Computer GuidedNCT05002283
Accuracy of Computer Guided Free Gingival Graft
A study testing patient specific guide in people with Computer Guided and Free Gingival Graft, run by Cairo University at 1 site in Egypt.
Trial summary
A patient specific surgical guide for harvesting of free gingival graft from the palate Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Computer Guided, Free Gingival Graft
- What is being tested?
- patient specific guide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2020to 1 Aug 2021
- Phase
- Interventional
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- patients with intraoral alveolar defect requiring soft tissue augmentation
Who cannot join
- - patients with systemic diseases interfering with surgical interventions
- - Poor oral hygiene
Trial locations and contacts
1 site in 1 country.
About this study
A patient specific surgical guide for harvesting of free gingival graft from the palate
- Conditions
- Computer Guided, Free Gingival Graft
- Being tested
- patient specific guide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patient specific guideOther
harvesting palatal free gingival graft using the patient specific guide
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | the patients undergo free gingival graft harvest from the palate using a patient specific guide Receives: Other: patient specific guide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of the guide
accuracy of the predefined graft dimensions relative to the required dimensions of the recipient site in millimetres
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2021
- Study start1 Aug 2020
- Primary completion31 Jul 2021
- Study completion1 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Computer GuidedStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Shawky, Cairo University
- Investigators
- Mohamed Shawky, MSc, Principal investigator, Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05002283
- Sponsor's protocol ID
- OMFS 3-3-5
- Status last verified
- Aug 2021
- First submitted
- 1 Aug 2021
- Last updated
- 12 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: the IPD will be made available upon request from the author
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Computer Guided Free Gingival Graft
- ClinicalTrials.gov ID
- NCT05002283
- Acronym / sponsor ID
- OMFS 3-3-5
- Conditions
- Computer Guided, Free Gingival Graft
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 12 Aug 2021 (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.
A patient specific surgical guide for harvesting of free gingival graft from the palate
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Other: patient specific guidethe patients undergo free gingival graft harvest from the palate using a patient specific guide |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- patients with intraoral alveolar defect requiring soft tissue augmentation
Key exclusion criteria (2 listed)
- - patients with systemic diseases interfering with surgical interventions
- - Poor oral hygiene
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 |
|---|---|---|
| patient specific guideharvesting palatal free gingival graft using the patient specific guide | Other | Study group |
Primary outcome
Accuracy of the guide
Time frame: One month
accuracy of the predefined graft dimensions relative to the required dimensions of the recipient site in millimetres
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 12 Aug 2021.
- Individual participant dataSharing planned: No. the IPD will be made available upon request from the author
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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.
Mohamed Shawky, MSc principal investigator
Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing patient specific guide in people with Computer Guided and Free Gingival Graft, 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 2 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 12 Aug 2021. 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?
Accuracy of the guide (time frame: One month). 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 12 Aug 2021.