Radiographic Bone Volume Alteration After Jaw Cyst Enucleation With Different Bone Grafts

NCT05478421 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2022-07-28

No results posted yet for this study

Summary

For decades, implantology has attracted extensive interest for restoration in patients with the defect of dentition. It has emerged as a very established prosthetic with a 5-year survival rate of 96% . However, defect of dentition resulted from jaw cyst remains an ongoing challenge for subsequent implantation treatment. Since it presents as a larger bone lesion than normal teeth extraction sockets and bone quality and quantity in teeth missing area can significantly impact dental implant failure rates .

Jaw cysts are one of the most common diseases occurring in the oral and maxillofacial area, and often cause destructive bone lesions followed by specific clinical features, such as located pain, swelling and loosen teeth. Over the years, enucleation of jaw bone cysts has been the standard method of management of jaw cysts because its conservational protocol to remove the lesion thoroughly and reserve important structures and functions. Unfortunately, management of the residual bony cavity remains as a huge dilemma whether to filing the defect with additional material. Clot formation in the first instance is the conventional option for residual cavity recovery. Iodoform sponges are traditionally used in cysts as stuffing material for inflammation preventative purpose, however, it cannot help with the following bone formation. Without any bone filling material, researches revealed that spontaneous bone healing index can be from 25.85% to 76% and from 43.46% to 81.03% after 6 and 12 months post-operative respectively. These ranged results indicated that spontaneous bone healing is not efficient enough especially for patients with the extraction of relevant teeth who may process a subsequent surgery for implantation. As an alternative to this, bone graft material in the surgery has gained increasing attention. Autogenous bone, artificial bone substitutes and mix of them are widely applied to achieve higher bone regeneration. Thereby an alternative surgical procedure should be considered for patients at risk of missing teeth because of jaw cysts. Whether bone graft material could make a remarkable improvement of bone regeneration after cyst enucleation and would this actually benefit the follow-up implantation? Answers are urged to be delivered.

Based on the published data, few studies have yielded in the bone healing comparison of spontaneous bone healing and xenograft in jaw cysts. Besides, with the development of medical radiograph, three-dimensional images have played a more important role in the clinic. Whereas, to our knowledge, most researches had adopted two-dimensional radiograph for measurement, such as panoramic radiographs rather than three dimensions.

Therefore, we conducted a prospective study to evaluate the shrinkage rate in cyst patients with different extra xenograft (Bio-Oss and collagen sponge). Cone beam computed tomography (CBCT) and three-dimensional model reconstruction were recommended for radiographic and digital analyzation. In summary, this study was aimed to evaluate bone volume augmentation after jaw cyst enucleation with different bone substitutes filling by CBCT and to analyze other influence factors for bone formation as well.

Conditions

  • Jaw Cysts

Interventions

PROCEDURE

Collagen sponge

The bone cavity will be filled with collagen sponge.

PROCEDURE

GBR

The bone cavity will be applied with guided bone regeneration with deproteinized bovine substitute (DBBM, Bio-Oss®, granulometry 0.25-1 mm; Geistlich Pharma AG) and absorbable collagen membrane (Bio-Gide®, Geistlich Pharma AG) .

PROCEDURE

CS/GBR

The bone cavity will be applied with guided bone regeneration with collagen sponge and deproteinized bovine substitute (DBBM, Bio-Oss®, granulometry 0.25-1 mm; Geistlich Pharma AG) and absorbable collagen membrane (Bio-Gide®, Geistlich Pharma AG) .

Sponsors & Collaborators

  • The Dental Hospital of Zhejiang University School of Medicine

    lead OTHER

Principal Investigators

  • Jue Shi, Doctor · Zhejiang University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-06-01
Primary Completion
2024-01-30
Completion
2024-09-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05478421 on ClinicalTrials.gov