Abnormal Jaw RelationsNCT03493477
Evaluation of Gingival Biotypes of Anterior Teeth in Adults With Abnormal Skeletal Jaw Relations
An observational study of Abnormal Jaw Relations, run by Cairo University.
Trial summary
The aim of this study is to evaluate gingival biotypes and width of keratinized gingiva in the anterior region of adults with abnormal skeletal jaw relations. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Abnormal Jaw Relations
- What is being tested?
- exposure will be abnormal skeletal jaw relations
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2018to 30 Oct 2018
- 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 30 years
- All sexes
- Adult
Study population: Patients attending the orthodontic clinic in the orthodontic department, Faculty of Dentistry, Cairo University , who have either skeletal class II or class III maxillo-mandibular jaw relations
Who may be able to join
- Adult patients having an age range of 18 -30 years.
- Adults with skeletal Class II and Class III jaw relation
- Fair oral hygiene with absence of any active periodontal disease.
- Patients with full permanent dentition (with the exception of third molars) with acceptable alignment of teeth.
- Absence of systemic disease (medically free patients).
Who cannot join
- Patients with extensive restorations on the anterior teeth.
- Subjects taking medication affecting the periodontal tissues
- History of previous periodontal surgery or orthodontic treatment.
- Pregnant or lactating female patients
- Syndromic patients
About this study
Official title: Evaluation of Gingival Biotypes and Width of Keratinized Gingiva of Anterior Teeth in Adults With Abnormal Skeletal Jaw Relations: A Cross-sectional Study
The aim of this study is to evaluate gingival biotypes and width of keratinized gingiva in the anterior region of adults with abnormal skeletal jaw relations.
Read the detailed description
This study will include consecutive adult patients seeking orthodontic treatment with skeletal Class II and Class III jaw relations based on clinical and cephalometric values. Each group will be further divided according to their vertical skeletal pattern. Gingival biotype will be determined -using the probe transparency method- into either thick or thin biotype for all anterior teeth in both jaws. Width of keratinized gingiva will be measured from the muco-gingival junction to the free gingival margin in the middle of the crown of the maxillary and mandibular anterior teeth using a digital caliper with a sensitivity of 0.01 mm. Statistical analysis will be applied to see the correlation between gingival biotypes , width of keratinized gingiva , and abnormal skeletal jaw relations.
- Conditions
- Abnormal Jaw Relations
- Being tested
- exposure will be abnormal skeletal jaw relations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exposure will be abnormal skeletal jaw relationsOther
Class II skeletal jaw relation or class III skeletal jaw relation based on lateral cephalometric radiograph
| Study group | Role | What they receive |
|---|---|---|
| Skeletal Class II Group | From the lateral cephalometric radiograph , Steiner analysis (ANB angle should be higher than mean value, mean value 3 ±2), Witt's appraisal should be higher than mean value (mean value zero), and McNamara analysis (A-B diff NV should be higher than mean value, mean value 4±2).At least two of the three mentioned analyses should verify skeletal class II relation Receives: Other: exposure will be abnormal skeletal jaw relations | |
| Skeletal Class III Group | From the lateral cephalometric radiograph , Steiner analysis (ANB angle should be lower than mean value, mean value 3 ±2), Witt's appraisal should be lower than mean value (mean value zero), and McNamara analysis (A-B diff NV should be lower than mean value, mean value 4±2).At least two of the three mentioned analyses should verify skeletal class III relation Receives: Other: exposure will be abnormal skeletal jaw relations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between gingival biotypes and abnormal sagittal skeletal jaw relations.
Gingival biotype will be determined using the probe transparency method, in which probing is done in the sulcus at the mid facial aspect of maxillary and mandibular incisors and canines by a periodontal probe. Gingival thickness will be classified as thin when the underlying periodontal probe outline can be seen through the gingiva; otherwise, it will be considered thick. Results of the twelve anterior teeth will be recorded for each patient in a tabulated form. Statistical Analysis will be done to detect the correlation between gingival biotypes (Thick or thin ) and abnormal sagittal skeletal jaw relation ( skeletal class II or skeletal class III 9
Measured: 6 months
Secondary outcomes (3)
Correlation between width of keratinized gingiva in the anterior region and abnormal sagittal skeletal jaw relation
Width of keratinized gingiva will be measured from the muco-gingival junction to the free gingival margin in the middle of the crown of the maxillary and mandibular anterior teeth using a digital caliper with a sensitivity of 0.01 mm. Statistical analysis will be done to detect the correlation between the width of keratinized gingiva and abnormal sagittal jaw relations (skeletal class II or skeletal class III )
Measured: 6 months
Correlation between gingival biotypes and abnormal vertical skeletal jaw relations.
will be determined using the probe transparency method, in which probing is done in the sulcus at the mid facial aspect of maxillary and mandibular incisors and canines by a periodontal probe. Gingival thickness will be classified as thin when the underlying periodontal probe outline can be seen through the gingiva; otherwise, it will be considered thick. Results of the twelve anterior teeth will be recorded for each patient in a tabulated form.Statistical analysis will be done to detect the correlation between the gingival biotype ( thick or thin ) and abnormal vertical skeletal jaw relations ( long face or short face )
Measured: 6 months
Correlation between width of keratinized gingiva and abnormal vertical skeletal jaw relations.
