Gingival ThicknessNCT03628742
The Use Of Specially Designed Probe Versus Cone- Beam Computerized Tomography In The Measurement Of Gingival Thickness: Diagnostic Accuracy Study
An observational study of Gingival Thickness and Gingival Biotype, run by Cairo University.
Trial summary
Accurate measurement of gingival thickness is crucial for decision making in the field of Periodontology and implant dentistry. Currently implemented techniques for the detection of gingival biotype are of limited reliability. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Gingival Thickness, Gingival Biotype, Periodontal Probe
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 20 Aug 2018to 1 May 2019
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The patient will be selected from the Out Patient Clinic from Oral Medicine and Periodontology Department, Faculty of Dentistry Cairo University.
Who may be able to join
- In periodontally healthy individuals.
- Patients with condition indicated for CBCT in upper anterior region
- Patient age 18-50 years.
- Intact maxillary central incisors.
Who cannot join
- Pathological lesion in examined site.
- Any tooth Malalignment in the examined site.
- Patients using drugs which may induce gingival enlargement.
- Pregnant females.
- Any tooth with any metal restoration in the examined site.
About this study
Accurate measurement of gingival thickness is crucial for decision making in the field of Periodontology and implant dentistry. Currently implemented techniques for the detection of gingival biotype are of limited reliability. They possess different drawbacks leading to the necessity for the development of a new method to overcome disadvantages of the available techniques.
the rational of this study is to determine the accuracy of a specially designed probe in comparison to cone- beam computerized tomography which is accurate enough as found by Fu et al 2010.
Read the detailed description
The success of the esthetic outcome for the anterior teeth restorations and periodontal surgeries depends on several factors such as the gingival biotype, teeth alignment and architecture of the gingiva.
The first who introduced the term biotype are Seibert and Lindhe 1989, they categorized the gingiva to ''thick-flat'' and ''thin-scalloped'' biotypes . Thick biotype is associated with broad tissue and flat gingiva which is also supported by thick bony plate. Thin biotype is associated with thin band of keratinized tissue and scalloped gingiva which is supported by thin bony plate.
A gingival thickness of more or equal to 2 mm is defined as thick biotype and a gingival thickness of less than 1.5 mm as thin biotype. Different gingival biotypes response in different ways to inflammation, restorative and periodontal surgery .
The gingival thickness may predict the outcome of periodontal and restorative treatments. For implant surgery, implant in thin biotype will lead to future peri-implant mucosal recession . The gingival thickness affects the treatment outcome possibly because of the difference in the amount of blood supply of the underlying bone and susceptibility to resorption .
Multiple techniques were proposed to measure the tissue thickness , such as direct measurement ultrasonic devices probe transparency method and cone-beam computed tomography scan
In the direct method, the tissue thickness is measured using a periodontal probe. This method has limitations, such as the angulation of the probe during probing and distortion of tissue during probing
Transgingival method is a simple method to discriminate thin gingival based on the transparency of the periodontal probe through the gingival margin This method was found to be highly reproducible with 85% intra examiner repeatability in a clinical trial of 100 periodontally healthy area . However, this method immeasurable and when presence of pigmented gingiva sometimes hampers the correct identification of gingival biotype .
Another method that was introduced as one of the gingival biotype diagnostic methods is Cone-beam computerized tomography (CBCT), which is widely used to analyze the maxillofacial region . The first who presented commercial CBCT system was Mozzo et al., 1998 . The CBCT offers high-quality diagnostic method and it has become essential in dental practice.
Lascala et al., 2004 have shown the reliability and accuracy when measuring anatomical structures from CBCT images and compared them with measurements of real distances of dry skulls . It was previously reported that CBCT is not indicated for evaluating soft tissue appearance and thickness, and it was considered as a tool for exclusively evaluating hard tissues of the maxillofacial complex . However, recently it has been reported that CBCT can be applied for visualizing and measuring soft tissues of the dento-gingival unit ). Fu et al., 2010 also stated that CBCT provides accurate measurements of both bone and labial soft tissue thickness when compared to caliper method .
A new simple probe is specially designed in an attempt to overcome the angulation problem of the direct method, the complexity and high cost of CBCT and the limitation of the transgingival method.
Aim of Study:
The aim of the study is the evaluation of the use of specially designed probe versus cone- beam computerized tomography in measurement of gingival thickness.
- Conditions
- Gingival Thickness, Gingival Biotype, Periodontal Probe
- Keywords
- periodontal probe, gingival thickness, gingival biotype
What is being measured
The primary outcome is the main question the study is designed to answer.
Special Designed Probe
Assessment of the diagnostic accuracy of Specially designed probe in measuring the gingival thickness in millimeter unit
Measured: finish the trial in 1 years from the clinical trial registration ( May 2019)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2018
- Study start20 Aug 2018 (estimated)
- Primary completion1 Dec 2018 (estimated)
- Study completion1 May 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival ThicknessStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deyaa Darwish, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03628742
- Sponsor's protocol ID
- cairo univesity
- Status last verified
- Aug 2018
- First submitted
- 21 Jun 2018
- Last updated
- 14 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use Of Specially Designed Probe Versus Cone- Beam Computerized Tomography In The Measurement Of Gingival Thickness: Diagnostic Accuracy Study
- ClinicalTrials.gov ID
- NCT03628742
- Acronym / sponsor ID
- cairo univesity
- Conditions
- Gingival Thickness, Gingival Biotype, Periodontal Probe
- Keywords
- periodontal probe, gingival thickness, gingival biotype
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Aug 2018 (estimated)
- Primary completion
- 1 Dec 2018 (estimated)
- Study completion
- 1 May 2019 (estimated)
- First posted
- 14 Aug 2018 (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.
