Gingival PhenotypeNCT05706480
Assessment of Gingival Thickness Using Colored Periodontal Probe
An observational study of Gingival Phenotype, run by Misr International University at 1 site in Egypt.
Trial summary
the accuracy of different assessment methods of the gingival tissue thickness can be controversial affecting their correct classification and the techniques of gingival tissue management in case of mucogingival problems. Read more about this study
- Who is it for?
- Ages 16 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Phenotype
- What is being tested?
- colored periodontal probes (CPP), standard periodontal probes (SPP) and transgingival sounding with an endodontic file
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2024to 1 Mar 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 16 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Periodontally clinically healthy patients, aged from 18 to 65 years old, with the presence of anterior teeth in mandible and maxilla and good oral hygiene
Who may be able to join
- Systemically free patients (American Society of Anesthesiologists (ASA) I or II)
- Patients having a state of clinical periodontal health
- Patients aged from 18 to 65 years old
- Both genders
- Presence of anterior teeth in mandible and maxilla.
- Good oral hygiene
Who cannot join
- Carious teeth, teeth with crowns or veneers and non-carious cervical lesions
- Patients with healthy reduced periodontium.
- Smokers
- Pregnant and lactating females
- Patients taking drugs that affect the gingival tissues
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of oral and dental medicine, Misr international university
Cairo, 12345
About this study
Official title: Assessment of Gingival Thickness Using Colored Periodontal Probe Assessment Method: A Cross-Sectional Study
the accuracy of different assessment methods of the gingival tissue thickness can be controversial affecting their correct classification and the techniques of gingival tissue management in case of mucogingival problems.
Aim: The aim of this study is to evaluate the accuracy of different assessment methods of measuring GT and to classify into the different gingival phenotypes.
Read the detailed description
The accuracy of different assessment methods of the gingival tissue thickness can be controversial affecting their correct classification and the techniques of gingival tissue management in case of mucogingival problems.
The aim of this study is to evaluate the accuracy of different assessment methods of measuring GT and to classify into the different gingival phenotypes.
Periodontally clinically healthy patients will be recruited from the Dental Clinic Complex (MIU) according to eligibility criteria. The gingival tissue thickness will be measured using probe-colored periodontal probes (CPP), standard periodontal probes (SPP) and transgingival sounding with an endodontic file (ISO #20), visual judgment using photographs will be done to the three assessment methods. All readings including GT (1ry outcome) as well as keratinized tissue width and probing depth will be carried out by three calibrated outcome assessors. Data collected will be tabulated and statistically analyzed.
- Conditions
- Gingival Phenotype
- Being tested
- colored periodontal probes (CPP), standard periodontal probes (SPP), transgingival sounding with an endodontic file
- Keywords
- Gingival thickness, Colored periodontal probe (CPP), Standard periodontal probe (SPP), Trans gingival sounding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
colored periodontal probes (CPP)Diagnostic test
The CPP will be placed with a force of approximately 0.2 N into the sulcus at the mid buccal surface of the tooth and the color that will be apparent from the tissue will be recorded
standard periodontal probes (SPP)Diagnostic test
The SPP (William's graduated probe) will be placed with a force of approximately 0.2 N into the sulcus at the mid buccal surface of the tooth and the color that will be apparent from the tissue will be recorded
transgingival sounding with an endodontic fileDiagnostic test
the gingival thickness using the transgingival sounding. After application of local anesthesia gel an endodontic file (ISO 20) with a rubber stopper will be inserted perpendicularly into the buccal aspect of the gingiva (1 mm below the gingival margin) until it touches the tooth surface. The insertion depth will be ensured through placing the rubber stopper in contact with the gingiva and fixing its position and the distance between the tip and the rubber stopper will be calibrated using a manual calibration device (endodontic ruler).
| Study group | Role | What they receive |
|---|---|---|
| Periodontally clinically healthy patients | In Periodontally clinically healthy patients fulfilling the eligibility criteria. The gingival tissue thickness will be measured using probe-colored periodontal probes (CPP), standard periodontal probes (SPP) and transgingival sounding with an endodontic file (ISO #20), visual judgment using photographs will be done to the three assessment methods Receives: Diagnostic Test: colored periodontal probes (CPP); Diagnostic Test: standard periodontal probes (SPP); Diagnostic Test: transgingival sounding with an endodontic file |
What is being measured
The primary outcome is the main question the study is designed to answer.
gingival thickness
determination of the thickness of the gingival tissues
Measured: baseline
Secondary outcomes (2)
Keratinized tissue width
measuring the width of the keratinized tissue width in mm
Measured: baseline
Probing depth
measuring of the distance from the gingival margin to the base of the pocket in mm
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2023
- Study start1 Dec 2024
- Primary completion1 Feb 2025
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival PhenotypeStudies of the same condition, open and under way.