Width of keratinized gingiva will be measured from the muco-gingival junction to the free gingival margin in the middle of the crown of the maxillary and mandibular anterior teeth using a digital caliper with a sensitivity of 0.01 mm .Statistical analysis will be done to detect the correlation between the width of keratinized gingiva and abnormal vertical skeletal jaw relations ( long face or short face )
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2018
- Study start1 May 2018 (estimated)
- Primary completion30 Oct 2018 (estimated)
- Study completion30 Oct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abnormal Jaw RelationsStudies 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
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed magdy Mohamed Sabrah, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03493477
- Sponsor's protocol ID
- CEBD-CU-2018-03-20
- Status last verified
- Apr 2018
- First submitted
- 20 Mar 2018
- Last updated
- 10 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- 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 10 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Gingival Biotypes and Width of Keratinized Gingiva of Anterior Teeth in Adults With Abnormal Skeletal Jaw Relations: A Cross-sectional Study
- ClinicalTrials.gov ID
- NCT03493477
- Acronym / sponsor ID
- CEBD-CU-2018-03-20
- Conditions
- Abnormal Jaw Relations
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 May 2018 (estimated)
- Primary completion
- 30 Oct 2018 (estimated)
- Study completion
- 30 Oct 2018 (estimated)
- First posted
- 10 Apr 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.
The aim of this study is to evaluate gingival biotypes and width of keratinized gingiva in the anterior region of adults with abnormal skeletal jaw relations.
Detailed description
This study will include consecutive adult patients seeking orthodontic treatment with skeletal Class II and Class III jaw relations based on clinical and cephalometric values. Each group will be further divided according to their vertical skeletal pattern. Gingival biotype will be determined -using the probe transparency method- into either thick or thin biotype for all anterior teeth in both jaws. Width of keratinized gingiva will be measured from the muco-gingival junction to the free gingival margin in the middle of the crown of the maxillary and mandibular anterior teeth using a digital caliper with a sensitivity of 0.01 mm. Statistical analysis will be applied to see the correlation between gingival biotypes , width of keratinized gingiva , and abnormal skeletal jaw relations.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Skeletal Class II Group | – | Other: exposure will be abnormal skeletal jaw relationsFrom the lateral cephalometric radiograph , Steiner analysis (ANB angle should be higher than mean value, mean value 3 ±2), Witt's appraisal should be higher than mean value (mean value zero), and McNamara analysis (A-B diff NV should be higher than mean value, mean value 4±2).At least two of the three mentioned analyses should verify skeletal class II relation |
| Skeletal Class III Group | – | Other: exposure will be abnormal skeletal jaw relationsFrom the lateral cephalometric radiograph , Steiner analysis (ANB angle should be lower than mean value, mean value 3 ±2), Witt's appraisal should be lower than mean value (mean value zero), and McNamara analysis (A-B diff NV should be lower than mean value, mean value 4±2).At least two of the three mentioned analyses should verify skeletal class III relation |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Age groups
- Adult
- Study population
- Patients attending the orthodontic clinic in the orthodontic department, Faculty of Dentistry, Cairo University , who have either skeletal class II or class III maxillo-mandibular jaw relations
Key inclusion criteria (5 listed)
- Adult patients having an age range of 18 -30 years.
- Adults with skeletal Class II and Class III jaw relation
- Fair oral hygiene with absence of any active periodontal disease.
- Patients with full permanent dentition (with the exception of third molars) with acceptable alignment of teeth.
- Absence of systemic disease (medically free patients).
Key exclusion criteria (5 listed)
- Patients with extensive restorations on the anterior teeth.
- Subjects taking medication affecting the periodontal tissues
- History of previous periodontal surgery or orthodontic treatment.
- Pregnant or lactating female patients
- Syndromic patients
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 |
|---|---|---|
| exposure will be abnormal skeletal jaw relationsClass II skeletal jaw relation or class III skeletal jaw relation based on lateral cephalometric radiograph | Other | Skeletal Class II Group, Skeletal Class III Group |
Primary outcome
Correlation between gingival biotypes and abnormal sagittal skeletal jaw relations.
Time frame: 6 months
Gingival biotype will be determined using the probe transparency method, in which probing is done in the sulcus at the mid facial aspect of maxillary and mandibular incisors and canines by a periodontal probe. Gingival thickness will be classified as thin when the underlying periodontal probe outline can be seen through the gingiva; otherwise, it will be considered thick. Results of the twelve anterior teeth will be recorded for each patient in a tabulated form. Statistical Analysis will be done to detect the correlation between gingival biotypes (Thick or thin ) and abnormal sagittal skeletal jaw relation ( skeletal class II or skeletal class III 9
3 secondary outcomes
Correlation between width of keratinized gingiva in the anterior region and abnormal sagittal skeletal jaw relation
Time frame: 6 months
Correlation between gingival biotypes and abnormal vertical skeletal jaw relations.
Time frame: 6 months
Correlation between width of keratinized gingiva and abnormal vertical skeletal jaw relations.
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2018.
- Individual participant dataSharing planned: Yes
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 Abnormal Jaw Relations, 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 5 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 10 Apr 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?
Correlation between gingival biotypes and abnormal sagittal skeletal jaw relations. (time frame: 6 months). 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 10 Apr 2018.