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

Primary Purpose

Jaw Cysts

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Collagen sponge
GBR
CS/GBR
Sponsored by
The Dental Hospital of Zhejiang University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Jaw Cysts

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • jaw bone cyst with the maximum diameter from 1.5cm to 4.0cm;
  • focal teeth were preserved with root canal treatment;
  • no previous surgical treatment of the cyst site;
  • no evidence of acute inflammation;
  • in good physical status and oral health;
  • regular attendance at control visits.

Exclusion Criteria:

  • pregnancy or lactation;
  • aggregate systemic pathologies such as diabetes, thyroid disorders, bone metabolism diseases, among others;
  • patients taking calcium, bisphosphonates, glucocorticoids, or other drugs that can interfere with bone metabolism;
  • patients with uncontrolled periodontal conditions, endodontic conditions and other oral disorders;
  • heavy smoke (10 cigarettes/day or more).

Sites / Locations

  • Stomatology Hospital, Zhejiang University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

Experimental

Experimental

Arm Label

Control group

Collagen sponge group

GBR group

CS/GBR group

Arm Description

Patients in control group will be treated by cyst enucleation.

Cystic lesions in collagen sponge group will be filled by collagen sponge.

Cystic lesions in GBR group will be filled by deproteinized bovine substitute (DBBM, Bio-Oss®, granulometry 0.25-1 mm; Geistlich Pharma AG) and covered by absorbable collagen membrane (Bio-Gide®, Geistlich Pharma AG).

Cystic lesions in GBR group will be filled by collagen sponge and deproteinized bovine substitute (DBBM, Bio-Oss®, granulometry 0.25-1 mm; Geistlich Pharma AG) and covered by absorbable collagen membrane (Bio-Gide®, Geistlich Pharma AG).

Outcomes

Primary Outcome Measures

Shrinkage rate of residual bone cavity
(pre-operative cyst volume - 3 / 6 months post-operative defect volume) / pre-operative cyst volume × 100%.
Shrinkage rate of residual bone cavity
(pre-operative cyst volume - 3 / 6 months post-operative defect volume) / pre-operative cyst volume × 100%.

Secondary Outcome Measures

Bone density
HU value of newly-formed bone
Bone density
HU value of newly-formed bone

Full Information

First Posted
June 21, 2022
Last Updated
July 26, 2022
Sponsor
The Dental Hospital of Zhejiang University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT05478421
Brief Title
Radiographic Bone Volume Alteration After Jaw Cyst Enucleation With Different Bone Grafts
Official Title
Https://Www.Zjuss.cn
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
January 30, 2024 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Dental Hospital of Zhejiang University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Jaw Cysts

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
Patients in control group will be treated by cyst enucleation.
Arm Title
Collagen sponge group
Arm Type
Experimental
Arm Description
Cystic lesions in collagen sponge group will be filled by collagen sponge.
Arm Title
GBR group
Arm Type
Experimental
Arm Description
Cystic lesions in GBR group will be filled by deproteinized bovine substitute (DBBM, Bio-Oss®, granulometry 0.25-1 mm; Geistlich Pharma AG) and covered by absorbable collagen membrane (Bio-Gide®, Geistlich Pharma AG).
Arm Title
CS/GBR group
Arm Type
Experimental
Arm Description
Cystic lesions in GBR group will be filled by collagen sponge and deproteinized bovine substitute (DBBM, Bio-Oss®, granulometry 0.25-1 mm; Geistlich Pharma AG) and covered by absorbable collagen membrane (Bio-Gide®, Geistlich Pharma AG).
Intervention Type
Procedure
Intervention Name(s)
Collagen sponge
Intervention Description
The bone cavity will be filled with collagen sponge.
Intervention Type
Procedure
Intervention Name(s)
GBR
Intervention Description
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) .
Intervention Type
Procedure
Intervention Name(s)
CS/GBR
Intervention Description
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) .
Primary Outcome Measure Information:
Title
Shrinkage rate of residual bone cavity
Description
(pre-operative cyst volume - 3 / 6 months post-operative defect volume) / pre-operative cyst volume × 100%.
Time Frame
3 months
Title
Shrinkage rate of residual bone cavity
Description
(pre-operative cyst volume - 3 / 6 months post-operative defect volume) / pre-operative cyst volume × 100%.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Bone density
Description
HU value of newly-formed bone
Time Frame
3 months
Title
Bone density
Description
HU value of newly-formed bone
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: jaw bone cyst with the maximum diameter from 1.5cm to 4.0cm; focal teeth were preserved with root canal treatment; no previous surgical treatment of the cyst site; no evidence of acute inflammation; in good physical status and oral health; regular attendance at control visits. Exclusion Criteria: pregnancy or lactation; aggregate systemic pathologies such as diabetes, thyroid disorders, bone metabolism diseases, among others; patients taking calcium, bisphosphonates, glucocorticoids, or other drugs that can interfere with bone metabolism; patients with uncontrolled periodontal conditions, endodontic conditions and other oral disorders; heavy smoke (10 cigarettes/day or more).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jue Shi, Doctor
Email
dentistsj@zju.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Yu Liu, Doctor
Phone
+86 18758286734
Email
7514061@zju.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jue Shi, Doctor
Organizational Affiliation
Zhejiang University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stomatology Hospital, Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jue Shi, Doctor
Phone
+86 13757171359
Email
dentistsj@zju.edu.cn

12. IPD Sharing Statement

Citations:
PubMed Identifier
34749963
Citation
Berretta LM, Melo G, Mello FW, Lizio G, Rivero ERC. Effectiveness of marsupialisation and decompression on the reduction of cystic jaw lesions: a systematic review. Br J Oral Maxillofac Surg. 2021 Dec;59(10):E17-E42. doi: 10.1016/j.bjoms.2021.03.004. Epub 2021 Mar 23.
Results Reference
background
PubMed Identifier
29396318
Citation
Buchbender M, Neukam FW, Lutz R, Schmitt CM. Treatment of enucleated odontogenic jaw cysts: a systematic review. Oral Surg Oral Med Oral Pathol Oral Radiol. 2018 May;125(5):399-406. doi: 10.1016/j.oooo.2017.12.010. Epub 2017 Dec 29.
Results Reference
background
PubMed Identifier
10981973
Citation
Chiapasco M, Rossi A, Motta JJ, Crescentini M. Spontaneous bone regeneration after enucleation of large mandibular cysts: a radiographic computed analysis of 27 consecutive cases. J Oral Maxillofac Surg. 2000 Sep;58(9):942-8; discussion 949. doi: 10.1053/joms.2000.8732.
Results Reference
background
PubMed Identifier
26501020
Citation
Chacko R, Kumar S, Paul A, Arvind. Spontaneous Bone Regeneration After Enucleation of Large Jaw Cysts: A Digital Radiographic Analysis of 44 Consecutive Cases. J Clin Diagn Res. 2015 Sep;9(9):ZC84-9. doi: 10.7860/JCDR/2015/13394.6524. Epub 2015 Sep 1.
Results Reference
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Radiographic Bone Volume Alteration After Jaw Cyst Enucleation With Different Bone Grafts

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