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

NCT06749158 | Completed DMC

• 1 other identifier: CEBO-CU.2024
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Maxillary Cyst

Keywords

Guided bone regeneration; Spontaneous bone regeneration; cyst enucleation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Percentage of bone area

  6 months postoperatively

Other Outcomes (2)

• Percentage of mature bone

  6 months postoperatively

• amount and percentage of bone gain

  6 months

Study Arms (2)

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.

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.

Procedure: guided bone regeneration

Interventions

spontaneous bone regeneration PROCEDURE

stage 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.

spontaneous bone regeneration

guided bone regeneration PROCEDURE

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) : 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.

guided bone regeneration

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

faculty of oral and dental medicine, Cairo university

Cairo, Giza Governorate, 12613, Egypt

Location

Related 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 Officials

• Mohamed A Abdelrasoul, PhD

  faculty of oral and dental medicine, Cairo university

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: This trial is considered a randomized single blind clinical trial due to the following: * The participants will be blinded to the technique that will be used during the surgical procedure. * The operator will not be blinded for both techniques during the surgical procedure as the two techniques are different. * The outcome assessor cannot be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: December 19, 2024
• First Posted: December 27, 2024
• Study Start: December 30, 2024
• Primary Completion: December 30, 2025
• Study Completion: February 1, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)