incisors were included in the study. Clinical parameters including probing pocket depth, bleeding on probing, clinical attachment level, width of keratinized gingiva, and thickness of keratinized gingiva were recorded. Standardized color reference disks were placed on the labial surfaces of the treated teeth, and both filtered and unfiltered photographs were taken. The images were saved in JPEG format and analyzed using the CIELab color system in Adobe Photoshop. A p-value of less than 0.05 was considered statistically significant.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clinical Periodontal Measurements and Digital Imaging | – | –For each tooth within the FGG treated sites, probing pocket depth (PD), clinical attachment level (CAL), and keratinized gingiva width (KGW) were recorded. The thickness of the FGG and adjacent keratinized gingiva (KG) was assessed using a transgingival method. Standardized intraoral photographs were obtained from the study population. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This retrospective cohort study included patients from the Department of Periodontology, Faculty of Dentistry, Bezmialem Vakıf University, who had undergone conventional free gingival graft (FGG) in the mandibular anterior region involving one or two teeth.
Key inclusion criteria (7 listed)
- Postoperative period of at least 6 months after FGG
- Age between 18 and 65 years
- No known systemic diseases
- No use of medications adversely affecting gingival health (e.g., calcium channel blockers, immunosuppressants, antiepileptics)
- Full-mouth plaque index (PI)(1) and gingival index (GI)(2) < 1
Key exclusion criteria (5 listed)
- Current smoking
- Pregnancy or lactation
- Previous endodontic or restorative treatment in the mandibular anterior teeth
- Parafunctional habits (e.g., bruxism) or history of orthodontic treatment
- Conditions impairing salivary flow (e.g., Sjögren's syndrome or similar disorders)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Characterization of the color values of the Free Gingival Graft (FGG) according to the CIELab color system
Time frame: Through study completion, an average of 6 months
Standardized intraoral photographs were obtained from fifty participants. Digital images were obtained using a camera with standardized settings to ensure reproducibility. All images, taken with and without the filter. Photographs were analyzed in Adobe Photoshop programme using the CIELAB system. The FGG region was divided into three equal zones (coronal, middle, apical). For each region, mean L*, a*, and b* values were calculated.
Characterization of the color values of the adjacent keratinized gingiva according to the CIELab color system
Time frame: Through study completion, an average of 6 months
Standardized intraoral photographs were obtained from fifty participants. Digital images were obtained using a camera with standardized settings to ensure reproducibility. All images, taken with and without the filter. Photographs were analyzed in Adobe Photoshop programme using the CIELAB system. The adjacent keratized gingiva region was divided into two equal zones (coronal and middle) as the apical region corresponded to non-keratinized mucosa. For each region, mean L*, a*, and b* values were calculated.
8 secondary outcomes
Keratinized Gingiva Width
Time frame: Baseline
Periodontal pocket depth
Time frame: Baseline
Clinical attachment level
Time frame: Baseline
Measurement of gingival thickness
Time frame: Baseline
Influence of age on color values
Time frame: Through study completion, an average of 6 months
Influence of 'time since surgery' on color values
Time frame: Through study completion, an average of 6 months
Influence of gender on color values
Time frame: Through study completion, an average of 6 months
Influence of gingival thickness on color values
Time frame: Through study completion, an average of 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Digital Photography and Cross Polarized Filter, run by Bezmialem Vakif 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 7 inclusion and 5 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 Sep 2025. 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?
Characterization of the color values of the Free Gingival Graft (FGG) according to the CIELab color system (time frame: Through study completion, an average of 6 months). The study lists 2 primary outcomes in all. 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 Sep 2025.