Odontogenic TumorsNCT05329974
Computer Guided Buccal Cortical Plate Separation for Removal of Calcified Benign Odontogenic Tumors Affecting Mandibular Angle Region
A study testing Computer guided buccal cortical plate separation in people with Odontogenic Tumors and Odontoma, run by Cairo University at 2 sites in Egypt.
Trial summary
Computer guided buccal cortical plate separation was performed for ten patients using patient specific osteotomy locating guides and pre-bent plates. The guide was designed to outline the osteotomy, buccal cortical plate was separated, the lesion was removed, finally the pre-bent plates were used to fix the separated… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Odontogenic Tumors, Odontoma
- What is being tested?
- Computer guided buccal cortical plate separation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Apr 2018to 30 Jul 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients with well-defined radiopaque lesion affecting angle region, its conventional removal may compromise the bone continuity and leads to pathological fracture indicating the need of buccal cortical plate separation technique
Who cannot join
- Patients with any medical condition contraindicating the surgical procedures were excluded
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Faculty of dentistry, Cairo university
Cairo, 11728
Faculty of Dentistry
Cairo
About this study
Computer guided buccal cortical plate separation was performed for ten patients using patient specific osteotomy locating guides and pre-bent plates. The guide was designed to outline the osteotomy, buccal cortical plate was separated, the lesion was removed, finally the pre-bent plates were used to fix the separated cortex.
Read the detailed description
Computer guided buccal cortical plate separation was performed for ten patients using patient specific osteotomy locating guides and pre-bent plates. The guide was designed to outline the osteotomy, buccal cortical plate was separated, the lesion was removed, finally the pre-bent plates were used to fix the separated cortex.
- Conditions
- Odontogenic Tumors, Odontoma
- Being tested
- Computer guided buccal cortical plate separation
- Medical subject headings
- Odontogenic Tumors, Odontoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer guided buccal cortical plate separationOther
Computer guided buccal cortical plate separation for removal of calcified benign odontogenic tumors
| Study group | Role | What they receive |
|---|---|---|
| Computer guided buccal cortical plate separation | Experimental | Computer guided buccal cortical plate separation for removal of calcified benign odontogenic tumors Receives: Other: Computer guided buccal cortical plate separation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra-operative time
Intra-operative time was measured from the start of the incision till suturing
Measured: during the surgery
Secondary outcomes (2)
Postoperative pain
Postoperative pain using 0 - 10 visual analog scale
Measured: 2, 5, and 10 days after the surgery
Edema
Edema was assessed using a four grades scale: Grade 0, No edema; Grade 1, mild edema (just visible); Grade 2; moderate edema (local); Grade 3, severe edema (extended).
Measured: 5 and 10 days after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2022
- Study start1 Apr 2018
- Primary completion30 Jul 2021
- Study completion30 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Odontogenic TumorsStudies 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, Sherif Ali, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05329974
- Sponsor's protocol ID
- OMFS-11021
- Status last verified
- Apr 2022
- First submitted
- 6 Apr 2022
- Last updated
- 15 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Omara M, Gouda A, Ali S. Computer-guided buccal cortical plate separation for removal of calcified benign odontogenic tumors affecting the mandibular angle region. Maxillofac Plast Reconstr Surg. 2022 Sep 22;44(1):30. doi: 10.1186/s40902-022-00354-6.
PubMed 36136180
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer Guided Buccal Cortical Plate Separation for Removal of Calcified Benign Odontogenic Tumors Affecting Mandibular Angle Region
- ClinicalTrials.gov ID
- NCT05329974
- Acronym / sponsor ID
- OMFS-11021
- Conditions
- Odontogenic Tumors, Odontoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 30 Jul 2021 (actual)
- Study completion
- 30 Jul 2021 (actual)
- First posted
- 15 Apr 2022 (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.
Computer guided buccal cortical plate separation was performed for ten patients using patient specific osteotomy locating guides and pre-bent plates. The guide was designed to outline the osteotomy, buccal cortical plate was separated, the lesion was removed, finally the pre-bent plates were used to fix the separated cortex.
Detailed description
Computer guided buccal cortical plate separation was performed for ten patients using patient specific osteotomy locating guides and pre-bent plates. The guide was designed to outline the osteotomy, buccal cortical plate was separated, the lesion was removed, finally the pre-bent plates were used to fix the separated cortex.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Computer guided buccal cortical plate separation | Experimental | Other: Computer guided buccal cortical plate separationComputer guided buccal cortical plate separation for removal of calcified benign odontogenic tumors |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with well-defined radiopaque lesion affecting angle region, its conventional removal may compromise the bone continuity and leads to pathological fracture indicating the need of buccal cortical plate separation technique
Key exclusion criteria (1 listed)
- Patients with any medical condition contraindicating the surgical procedures were excluded
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 |
|---|---|---|
| Computer guided buccal cortical plate separationComputer guided buccal cortical plate separation for removal of calcified benign odontogenic tumors | Other | Computer guided buccal cortical plate separation |
Primary outcome
Intra-operative time
Time frame: during the surgery
Intra-operative time was measured from the start of the incision till suturing
2 secondary outcomes
Postoperative pain
Time frame: 2, 5, and 10 days after the surgery
Edema
Time frame: 5 and 10 days after the surgery
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 15 Apr 2022.
- Derived from this study: PubMed 36136180Omara M, Gouda A, Ali S. Computer-guided buccal cortical plate separation for removal of calcified benign odontogenic tumors affecting the mandibular angle region. Maxillofac Plast Reconstr Surg. 2022 Sep 22;44(1):30. doi: 10.1186/s40902-022-00354-6.
Related trials for Odontogenic Tumors
Not yet recruiting
Osteogenic Potential of Topical Metformin Gel on Cystic Jaw Defects
Jaw Cysts, Metformin
Recruiting
Effect of Photobiomodulation on Pain and Healing of the Vertical Releasing Incision After Endodontic Microsurgery
Apical Periodontitis, Endodontically Treated Teeth
Active, not recruiting
Bone Defects Reconstruction After Dentigerous Cyst Enucleation With Autogenous Demineralized Dentin Matrix- ADDM and Advanced Platelet-Rich Fibrin- A-PRF.
Impact Molar, Mandible Cyst
RecruitingObservational study
Familial Investigations of Childhood Cancer Predisposition
Acute Leukemia, Adenomatous Polyposis
Active, not recruitingPhase 2
Nivolumab and Ipilimumab in Treating Patients With Rare Tumors
Acinar Cell Carcinoma, Adenoid Cystic Carcinoma
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computer guided buccal cortical plate separation in people with Odontogenic Tumors and Odontoma, run by Cairo University at 2 sites 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 1 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 15 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Intra-operative time (time frame: during the surgery). 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 NCT05329974, which also lists 1 linked publication.
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 15 Apr 2022.