Radiographic and Histological Assessment of GBR Using DBB Compared to Spontaneous Bone Regeneration of Maxillary Defects , Resulted From Enucleation of Intra-bony Cystic Lesions

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.

Study Overview

• Status: Completed
• Conditions: Maxillary Cyst
• Intervention / Treatment: Procedure: spontaneous bone regeneration; Procedure: guided 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 Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Giza Governorate
    • Cairo, Giza Governorate, Egypt, 12613
      • faculty of oral and dental medicine, Cairo university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 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.
2. Mesiodistal dimension of the defect ranging from 1 cm to 4.0 cm.
3. Patients aged 20 to 50 years, of either sex.
4. Patients medically fit for surgical intervention under local or general anesthesia (ASA I or II)
5. Absence of systemic conditions affecting bone healing (e.g., uncontrolled diabetes, osteoporosis)
6. Patients willing to participate in the study and able to provide informed written consent.
7. Availability of adequate postoperative follow-up (minimum of 6 months).

Exclusion Criteria:

1. Pregnant or lactating women.
2. Radiographically, Presence of multi-locular or aggressive lesions suggestive of odontogenic tumors (e.g., ameloblastoma)
3. Patients with compromised immune status (e.g., HIV, long-term corticosteroid therapy)
4. History of allergic reaction to any of the surgical materials used (e.g., titanium, bovine bone graft).
5. Patients participating in another clinical trial or receiving investigational therapy during the study period.
6. Presence of acute infection at the surgical site.
7. cysts with a known high recurrence rate such as Odontogenic keratocysts (OKC).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: spontaneous bone regeneration; after cyst enucleation, the intra-bony defect will be covered by Titanium mesh that is fixed by mono-cortical titanium screws.	Procedure: spontaneous bone regeneration; 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.
Experimental: guided bone regeneration; 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.	Procedure: guided bone regeneration; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 months postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months postoperatively

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of mature bone	Measuring the percentage of mature bone using Histomorphometric analysis of decalcified bone sections with Masson's trichrome stain using image analyzer computer system.	6 months postoperatively
amount and percentage of bone gain	Measuring the amount of bone gain using cone beam computed tomography in millimeters and the percentage in % (in the second group)	6 months

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: Mohamed A Abdelrasoul, PhD, faculty of oral and dental medicine, Cairo university

Publications and helpful links

Helpful Links

• Radiographic bone volume alteration after jaw cyst enucleation with or without simultaneous bone grafts: A prospective randomized study
• 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 progress
• Jaw cysts - filling or no filling after enucleation? A review
• Bone Grafts and Substitutes in Dentistry: A Review of Current Trends and Developments
• Barrier Membranes for Guided Bone Regeneration (GBR): A Focus on Recent Advances in Collagen Membranes

Study record dates

Study Major Dates

• Study Start (Actual): December 30, 2024
• Primary Completion (Actual): December 30, 2025
• Study Completion (Actual): February 1, 2026

Study Registration Dates

• First Submitted: December 19, 2024
• First Submitted That Met QC Criteria: December 23, 2024
• First Posted (Actual): December 27, 2024

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 23, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Guided bone regeneration; cyst enucleation; Spontaneous bone regeneration
• Other Study ID Numbers: CEBO-CU.2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No