Jumping Gap Dimension at Maxillary TeethNCT04636385
Jumping Gap Dimension at Maxillary Teeth: Cone-Beam Computed Tomography (CBCT) Study
An observational study of Jumping Gap Dimension at Maxillary Teeth, run by Cairo University at 1 site in Egypt.
Trial summary
To assess the important anatomical structures involved in the treatment planning of immediate implants, particularly the jumping gap distance at the different maxillary teeth in the esthetic zone using CBCT analysis. Read more about this study
- Who is it for?
- Ages 15 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Jumping Gap Dimension at Maxillary Teeth
- How many people
- 253 participants
- Where
- 1 siteEgypt
- Study dates
- 14 Mar 2019to 10 Jul 2020
- 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 15 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Egyptian Population (Cairo Residents)
Who may be able to join
- teeth at upper jaw including : incisors, laterals, canines and premolars
Who cannot join
- teeth having: extensive restorations, crowns, implants
- CBCT scans showing scattering
- teeth showing bone loss around them indicative of periodontal disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Jumping Gap Dimension at Maxillary Teeth in Addition to Selected Anatomical Landmarks Related to Immediate Implant Placement in the Esthetic Zone: Observational Cone-Beam Computed Tomography (CBCT) Study.
To assess the important anatomical structures involved in the treatment planning of immediate implants, particularly the jumping gap distance at the different maxillary teeth in the esthetic zone using CBCT analysis. Additional relevant radiographic aspects are evaluated as well to aid in decision making related to immediate implants.
- Conditions
- Jumping Gap Dimension at Maxillary Teeth
- Being tested
- Observational study no intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational study no interventionOther
No intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Jumping gap
Estimation of the jumping gap dimension at maxillary anterior and premolar teeth at different apico-coronal levels through CBCT analysis by linear measurements in mm.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2020
- Study start14 Mar 2019
- Primary completion15 Apr 2020
- Study completion10 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Jumping Gap Dimension at Maxillary TeethStudies 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
- 253 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suzy Nabil Naiem, Cairo University
- Investigators
- Hani El Nahass, PhD, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04636385
- Sponsor's protocol ID
- 12 Nov 2020 Protocol
- Status last verified
- Nov 2020
- First submitted
- 9 Nov 2020
- Last updated
- 19 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It has not yet been decided between the study participants
Publications
Araujo MG, Sukekava F, Wennstrom JL, Lindhe J. Ridge alterations following implant placement in fresh extraction sockets: an experimental study in the dog. J Clin Periodontol. 2005 Jun;32(6):645-52. doi: 10.1111/j.1600-051X.2005.00726.x.
PubMed 15882225Botticelli D, Berglundh T, Lindhe J. Hard-tissue alterations following immediate implant placement in extraction sites. J Clin Periodontol. 2004 Oct;31(10):820-8. doi: 10.1111/j.1600-051X.2004.00565.x.
PubMed 15367183Lee SL, Kim HJ, Son MK, Chung CH. Anthropometric analysis of maxillary anterior buccal bone of Korean adults using cone-beam CT. J Adv Prosthodont. 2010 Sep;2(3):92-6. doi: 10.4047/jap.2010.2.3.92. Epub 2010 Sep 30.
PubMed 21165276
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Jumping Gap Dimension at Maxillary Teeth in Addition to Selected Anatomical Landmarks Related to Immediate Implant Placement in the Esthetic Zone: Observational Cone-Beam Computed Tomography (CBCT) Study.
- ClinicalTrials.gov ID
- NCT04636385
- Acronym / sponsor ID
- 12 Nov 2020 Protocol
- Conditions
- Jumping Gap Dimension at Maxillary Teeth
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 253 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 14 Mar 2019 (actual)
- Primary completion
- 15 Apr 2020 (actual)
- Study completion
- 10 Jul 2020 (actual)
- First posted
- 19 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.
To assess the important anatomical structures involved in the treatment planning of immediate implants, particularly the jumping gap distance at the different maxillary teeth in the esthetic zone using CBCT analysis. Additional relevant radiographic aspects are evaluated as well to aid in decision making related to immediate implants.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 15 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Egyptian Population (Cairo Residents)
Key inclusion criteria (1 listed)
- teeth at upper jaw including : incisors, laterals, canines and premolars
Key exclusion criteria (3 listed)
- teeth having: extensive restorations, crowns, implants
- CBCT scans showing scattering
- teeth showing bone loss around them indicative of periodontal disease
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 |
|---|---|---|
| Observational study no interventionNo intervention | Other | – |
Primary outcome
Jumping gap
Time frame: 1 month
Estimation of the jumping gap dimension at maxillary anterior and premolar teeth at different apico-coronal levels through CBCT analysis by linear measurements in mm.
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 19 Nov 2020.
- Background: PubMed 15882225Araujo MG, Sukekava F, Wennstrom JL, Lindhe J. Ridge alterations following implant placement in fresh extraction sockets: an experimental study in the dog. J Clin Periodontol. 2005 Jun;32(6):645-52. doi: 10.1111/j.1600-051X.2005.00726.x.
- Background: PubMed 15367183Botticelli D, Berglundh T, Lindhe J. Hard-tissue alterations following immediate implant placement in extraction sites. J Clin Periodontol. 2004 Oct;31(10):820-8. doi: 10.1111/j.1600-051X.2004.00565.x.
- Background: PubMed 21165276Lee SL, Kim HJ, Son MK, Chung CH. Anthropometric analysis of maxillary anterior buccal bone of Korean adults using cone-beam CT. J Adv Prosthodont. 2010 Sep;2(3):92-6. doi: 10.4047/jap.2010.2.3.92. Epub 2010 Sep 30.
- Individual participant dataSharing planned: Undecided. It has not yet been decided between the study participants
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.
Hani El Nahass, PhD study director
Cairo University
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 Jumping Gap Dimension at Maxillary Teeth, 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 1 inclusion and 3 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 19 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?
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?
Jumping gap (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04636385, which also lists 3 linked publications.
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 19 Nov 2020.