Soft Tissue VolumeNCT06354374
Soft Tissue Volume, Dimensions and Tomographic Alveolar Ridge Classification System for Dental Implant Treatment.
An observational study of Soft Tissue Volume, run by Ain Shams University at 1 site in Egypt.
Trial summary
Despite the importance of soft tissue dimensions for periodontal, restorative, implant, and orthodontic treatment, the current classifications of tomographic alveolar ridge topography lack the soft tissue component(Tolstunov, 2014). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Soft Tissue Volume
- What is being tested?
- volume survey
- Type of treatment
- Pill or oral medicine
- How many people
- 350 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Feb 2024to Dec 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This cross sectional observational clinical study will include 350 patients that will be recruited from the outpatient clinic of the department of Oral Medicine, Periodontology, and Diagnosis, Faculty of Dentistry, The British University in Egypt. Demographic data of all patients will be collected. Patients will be clearly instructed about the purpose of this study and will give their consent by signing an informed consent. The study will be started after being accepted by the faculty of Dentistry, The British University in Egypt Research Ethics Committee. The study tracks the guidelines of the research ethical committee in line with the Helsinki Declaration of 1975.
Who may be able to join
- Adult patients in a healthy systemic condition who required comprehensive dental treatment.
- Both genders with age group > 18 years old.
- Patients should have at least a single missing tooth that requires dental implant placement.
- Healing period of 3 months after extraction prior to surgical procedures.
- CBCT scans will be obtained as a part of the comprehensive dental treatment.
- Patients should approve to deliver a signature to a written consent after studying nature explanation.
Who cannot join
- Patients with severe smoking habits >10 cig \ day.
- Pregnant females, decisional impaired individuals, Prisoners, and handicapped patients.
- Patients having poor oral hygiene or not wanting to carry out oral hygiene measures.
- Patients on any medication affecting the soft tissue health (e.g., amlodipine, Cyclosporine A, hydantoin)
- Patients with infections either periodontally or periapically
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ahmed Hamdy
Al Shorouk City, Cairo Governorate, 11837
Ahmed Hamdy, +201061112512, ahmed.esmaail@bue.edu.eg
About this study
Official title: Relationship Between Soft Tissue Volume, Dimensions and Tomographic Alveolar Ridge Classification System for Dental Implant Treatment.
Despite the importance of soft tissue dimensions for periodontal, restorative, implant, and orthodontic treatment, the current classifications of tomographic alveolar ridge topography lack the soft tissue component(Tolstunov, 2014). Therefore, the present study will be to evaluate the relationship between soft tissue volume and the dimensions \& tomographic alveolar ridge classes as well as to incorporate the soft tissue volumetric evaluation in the classification system.
- Conditions
- Soft Tissue Volume
- Being tested
- volume survey
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
volume surveyDiagnostic test
All subjects will receive oral hygiene instructions and, if needed. A dental cleaning of plaque and calculus. After calibration using digital photographs and digital intraoral scans, CBCT scans will be taken as a prerequisite for dental implant treatment protocol. one dentist who will not be involved in the screening phase will obtain all clinical parameters (gingival biotype, probing depth, gingival thickness, gingival width) to avoid any bias. After finishing data collection, a customized treatment plan for each patient will be performed and dental implant treatment will be completed for each patient.
What is being measured
The primary outcome is the main question the study is designed to answer.
the relationship between soft tissue volume & tomographic alveolar ridge classes
the relationship between soft tissue volume and tomographic alveolar ridge classes
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start22 Feb 2024
- Primary completionJul 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue VolumeStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Cross-sectional
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Collaborators
- British University In Egypt
- Responsible party
- Principal investigator, ahmed hamdy mahmoud, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06354374
- Sponsor's protocol ID
- 24-026
- Status last verified
- Aug 2024
- First submitted
- 31 Mar 2024
- Last updated
- 6 Aug 2024
- Results posted
- No
- 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 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Soft Tissue Volume, Dimensions and Tomographic Alveolar Ridge Classification System for Dental Implant Treatment.
- ClinicalTrials.gov ID
- NCT06354374
- Acronym / sponsor ID
- 24-026
- Conditions
- Soft Tissue Volume
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Collaborators
- British University In Egypt
- Study start
- 22 Feb 2024 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 9 Apr 2024 (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.
Despite the importance of soft tissue dimensions for periodontal, restorative, implant, and orthodontic treatment, the current classifications of tomographic alveolar ridge topography lack the soft tissue component(Tolstunov, 2014). Therefore, the present study will be to evaluate the relationship between soft tissue volume and the dimensions \& tomographic alveolar ridge classes as well as to incorporate the soft tissue volumetric evaluation in the classification system.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This cross sectional observational clinical study will include 350 patients that will be recruited from the outpatient clinic of the department of Oral Medicine, Periodontology, and Diagnosis, Faculty of Dentistry, The British University in Egypt. Demographic data of all patients will be collected. Patients will be clearly instructed about the purpose of this study and will give their consent by signing an informed consent. The study will be started after being accepted by the faculty of Dentistry, The British University in Egypt Research Ethics Committee. The study tracks the guidelines of the research ethical committee in line with the Helsinki Declaration of 1975.
Key inclusion criteria (6 listed)
- Adult patients in a healthy systemic condition who required comprehensive dental treatment.
- Both genders with age group > 18 years old.
- Patients should have at least a single missing tooth that requires dental implant placement.
- Healing period of 3 months after extraction prior to surgical procedures.
- CBCT scans will be obtained as a part of the comprehensive dental treatment.
Key exclusion criteria (5 listed)
- Patients with severe smoking habits >10 cig \ day.
- Pregnant females, decisional impaired individuals, Prisoners, and handicapped patients.
- Patients having poor oral hygiene or not wanting to carry out oral hygiene measures.
- Patients on any medication affecting the soft tissue health (e.g., amlodipine, Cyclosporine A, hydantoin)
- Patients with infections either periodontally or periapically
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 |
|---|---|---|
| volume surveyAll subjects will receive oral hygiene instructions and, if needed. A dental cleaning of plaque and calculus. After calibration using digital photographs and digital intraoral scans, CBCT scans will be taken as a prerequisite for dental implant treatment protocol. one dentist who will not be involved in the screening phase will obtain all clinical parameters (gingival biotype, probing depth, gingival thickness, gingival width) to avoid any bias. After finishing data collection, a customized treatment plan for each patient will be performed and dental implant treatment will be completed for each patient. | Diagnostic test | – |
Primary outcome
the relationship between soft tissue volume & tomographic alveolar ridge classes
Time frame: 3 months
the relationship between soft tissue volume and tomographic alveolar ridge classes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- Individual participant dataSharing planned: Undecided
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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 Soft Tissue Volume, run by Ain Shams 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: status not confirmed, as of the sponsor's last update on 6 Aug 2024. 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?
the relationship between soft tissue volume & tomographic alveolar ridge classes (time frame: 3 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 6 Aug 2024; AzTrials last refreshed its copy on 1 Nov 2026.