Periodontal DiseasesNCT04640506
Accuracy of Assessing the Gingival Biotype in Upper Anterior in Adult Patients, Using Different Methods.
An observational study of Periodontal Diseases, run by Cairo University at 1 site in Egypt.
Trial summary
The study is a Diagnostic accuracy study that determining the accuracy of assessing the gingival biotype and some other anatomic parameters,including (crown width / crown length ratio, attached gingival width, labial bone thickness and papilla volume) by different methods :1- probe transparency, 2-transgingival… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases
- How many people
- 63 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2020to Aug 2021
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Adult Egyptian dental patients receiving esthetic rehabilitation treatment (implant placement, restorative treatments, periodontal therapy, and root cov¬erage) on anterior maxilla at faculty of Dentistry, Cairo University.
Who may be able to join
- Male and female Patients whose age is between 18 to 40 years old.
- Health teeth only will be included.
- Patients who already need esthetic rehabilitation treatment (implant placement, restorative treatments, periodontal therapy, and root coverage) on anterior maxilla and this treatment needs to investigate the gingival biotype.
- An un-inflamed periodontal condition with a periodontal probing depth of no more than 3 mm, a bleeding index of < 2, and no gingival recession on maxillary anterior teeth.
- Provide informed consent.
Who cannot join
- Pregnant or lactating females.
- Restoration or crowns in the maxillary anterior dentition.
- Malocclusion.
- Use of any medication affecting the soft tissue.
- Cigarette smoking.
- Individuals with chronic systemic diseases such as diabetes, endocrine and haematological pathologies.
Show all 9Show fewer
- Patients having problem in opening their mouth or undergoing inter-maxillary fixation where oral examination will not be possible.
- Patients diagnosed with psychiatric problems or intoxicated with alcohol or drugs.
- Patients with congenital disorders or craniofacial anomalies such as cleft lip and palate
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Fahd Ayad hammoodi Al-janabi
Giza
Fahd Ayad Al-janabi, Master, 00201144464491, Fahd.ayad92@gmail.com
About this study
Official title: Accuracy of Assessing the Gingival Biotype in the Anterior Maxillary Area in Adult Patients, Using Different Measurement Methods.
The study is a Diagnostic accuracy study that determining the accuracy of assessing the gingival biotype and some other anatomic parameters,including (crown width / crown length ratio, attached gingival width, labial bone thickness and papilla volume) by different methods :1- probe transparency, 2-transgingival probing, 3-cone beam computed tomography, 4-intraoral digital scanning, 5-extraoral digital scanning
Read the detailed description
- Patients will be recruited in periodontic department faculty of dentistry Cairo university.
- Patients who already need esthetic rehabilitation treatment (implant placement, restorative treatments, periodontal therapy, and root coverage) on anterior maxilla and this treatment needs to investigate the gingival biotype.
- Medical history will be taken.
- Oral examination will be done.
- Full mouth periodontal examination and charting will be done for each patient.
- The investigation will be explained to the patient.
- All the investigations will be carried out by one investigator.
- Dental patients will be received to the clinic (for esthetic rehabilitation treatment such as implant placement, restorative treatments, periodontal therapy, and root coverage on anterior maxilla).
- Patients who needs treatment will be investigated the gingival biotype by the five measurement methods (PT, TP, CBCT, IDS and EDS).
- Patients refusing to participate will be reported with the cause of their refusal.
- Conventional clinical examination will be held on a dental unit using the light of the unit, mirror and probe.
- Before the investigation, the aim of the study will be explained to the patient and the patient's acceptance to participate in the survey will be obtained.
- Periodontal status will be evaluated including assessment of gingival index (GI), plaque index (PI), probing pocket depth (PPD) on aesthetic zone in maxillary teeth by using UNC 15 periodontal probe which is 15mm long probe with markings at each millimetre and colour coded at 5th,10th and 15th mm.
- Then an investigator will evaluate the gingival biotype by probing Transparency (PT) as reported by (Kan et al., 2010). The periodontal probe will be softly inserted into the gingival sulcus till it reaches the sound bone on the labial side of the maxil¬lary anterior teeth and it will be parallel to the long axis of the crown. The gingival biotype will be considered as thick if the probe tip is not seen into the tissue and it will be considered as thin if the probe was seen. If the thick en d of the probe was seen into the tissue but the thin end was not, then it will be considered as a moderate biotype.
