Maxillary CystNCT06749158
Radiographic and Histological Assessment of GBR Using DBB Compared to Spontaneous Bone Regeneration of Maxillary Defects , Resulted From Enucleation of Intra-bony Cystic Lesions
A study testing spontaneous bone regeneration and guided bone regeneration in people with Maxillary Cyst, run by Cairo University at 1 site in Egypt.
Trial summary
Two groups of patients with maxillary defects resulted from enucleation of intra-bony cystic lesions the 1st group will be subjected to guided bone regeneration while the second group will be subjected to spontaneous bone regeneration. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Maxillary Cyst
- What is being tested?
- spontaneous bone regeneration and guided bone regeneration
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Dec 2024to 1 Feb 2026
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Presence of a well-defined pathological cystic lesion involving the maxilla, confirmed clinically and radiographically that require surgical enucleation resulting in an intra-bony defect.
- Mesiodistal dimension of the defect ranging from 1 cm to 4.0 cm.
- Patients aged 20 to 50 years, of either sex.
- Patients medically fit for surgical intervention under local or general anesthesia (ASA I or II)
- Absence of systemic conditions affecting bone healing (e.g., uncontrolled diabetes, osteoporosis)
- Patients willing to participate in the study and able to provide informed written consent.
- Availability of adequate postoperative follow-up (minimum of 6 months).
Who cannot join
- Pregnant or lactating women.
- Radiographically, Presence of multi-locular or aggressive lesions suggestive of odontogenic tumors (e.g., ameloblastoma)
- Patients with compromised immune status (e.g., HIV, long-term corticosteroid therapy)
- History of allergic reaction to any of the surgical materials used (e.g., titanium, bovine bone graft).
- Patients participating in another clinical trial or receiving investigational therapy during the study period.
- Presence of acute infection at the surgical site.
- cysts with a known high recurrence rate such as Odontogenic keratocysts (OKC).
Trial locations and contacts
1 site in 1 country.
Egypt1 site
faculty of oral and dental medicine, Cairo university
Cairo, Giza Governorate, 12613
About this study
Official title: Radiographic and Histological Assessment of Guided Bone Regeneration Using Deproteinized Bovine Bone Compared to Spontaneous Bone Regeneration of Maxillary Defects , Resulted From Enucleation of Intra-bony Cystic Lesions : Randomized Control Clinical Trial
Two groups of patients with maxillary defects resulted from enucleation of intra-bony cystic lesions the 1st group will be subjected to guided bone regeneration while the second group will be subjected to spontaneous bone regeneration.
Read the detailed description
- Two groups of patients with maxillary cystic lesions indicated for enucleation. One will be subjected to guided bone regeneration while the other will be subjected to spontaneous bone regeneration.
- General pre-operative procedures:
- All patients will undergo appropriate preparation involving periodontal therapy , proper oral hygiene measures in addition to endodontic treatment for the non-vital teeth related to the lesion. intraoperative procedure: (both groups)
- Scrubbing and draping of the patient will be carried out in a standard fashion using betadine surgical scrub.
- Local anesthesia will be administered (Articaine hydrochloride 4% with Epinephrine 1:100,000) injectable solution.
- Flap design: a sulcular incision will be done , extending two teeth beyond the area of interest followed by two oblique incisions on either side of the flap. A full thickness mucoperiosteal flap will be raised to expose the area occupied by the lesion.
- After flap reflection, the exposed bone related to the lesion will need to be removed to provide adequate accessibility before enucleation of the lesion.
- The specimens will be fixed in 10% formalin for pathological examination.
Intra-operative procedures - continued in first Group (GBR group) The intra-bony defect will be filled with Deproteinized Bovine Bone. In Both groups: Titanium mesh will be tailored with 3mm overlap at the edges to cover the bone window completely and fixed to the bone using mono-cortical titanium screws.
This is followed by Primary closure using 4-0 vicryl sutures that will be removed 10 days postoperatively.