Accurate measurement of gingival thickness is crucial for decision making in the field of Periodontology and implant dentistry. Currently implemented techniques for the detection of gingival biotype are of limited reliability. They possess different drawbacks leading to the necessity for the development of a new method to overcome disadvantages of the available techniques.
the rational of this study is to determine the accuracy of a specially designed probe in comparison to cone- beam computerized tomography which is accurate enough as found by Fu et al 2010.
Detailed description
The success of the esthetic outcome for the anterior teeth restorations and periodontal surgeries depends on several factors such as the gingival biotype, teeth alignment and architecture of the gingiva.
The first who introduced the term biotype are Seibert and Lindhe 1989, they categorized the gingiva to ''thick-flat'' and ''thin-scalloped'' biotypes . Thick biotype is associated with broad tissue and flat gingiva which is also supported by thick bony plate. Thin biotype is associated with thin band of keratinized tissue and scalloped gingiva which is supported by thin bony plate.
A gingival thickness of more or equal to 2 mm is defined as thick biotype and a gingival thickness of less than 1.5 mm as thin biotype. Different gingival biotypes response in different ways to inflammation, restorative and periodontal surgery .
The gingival thickness may predict the outcome of periodontal and restorative treatments. For implant surgery, implant in thin biotype will lead to future peri-implant mucosal recession . The gingival thickness affects the treatment outcome possibly because of the difference in the amount of blood supply of the underlying bone and susceptibility to resorption .
Multiple techniques were proposed to measure the tissue thickness , such as direct measurement ultrasonic devices probe transparency method and cone-beam computed tomography scan
In the direct method, the tissue thickness is measured using a periodontal probe. This method has limitations, such as the angulation of the probe during probing and distortion of tissue during probing
Transgingival method is a simple method to discriminate thin gingival based on the transparency of the periodontal probe through the gingival margin This method was found to be highly reproducible with 85% intra examiner repeatability in a clinical trial of 100 periodontally healthy area . However, this method immeasurable and when presence of pigmented gingiva sometimes hampers the correct identification of gingival biotype .
Another method that was introduced as one of the gingival biotype diagnostic methods is Cone-beam computerized tomography (CBCT), which is widely used to analyze the maxillofacial region . The first who presented commercial CBCT system was Mozzo et al., 1998 . The CBCT offers high-quality diagnostic method and it has become essential in dental practice.
Lascala et al., 2004 have shown the reliability and accuracy when measuring anatomical structures from CBCT images and compared them with measurements of real distances of dry skulls . It was previously reported that CBCT is not indicated for evaluating soft tissue appearance and thickness, and it was considered as a tool for exclusively evaluating hard tissues of the maxillofacial complex . However, recently it has been reported that CBCT can be applied for visualizing and measuring soft tissues of the dento-gingival unit ). Fu et al., 2010 also stated that CBCT provides accurate measurements of both bone and labial soft tissue thickness when compared to caliper method .
A new simple probe is specially designed in an attempt to overcome the angulation problem of the direct method, the complexity and high cost of CBCT and the limitation of the transgingival method.
Aim of Study:
The aim of the study is the evaluation of the use of specially designed probe versus cone- beam computerized tomography in measurement of gingival thickness.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The patient will be selected from the Out Patient Clinic from Oral Medicine and Periodontology Department, Faculty of Dentistry Cairo University.
Key inclusion criteria (4 listed)
- In periodontally healthy individuals.
- Patients with condition indicated for CBCT in upper anterior region
- Patient age 18-50 years.
- Intact maxillary central incisors.
Key exclusion criteria (5 listed)
- Pathological lesion in examined site.
- Any tooth Malalignment in the examined site.
- Patients using drugs which may induce gingival enlargement.
- Pregnant females.
- Any tooth with any metal restoration in the examined site.
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
Special Designed Probe
Time frame: finish the trial in 1 years from the clinical trial registration ( May 2019)
Assessment of the diagnostic accuracy of Specially designed probe in measuring the gingival thickness in millimeter unit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2018.
Related trials for Gingival Thickness
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Thin Gingival Phenotype
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Hyaluronic Acid vs I-PRF With Microneedling in Enhancing Peri-implant Soft Tissue
Peri-implant Mucosa Thickness
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Early Effects of Orthognathic Surgery on Periodontal Phenotype: A 6-Month Prospective Clinical and Radiographic Evaluation
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V-Reverse Suture Technique Compared to Traditional Anchored Sling Suture in Treating Multiple Gingival Recession
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Adding Effect of Cross-linked Hyaluronic Acid to Microneedling After Coronally Advanced Flap in Isolated RT1 Recession
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Gingival Thickness and Gingival Biotype, run by Cairo University.
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 4 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: status not confirmed, as of the sponsor's last update on 14 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Special Designed Probe (time frame: finish the trial in 1 years from the clinical trial registration ( May 2019)). 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 14 Aug 2018.