- The second method of assessment to the gingival biotype will be carried out using CBCT with lip retraction. It is important to note that the patients will not receive additional radiation exposure for the purpose of this investigation and to give us clear details about soft tissue, patients have already underwent CBCT examination as an investigation method for aesthetic rehabilitation treatment.
- Afterwards, gingival biotype assessment will be done by intraoral digital examination (Kim et al., 2016). This is the third method; the investigation of gingival biotype of the anterior maxilla will be done by means of a three-dimensional intraoral scanner. The intraoral scanning data will be acquired in stereolithogra¬phy (STL) format and will be matched with the CBCT data. Three highly radiopaque and relatively fixed positions in the teeth will be chosen as fiducially markers to match the STL files with the CBCT images in accordance with a best-fit algorithm using TRIOS software (3Shape).
- Finally, the fourth method for gingival biotype investigation will be performed by extraoral digital scanning (EDS) of a gypsum cast of the maxillary teeth, then the classic alginate impression of the max-illary arch and cast with dental stone will be made, gyp¬sum cast will be scanned using a three-dimen-sional scanner, and the STL data will be matched with the CBCT image according to a best-fit algorithm as in intraoral method.
- Assessment of some anatomic parameters (crown width/crown length ratio, attached gingival width, labial bone thickness and papilla volume) will also be performed.
- Conditions
- Periodontal Diseases
- Medical subject headings
- Periodontal Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
gingival biotype assessment by different methods.
will be assess by different methods measurement
- probe transparency (PT)
- transgingival probing (TP) , 3-cone-beam computed tomography (CBCT)
4-intraoral digital scanning (IDS) 5-extraoral digital scanning (EDS)
I will be measured according to De Rouck et al. :
- less than 1 mm thin-scalloped biotype'' (cluster A1): ''slender teeth, a narrow zone of keratinized tissue and a highly scalloped gingival margin
- more than 1 mm 'thick-flat biotype'' (cluster B): A clear thick gingiva was found in about two-thirds quadratic teeth, a broad zone of keratinized tissue and a flat gingival margin
- more than 1 mm (cluster A2): a clear thick gingiva with slender teeth, a narrow zone of keratinized tissue and a high gingival scallop
Measured: the outcome measure will be assessed and for which data will be reported up to 24 weeks"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2020
- Study start1 Nov 2020
- Primary completionJul 2021 (estimated)
- Study completionAug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies 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
- Ecologic or community
- Time perspective
- Other
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fahd Ayad Hammoodi Al-Janabi, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04640506
- Sponsor's protocol ID
- PER -3-3-1
- Status last verified
- Nov 2020
- First submitted
- 25 Sep 2020
- Last updated
- 24 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Assessing the Gingival Biotype in the Anterior Maxillary Area in Adult Patients, Using Different Measurement Methods.
- ClinicalTrials.gov ID
- NCT04640506
- Acronym / sponsor ID
- PER -3-3-1
- Conditions
- Periodontal Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- Jul 2021 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 23 Nov 2020 (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 study is a Diagnostic accuracy study that determining the accuracy of assessing the gingival biotype and some other anatomic parameters,including (crown width / crown length ratio, attached gingival width, labial bone thickness and papilla volume) by different methods :1- probe transparency, 2-transgingival probing, 3-cone beam computed tomography, 4-intraoral digital scanning, 5-extraoral digital scanning
Detailed description
- Patients will be recruited in periodontic department faculty of dentistry Cairo university.
- Patients who already need esthetic rehabilitation treatment (implant placement, restorative treatments, periodontal therapy, and root coverage) on anterior maxilla and this treatment needs to investigate the gingival biotype.
- Medical history will be taken.
- Oral examination will be done.
- Full mouth periodontal examination and charting will be done for each patient.
- The investigation will be explained to the patient.
- All the investigations will be carried out by one investigator.
- Dental patients will be received to the clinic (for esthetic rehabilitation treatment such as implant placement, restorative treatments, periodontal therapy, and root coverage on anterior maxilla).
- Patients who needs treatment will be investigated the gingival biotype by the five measurement methods (PT, TP, CBCT, IDS and EDS).
- Patients refusing to participate will be reported with the cause of their refusal.
- Conventional clinical examination will be held on a dental unit using the light of the unit, mirror and probe.