Postoperative medications:
For both groups, postoperative antibiotic course of amoxicillin+ clavulanic acid 1 g tab (Augmentin) will be prescribed for one week and isobutylphenylpropionic acid 600 mg tab (Brufen) twice daily for one week. One shot of dexamethasone 8 mg vial will be administered intramuscularly immediately after the surgery together with ketorolac tromethamine 30 mg .
Postoperative care and instructions:
- Cold compresses will be applied for 10 minutes every 30 minutes for the first 24 hours postoperatively replaced by warm fomentation with the same rate for the next two days.
- Patients will be advised to maintain good oral hygiene and oral hygiene rinses using 2% chlorohexidine gluconate mouth rinse for a week starting from the second postoperative day (three times daily)
- Soft diet is recommended for the first 48 hours.
- The patients will be recalled after two days, after one week, at the end of the first month and then at three and six months to monitor the soft tissue healing where the sutures were removed after 10 days , then at the sixth months to evaluate the bony healing.
Radiographic assessment will be achieved by CBCT scan preoperatively, immediately postoperative ,and 6 months postoperatively to evaluate the change in the bone density . A total of three scans will be taken for each patient.
In the second group, the amount and percentage of bone gain will be measured based on the CBCT scans .
in the 6 months after the surgery ,titanium mesh and the screws will be removed and core biopsy will be taken for histological assessment.
dental implant/s will be placed in cases indicated for implantation.
- Conditions
- Maxillary Cyst
- Being tested
- spontaneous bone regeneration, guided bone regeneration
- Keywords
- Guided bone regeneration, Spontaneous bone regeneration, cyst enucleation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spontaneous bone regenerationProcedure or surgery
stage 1 surgery:
- after administration of Local anesthesia (Articaine hydrochloride 4% with Epinephrine 1:100,000 injectable solution), sulcular incision will be done , extending two teeth beyond the area of interest followed by two oblique incisions on either side of the flap
- after flap elevation, enucleation of the cystic lesion and extraction of the non-restorable teeth related to the lesion will be done.
- titanium mesh will be tailored with 3 mm overlap at the edges to cover the bone window completely and fixed to the bone using mono-cortical titanium screws.
This will be followed by:
Primary closure using 4-0 vicryl sutures that will be removed 10 days postoperatively.
stage 2 surgery(after 6 months):
- titanium mesh and screws will be removed.
- core biopsy will be obtained for histological assessment
- dental implant/s placement for cases indicated for implantation.
guided bone regenerationProcedure or surgery
stage 1 surgery after cyst enucleation and extraction of the non-restorable teeth related to the lesion, The intra-bony defect will be filled with Deproteinized Bovine Bone.
-Titanium mesh will be tailored with 3mm overlap at the edges to cover the bone window completely and fixed to the bone using mono-cortical titanium screws. This will be followed by Primary closure using 4-0 vicryl sutures that will be removed 10 days postoperatively.
stage 2 surgery(6 months later) :
- titanium mesh will be removed.
- core biopsy will be obtained for histological assessment.
- dental implant/s placement for cases indicated for implantation.
| Study group | Role | What they receive |
|---|---|---|
| spontaneous bone regeneration | Active comparator | after cyst enucleation, the intra-bony defect will be covered by Titanium mesh that is fixed by mono-cortical titanium screws. Receives: Procedure: spontaneous bone regeneration |
| guided bone regeneration | Experimental | cyst enucleation will be followed by filling the intra-bony defect with Deproteinized Bovine Bone.
-Titanium mesh will cover the bone window completely and will be fixed to the bone using mono-cortical titanium screws. Receives: Procedure: guided bone regeneration |
What is being measured
The primary outcome is the main question the study is designed to answer.
The amount of change in the Bone density
Measuring the amount of change in the bone density using cone beam computed tomography in hounsfield unit
Measured: 6 months postoperatively
Secondary outcomes (1)
Percentage of bone area
Measuring the percentage of bone area using Histomorphometric analysis of decalcified bone sections with hematoxylin and eosin(H\&E) stain using image analyzer computer system.