- 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Misr International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zainab Hafez, Lecturer, Principal investigator, Lecturer, faculty of oral and dental medicine misr international universityShahinaz Al ashiry, Asso. Prof, Study director, Associate professor, faculty of oral and dental medicine misr international universityYahia Hassan, Lecturer, Principal investigator, Lecturer, faculty of oral and dental medicine misr international universit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05706480
- Sponsor's protocol ID
- PER 4261006
- Status last verified
- Nov 2024
- First submitted
- 23 Jan 2023
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Gingival Thickness Using Colored Periodontal Probe Assessment Method: A Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT05706480
- Acronym / sponsor ID
- PER 4261006
- Conditions
- Gingival Phenotype
- Keywords
- Gingival thickness, Colored periodontal probe (CPP), Standard periodontal probe (SPP), Trans gingival sounding
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Misr International UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 1 Feb 2025 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 31 Jan 2023 (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.
the accuracy of different assessment methods of the gingival tissue thickness can be controversial affecting their correct classification and the techniques of gingival tissue management in case of mucogingival problems.
Aim: The aim of this study is to evaluate the accuracy of different assessment methods of measuring GT and to classify into the different gingival phenotypes.
Detailed description
The accuracy of different assessment methods of the gingival tissue thickness can be controversial affecting their correct classification and the techniques of gingival tissue management in case of mucogingival problems.
The aim of this study is to evaluate the accuracy of different assessment methods of measuring GT and to classify into the different gingival phenotypes.
Periodontally clinically healthy patients will be recruited from the Dental Clinic Complex (MIU) according to eligibility criteria. The gingival tissue thickness will be measured using probe-colored periodontal probes (CPP), standard periodontal probes (SPP) and transgingival sounding with an endodontic file (ISO #20), visual judgment using photographs will be done to the three assessment methods. All readings including GT (1ry outcome) as well as keratinized tissue width and probing depth will be carried out by three calibrated outcome assessors. Data collected will be tabulated and statistically analyzed.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Periodontally clinically healthy patients | – | Diagnostic Test: colored periodontal probes (CPP), Diagnostic Test: standard periodontal probes (SPP), Diagnostic Test: transgingival sounding with an endodontic fileIn Periodontally clinically healthy patients fulfilling the eligibility criteria. The gingival tissue thickness will be measured using probe-colored periodontal probes (CPP), standard periodontal probes (SPP) and transgingival sounding with an endodontic file (ISO #20), visual judgment using photographs will be done to the three assessment methods |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Periodontally clinically healthy patients, aged from 18 to 65 years old, with the presence of anterior teeth in mandible and maxilla and good oral hygiene
Key inclusion criteria (6 listed)
- Systemically free patients (American Society of Anesthesiologists (ASA) I or II)
- Patients having a state of clinical periodontal health
- Patients aged from 18 to 65 years old
- Both genders
- Presence of anterior teeth in mandible and maxilla.
Key exclusion criteria (5 listed)
- Carious teeth, teeth with crowns or veneers and non-carious cervical lesions
- Patients with healthy reduced periodontium.
- Smokers
- Pregnant and lactating females
- Patients taking drugs that affect the gingival tissues
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| colored periodontal probes (CPP)The CPP will be placed with a force of approximately 0.2 N into the sulcus at the mid buccal surface of the tooth and the color that will be apparent from the tissue will be recorded | Diagnostic test | Periodontally clinically healthy patients |
| standard periodontal probes (SPP)The SPP (William's graduated probe) will be placed with a force of approximately 0.2 N into the sulcus at the mid buccal surface of the tooth and the color that will be apparent from the tissue will be recorded | Diagnostic test | Periodontally clinically healthy patients |
| transgingival sounding with an endodontic filethe gingival thickness using the transgingival sounding. After application of local anesthesia gel an endodontic file (ISO 20) with a rubber stopper will be inserted perpendicularly into the buccal aspect of the gingiva (1 mm below the gingival margin) until it touches the tooth surface. The insertion depth will be ensured through placing the rubber stopper in contact with the gingiva and fixing its position and the distance between the tip and the rubber stopper will be calibrated using a manual calibration device (endodontic ruler). | Diagnostic test | Periodontally clinically healthy patients |
Primary outcome
gingival thickness
Time frame: baseline
determination of the thickness of the gingival tissues
2 secondary outcomes
Keratinized tissue width
Time frame: baseline
Probing depth
Time frame: baseline
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 11 Mar 2025.
- Individual participant dataSharing planned: Undecided
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Injectable Platelet-Rich Fibrin and Microneedling With or Without Vitamin C for Gingival Phenotype Augmentation.
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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.
Zainab Hafez, Lecturer principal investigator
Lecturer, faculty of oral and dental medicine misr international university
Shahinaz Al ashiry, Asso. Prof study director
Associate professor, faculty of oral and dental medicine misr international university
Yahia Hassan, Lecturer principal investigator
Lecturer, faculty of oral and dental medicine misr international universit
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 Gingival Phenotype, run by Misr International University at 1 site in Egypt.
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 6 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 11 Mar 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 Egypt. 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?
gingival thickness (time frame: baseline). 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 11 Mar 2025.