AmeloblastomaNCT06759610
Effect of Tetracycline Socked Pack on Acceleration of Healing During Marsupialization
A study testing Tetracyclin in people with Ameloblastoma, run by Minia University at 1 site in Egypt.
Trial summary
Ameloblastoma is an epithelial odontogenic tumor. Although ameloblastoma is classified as a benign tumor, it is locally invasive with high recurrence rate. It accounts for up to 18 % of all oral and odontogenic tumors. Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Ameloblastoma
- What is being tested?
- Tetracyclin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Feb 2024to 10 Aug 2024
- 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 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients (class I category according to American society of anesthesiologists) over 20 years and under 40 years of age, of either gender who are seeking treatment of a painful intra-body mandibular swelling cystic lesions 3 x 4 cm in size with biopsy conformation that the lesion is a Uni-cystic ameloblastoma
Who cannot join
- any systemic disease that interferes with bone healing,
- patients with significant medical condition,
- alcoholic individuals,
- patients on drugs that affect the central nervous systems,
- patients who reported pregnancy, lactation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Tetracycline Socked Pack on Acceleration of Healing During Marsupialization as a Primary Treatment for Locally Invasive Lesion: Single Blinded Randomized Clinical Trial
Ameloblastoma is an epithelial odontogenic tumor. Although ameloblastoma is classified as a benign tumor, it is locally invasive with high recurrence rate. It accounts for up to 18 % of all oral and odontogenic tumors.
Tetracyclines discovered in 1940s show activity against a wide variety of microorganisms including both Gram-positive and Gram-negative bacteria. Chlamydia, rickettsia, mycoplasmas, and protozoan parasites are also under its spectrum. Mechanism of action of tetracyclines is that it inhibits protein synthesis in bacteria by preventing the association of aminoacyl-tRNA with bacterial ribosome.
Read the detailed description
Ameloblastoma can be described as a silent lesion, as it grows slowly and usually becomes symptomatic when it reaches a large size. Unicystic ameloblastoma (UA) accounts for about 5 % to 15 % of all ameloblastoma, with reported recurrence rates 10 % to 25%. More than 90 % of unicystic ameloblastoma involve the mandible, mostly the posterior region.
Unicystic ameloblastoma (UA) refers to those lesions that show clinical and radiographic features of an odontogenic cyst but on histological examination show an ameloblastic proliferation into the cystic lumen, confined to the cyst lining, or invade the cystic wall, hence their name are intraluminar, luminar, or mural unicystic ameloblastoma (UA), respectively.
As UA less aggressive and has low recurrence rate than conventional type, conservative approaches have been widely used for treatment of UA such as marsupialization, marsupialization followed by enucleation, or enucleation alone or with adjunctive modalities as bone curettage, or application of liquid nitrogen or carnoy's solution.
Despite progress in reconstructive surgery, extensive jaw resection influences quality of life and causes numerous complications. For this cause particularly, conservative treatment of unicystic ameloblastoma in young patients should be superior choice over other treatment methods. Marsupialization by simple definition, is the creation of a pouch surgically, by removing part of the overlying mucoperiosteoum and accompanying cyst wall; followed by suturing of the incised mucosa with the border of the remaining cyst wall that has been leaved.The reduced tension gives rise to healing and formation of bone with the surrounding bone.
Matrix metalloproteinases (MMPs) are a group of Zn-dependent enzymes which regulate inflammation. Pathologically, the elevation of MMPs causes connective tissue and bone loss in various inflammatory diseases. Tetracyclines are effective inhibitors of mammalian MMPs. Tetracyclines can inhibit both intracellular and extracellular MMPs. Tetracycline inhibits MMPs on specific sites that have been identified as the calcium and zinc-binding site at C-11 and 12.
The anti-inflammatory nature of tetracycline is utilized in the various dermatological diseases and in periodontitis too. The anti-inflammatory property of tetracyclines can be useful in the reduction of postoperative sequalae following extraction.
- Conditions
- Ameloblastoma
- Being tested
- Tetracyclin
- Medical subject headings
- Ameloblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TetracyclinDrug
Also called marsupialization procedure
to evaluate the effect of tetracycline socked pack on acceleration of healing during marsupialization as a primary treatment for locally invasive lesions.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | About 7 patients who will be subjected to marsupialization procedure with a tetracycline socked pack during marsupialization Receives: Drug: Tetracyclin |
| Group B | Active comparator | About 7 patients who will undergo conventional marsupialization procedure Receives: Drug: Tetracyclin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic assessment CBCT
Radiographic assessment evaluate healing process CBCT (Planmeca Promax 3DMid machine, Helsinki Finland) scan will be obtained immediately post-operative ,3 and 6 months postoperative
Measured: From baseline to 3 and 6 months after the operation day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2025
- Study start10 Feb 2024
- Primary completion1 Aug 2024
- Study completion10 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmeloblastomaStudies of the same condition, open and under way.