- Before the investigation, the aim of the study will be explained to the patient and the patient's acceptance to participate in the survey will be obtained.
- Periodontal status will be evaluated including assessment of gingival index (GI), plaque index (PI), probing pocket depth (PPD) on aesthetic zone in maxillary teeth by using UNC 15 periodontal probe which is 15mm long probe with markings at each millimetre and colour coded at 5th,10th and 15th mm.
- Then an investigator will evaluate the gingival biotype by probing Transparency (PT) as reported by (Kan et al., 2010). The periodontal probe will be softly inserted into the gingival sulcus till it reaches the sound bone on the labial side of the maxil¬lary anterior teeth and it will be parallel to the long axis of the crown. The gingival biotype will be considered as thick if the probe tip is not seen into the tissue and it will be considered as thin if the probe was seen. If the thick en d of the probe was seen into the tissue but the thin end was not, then it will be considered as a moderate biotype.
- The second method of assessment to the gingival biotype will be carried out using CBCT with lip retraction. It is important to note that the patients will not receive additional radiation exposure for the purpose of this investigation and to give us clear details about soft tissue, patients have already underwent CBCT examination as an investigation method for aesthetic rehabilitation treatment.
- Afterwards, gingival biotype assessment will be done by intraoral digital examination (Kim et al., 2016). This is the third method; the investigation of gingival biotype of the anterior maxilla will be done by means of a three-dimensional intraoral scanner. The intraoral scanning data will be acquired in stereolithogra¬phy (STL) format and will be matched with the CBCT data. Three highly radiopaque and relatively fixed positions in the teeth will be chosen as fiducially markers to match the STL files with the CBCT images in accordance with a best-fit algorithm using TRIOS software (3Shape).
- Finally, the fourth method for gingival biotype investigation will be performed by extraoral digital scanning (EDS) of a gypsum cast of the maxillary teeth, then the classic alginate impression of the max-illary arch and cast with dental stone will be made, gyp¬sum cast will be scanned using a three-dimen-sional scanner, and the STL data will be matched with the CBCT image according to a best-fit algorithm as in intraoral method.
- Assessment of some anatomic parameters (crown width/crown length ratio, attached gingival width, labial bone thickness and papilla volume) will also be performed.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Adult Egyptian dental patients receiving esthetic rehabilitation treatment (implant placement, restorative treatments, periodontal therapy, and root cov¬erage) on anterior maxilla at faculty of Dentistry, Cairo University.
Key inclusion criteria (5 listed)
- Male and female Patients whose age is between 18 to 40 years old.
- Health teeth only will be included.
- Patients who already need esthetic rehabilitation treatment (implant placement, restorative treatments, periodontal therapy, and root coverage) on anterior maxilla and this treatment needs to investigate the gingival biotype.
- An un-inflamed periodontal condition with a periodontal probing depth of no more than 3 mm, a bleeding index of < 2, and no gingival recession on maxillary anterior teeth.
- Provide informed consent.
Key exclusion criteria (9 listed)
- Pregnant or lactating females.
- Restoration or crowns in the maxillary anterior dentition.
- Malocclusion.
- Use of any medication affecting the soft tissue.
- Cigarette smoking.
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
gingival biotype assessment by different methods.
Time frame: the outcome measure will be assessed and for which data will be reported up to 24 weeks"
will be assess by different methods measurement 1. probe transparency (PT) 2. transgingival probing (TP) , 3-cone-beam computed tomography (CBCT) 4-intraoral digital scanning (IDS) 5-extraoral digital scanning (EDS) I will be measured according to De Rouck et al. : * less than 1 mm thin-scalloped biotype'' (cluster A1): ''slender teeth, a narrow zone of keratinized tissue and a highly scalloped gingival margin * more than 1 mm 'thick-flat biotype'' (cluster B): A clear thick gingiva was found in about two-thirds quadratic teeth, a broad zone of keratinized tissue and a flat gingival margin * more than 1 mm (cluster A2): a clear thick gingiva with slender teeth, a narrow zone of keratinized tissue and a high gingival scallop
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2020.
- Individual participant dataSharing planned: No
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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.
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 Periodontal Diseases, run by Cairo 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 5 inclusion and 9 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 24 Nov 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
gingival biotype assessment by different methods. (time frame: the outcome measure will be assessed and for which data will be reported up to 24 weeks"). 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 24 Nov 2020.