Measured: 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start30 Dec 2024
- Primary completion30 Dec 2025
- Study completion1 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maxillary CystStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Mohamed Abdelzaher, Cairo University
- Investigators
- Mohamed A Abdelrasoul, PhD, Study director, faculty of oral and dental medicine, Cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06749158
- Sponsor's protocol ID
- CEBO-CU.2024
- Status last verified
- Mar 2026
- First submitted
- 19 Dec 2024
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiographic and Histological Assessment of Guided Bone Regeneration Using Deproteinized Bovine Bone Compared to Spontaneous Bone Regeneration of Maxillary Defects , Resulted From Enucleation of Intra-bony Cystic Lesions : Randomized Control Clinical Trial
- ClinicalTrials.gov ID
- NCT06749158
- Acronym / sponsor ID
- CEBO-CU.2024
- Conditions
- Maxillary Cyst
- Keywords
- Guided bone regeneration, Spontaneous bone regeneration, cyst enucleation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Dec 2024 (actual)
- Primary completion
- 30 Dec 2025 (actual)
- Study completion
- 1 Feb 2026 (actual)
- First posted
- 27 Dec 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.
Two groups of patients with maxillary defects resulted from enucleation of intra-bony cystic lesions the 1st group will be subjected to guided bone regeneration while the second group will be subjected to spontaneous bone regeneration.
Detailed description
- Two groups of patients with maxillary cystic lesions indicated for enucleation. One will be subjected to guided bone regeneration while the other will be subjected to spontaneous bone regeneration.
- General pre-operative procedures:
- All patients will undergo appropriate preparation involving periodontal therapy , proper oral hygiene measures in addition to endodontic treatment for the non-vital teeth related to the lesion. intraoperative procedure: (both groups)
- Scrubbing and draping of the patient will be carried out in a standard fashion using betadine surgical scrub.
- Local anesthesia will be administered (Articaine hydrochloride 4% with Epinephrine 1:100,000) injectable solution.
- Flap design: a sulcular incision will be done , extending two teeth beyond the area of interest followed by two oblique incisions on either side of the flap. A full thickness mucoperiosteal flap will be raised to expose the area occupied by the lesion.
- After flap reflection, the exposed bone related to the lesion will need to be removed to provide adequate accessibility before enucleation of the lesion.
- The specimens will be fixed in 10% formalin for pathological examination.
Intra-operative procedures - continued in first Group (GBR group) The intra-bony defect will be filled with Deproteinized Bovine Bone. In Both groups: Titanium mesh will be tailored with 3mm overlap at the edges to cover the bone window completely and fixed to the bone using mono-cortical titanium screws.
This is followed by Primary closure using 4-0 vicryl sutures that will be removed 10 days postoperatively.
Postoperative medications:
For both groups, postoperative antibiotic course of amoxicillin+ clavulanic acid 1 g tab (Augmentin) will be prescribed for one week and isobutylphenylpropionic acid 600 mg tab (Brufen) twice daily for one week. One shot of dexamethasone 8 mg vial will be administered intramuscularly immediately after the surgery together with ketorolac tromethamine 30 mg .
Postoperative care and instructions:
- Cold compresses will be applied for 10 minutes every 30 minutes for the first 24 hours postoperatively replaced by warm fomentation with the same rate for the next two days.
- Patients will be advised to maintain good oral hygiene and oral hygiene rinses using 2% chlorohexidine gluconate mouth rinse for a week starting from the second postoperative day (three times daily)
- Soft diet is recommended for the first 48 hours.
- The patients will be recalled after two days, after one week, at the end of the first month and then at three and six months to monitor the soft tissue healing where the sutures were removed after 10 days , then at the sixth months to evaluate the bony healing.
Radiographic assessment will be achieved by CBCT scan preoperatively, immediately postoperative ,and 6 months postoperatively to evaluate the change in the bone density . A total of three scans will be taken for each patient.
In the second group, the amount and percentage of bone gain will be measured based on the CBCT scans .
in the 6 months after the surgery ,titanium mesh and the screws will be removed and core biopsy will be taken for histological assessment.
dental implant/s will be placed in cases indicated for implantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| spontaneous bone regeneration | Active comparator | Procedure: spontaneous bone regenerationafter cyst enucleation, the intra-bony defect will be covered by Titanium mesh that is fixed by mono-cortical titanium screws. |
| guided bone regeneration | Experimental | Procedure: guided bone regenerationcyst enucleation will be followed by filling the intra-bony defect with Deproteinized Bovine Bone. -Titanium mesh will cover the bone window completely and will be fixed to the bone using mono-cortical titanium screws. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Presence of a well-defined pathological cystic lesion involving the maxilla, confirmed clinically and radiographically that require surgical enucleation resulting in an intra-bony defect.