- More trials run by Minia 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tarek Abdelbarry, Minia University
- Investigators
- TAREK ABDELBARY, Lecturer, Principal investigator, Faculty of Dentistry, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06759610
- Sponsor's protocol ID
- Tetracycline Socked Pack
- Status last verified
- Feb 2024
- First submitted
- 28 Dec 2024
- Last updated
- 6 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Tetracycline Socked Pack on Acceleration of Healing During Marsupialization as a Primary Treatment for Locally Invasive Lesion: Single Blinded Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06759610
- Acronym / sponsor ID
- Tetracycline Socked Pack
- Conditions
- Ameloblastoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 10 Feb 2024 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 10 Aug 2024 (actual)
- First posted
- 6 Jan 2025 (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.
Ameloblastoma is an epithelial odontogenic tumor. Although ameloblastoma is classified as a benign tumor, it is locally invasive with high recurrence rate. It accounts for up to 18 % of all oral and odontogenic tumors.
Tetracyclines discovered in 1940s show activity against a wide variety of microorganisms including both Gram-positive and Gram-negative bacteria. Chlamydia, rickettsia, mycoplasmas, and protozoan parasites are also under its spectrum. Mechanism of action of tetracyclines is that it inhibits protein synthesis in bacteria by preventing the association of aminoacyl-tRNA with bacterial ribosome.
Detailed description
Ameloblastoma can be described as a silent lesion, as it grows slowly and usually becomes symptomatic when it reaches a large size. Unicystic ameloblastoma (UA) accounts for about 5 % to 15 % of all ameloblastoma, with reported recurrence rates 10 % to 25%. More than 90 % of unicystic ameloblastoma involve the mandible, mostly the posterior region.
Unicystic ameloblastoma (UA) refers to those lesions that show clinical and radiographic features of an odontogenic cyst but on histological examination show an ameloblastic proliferation into the cystic lumen, confined to the cyst lining, or invade the cystic wall, hence their name are intraluminar, luminar, or mural unicystic ameloblastoma (UA), respectively.
As UA less aggressive and has low recurrence rate than conventional type, conservative approaches have been widely used for treatment of UA such as marsupialization, marsupialization followed by enucleation, or enucleation alone or with adjunctive modalities as bone curettage, or application of liquid nitrogen or carnoy's solution.
Despite progress in reconstructive surgery, extensive jaw resection influences quality of life and causes numerous complications. For this cause particularly, conservative treatment of unicystic ameloblastoma in young patients should be superior choice over other treatment methods. Marsupialization by simple definition, is the creation of a pouch surgically, by removing part of the overlying mucoperiosteoum and accompanying cyst wall; followed by suturing of the incised mucosa with the border of the remaining cyst wall that has been leaved.The reduced tension gives rise to healing and formation of bone with the surrounding bone.
Matrix metalloproteinases (MMPs) are a group of Zn-dependent enzymes which regulate inflammation. Pathologically, the elevation of MMPs causes connective tissue and bone loss in various inflammatory diseases. Tetracyclines are effective inhibitors of mammalian MMPs. Tetracyclines can inhibit both intracellular and extracellular MMPs. Tetracycline inhibits MMPs on specific sites that have been identified as the calcium and zinc-binding site at C-11 and 12.
The anti-inflammatory nature of tetracycline is utilized in the various dermatological diseases and in periodontitis too. The anti-inflammatory property of tetracyclines can be useful in the reduction of postoperative sequalae following extraction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: TetracyclinAbout 7 patients who will be subjected to marsupialization procedure with a tetracycline socked pack during marsupialization |
| Group B | Active comparator | Drug: TetracyclinAbout 7 patients who will undergo conventional marsupialization procedure |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- patients (class I category according to American society of anesthesiologists) over 20 years and under 40 years of age, of either gender who are seeking treatment of a painful intra-body mandibular swelling cystic lesions 3 x 4 cm in size with biopsy conformation that the lesion is a Uni-cystic ameloblastoma
Key exclusion criteria (5 listed)
- any systemic disease that interferes with bone healing,
- patients with significant medical condition,
- alcoholic individuals,
- patients on drugs that affect the central nervous systems,
- patients who reported pregnancy, lactation.
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 |
|---|---|---|
| TetracyclinAlso: marsupialization procedureto evaluate the effect of tetracycline socked pack on acceleration of healing during marsupialization as a primary treatment for locally invasive lesions. | Drug | Group A, Group B |
Primary outcome
Radiographic assessment CBCT
Time frame: From baseline to 3 and 6 months after the operation day
Radiographic assessment evaluate healing process CBCT (Planmeca Promax 3DMid machine, Helsinki Finland) scan will be obtained immediately post-operative ,3 and 6 months postoperative
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 6 Jan 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Ameloblastoma
Recruiting
Virtual Lesion Segmentation and Mandibular Ameloblastoma Radiographic Safety Margin
Ameloblastoma
Not yet recruitingPhase 2/3
Neoadjuvant Therapy With Conservative Surgery vs. Up-front Conservative Surgery for BRAF V600E-Mutated Ameloblastoma
Ameloblastoma
RecruitingPhase 2
Clinical Study of Neoadjuvant Targeted Therapy for Ameloblastoma
Ameloblastoma, BRAF V600E Mutation Positive
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.
TAREK ABDELBARY, Lecturer principal investigator
Faculty of Dentistry, Minia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tetracyclin in people with Ameloblastoma, run by Minia 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 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: finished, as of the sponsor's last update on 6 Jan 2025. 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?
Radiographic assessment CBCT (time frame: From baseline to 3 and 6 months after the operation day). 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 Jan 2025.