- Mesiodistal dimension of the defect ranging from 1 cm to 4.0 cm.
- Patients aged 20 to 50 years, of either sex.
- Patients medically fit for surgical intervention under local or general anesthesia (ASA I or II)
- Absence of systemic conditions affecting bone healing (e.g., uncontrolled diabetes, osteoporosis)
Key exclusion criteria (7 listed)
- Pregnant or lactating women.
- Radiographically, Presence of multi-locular or aggressive lesions suggestive of odontogenic tumors (e.g., ameloblastoma)
- Patients with compromised immune status (e.g., HIV, long-term corticosteroid therapy)
- History of allergic reaction to any of the surgical materials used (e.g., titanium, bovine bone graft).
- Patients participating in another clinical trial or receiving investigational therapy during the study period.
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 |
|---|---|---|
| spontaneous bone regenerationstage 1 surgery: 1. after administration of Local anesthesia (Articaine hydrochloride 4% with Epinephrine 1:100,000 injectable solution), sulcular incision will be done , extending two teeth beyond the area of interest followed by two oblique incisions on either side of the flap 2. after flap elevation, enucleation of the cystic lesion and extraction of the non-restorable teeth related to the lesion will be done. 3. titanium mesh will be tailored with 3 mm overlap at the edges to cover the bone window completely and fixed to the bone using mono-cortical titanium screws. This will be followed by: Primary closure using 4-0 vicryl sutures that will be removed 10 days postoperatively. stage 2 surgery(after 6 months): 1. titanium mesh and screws will be removed. 2. core biopsy will be obtained for histological assessment 3. dental implant/s placement for cases indicated for implantation. | Procedure or surgery | spontaneous bone regeneration |
| guided bone regenerationstage 1 surgery after cyst enucleation and extraction of the non-restorable teeth related to the lesion, The intra-bony defect will be filled with Deproteinized Bovine Bone. -Titanium mesh will be tailored with 3mm overlap at the edges to cover the bone window completely and fixed to the bone using mono-cortical titanium screws. This will be followed by Primary closure using 4-0 vicryl sutures that will be removed 10 days postoperatively. stage 2 surgery(6 months later) : 1. titanium mesh will be removed. 2. core biopsy will be obtained for histological assessment. 3. dental implant/s placement for cases indicated for implantation. | Procedure or surgery | guided bone regeneration |
Primary outcome
The amount of change in the Bone density
Time frame: 6 months postoperatively
Measuring the amount of change in the bone density using cone beam computed tomography in hounsfield unit
1 secondary outcome
Percentage of bone area
Time frame: 6 months postoperatively
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 27 Mar 2026.
- Radiographic bone volume alteration after jaw cyst enucleation with or without simultaneous bone grafts: A prospective randomized studyLink provided by the sponsor.
- Review Int J Oral Sci . 2020 Dec 30;12(1):37. doi: 10.1038/s41368-020-00107-z. Titanium mesh for bone augmentation in oral implantology: current application and progressLink provided by the sponsor.
- Jaw cysts - filling or no filling after enucleation? A reviewLink provided by the sponsor.
- Bone Grafts and Substitutes in Dentistry: A Review of Current Trends and DevelopmentsLink provided by the sponsor.
- Barrier Membranes for Guided Bone Regeneration (GBR): A Focus on Recent Advances in Collagen MembranesLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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 A Abdelrasoul, PhD study director
faculty of oral and dental medicine, Cairo 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 spontaneous bone regeneration and guided bone regeneration in people with Maxillary Cyst, 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 7 inclusion and 7 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 27 Mar 2026. 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?
The amount of change in the Bone density (time frame: 6 months postoperatively). 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 27 Mar 2026.