Jaw CystsNCT05478421
Radiographic Bone Volume Alteration After Jaw Cyst Enucleation With Different Bone Grafts
A study testing Collagen sponge, GBR and CS/GBR in people with Jaw Cysts, run by The Dental Hospital of Zhejiang University School of Medicine at 1 site in China.
Trial 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% . Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Jaw Cysts
- What is being tested?
- Collagen sponge, GBR and CS/GBR
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2022to 30 Sep 2024
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Jue Shi, Doctor contact
China1 site, 1 recruiting
- Recruiting
Stomatology Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
Jue Shi, Doctor, +86 13757171359, dentistsj@zju.edu.cn
About this study
Official title: Https://Www.Zjuss.cn
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.
Read more
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
- Being tested
- Collagen sponge, GBR, CS/GBR
- Medical subject headings
- Jaw Cysts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collagen spongeProcedure or surgery
The bone cavity will be filled with collagen sponge.
GBRProcedure or surgery
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) .
CS/GBRProcedure or surgery
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) .
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Patients in control group will be treated by cyst enucleation. |
| Collagen sponge group | Experimental | Cystic lesions in collagen sponge group will be filled by collagen sponge. Receives: Procedure: Collagen sponge |
| GBR group | Experimental | 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). Receives: Procedure: GBR |
| CS/GBR group | Experimental | 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). Receives: Procedure: CS/GBR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shrinkage rate of residual bone cavity
(pre-operative cyst volume - 3 / 6 months post-operative defect volume) / pre-operative cyst volume × 100%.
Measured: 3 months
Shrinkage rate of residual bone cavity
(pre-operative cyst volume - 3 / 6 months post-operative defect volume) / pre-operative cyst volume × 100%.
Measured: 6 months
Secondary outcomes (2)
Bone density
HU value of newly-formed bone
Measured: 3 months
Bone density
HU value of newly-formed bone
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2022
- Study start1 Jun 2022
- Primary completion30 Jan 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Jaw CystsStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Dental Hospital of Zhejiang University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shi Jue, The Dental Hospital of Zhejiang University School of Medicine
- Investigators
- Jue Shi, Doctor, Principal investigator, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05478421
- Sponsor's protocol ID
- OMSJC
- Status last verified
- Jul 2022
- First submitted
- 21 Jun 2022
- Last updated
- 28 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34749963Buchbender 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.
PubMed 29396318Chiapasco 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.
PubMed 10981973Chacko 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.
PubMed 26501020
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Https://Www.Zjuss.cn
- ClinicalTrials.gov ID
- NCT05478421
- Acronym / sponsor ID
- OMSJC
- Conditions
- Jaw Cysts
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- The Dental Hospital of Zhejiang University School of MedicineUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 30 Jan 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 28 Jul 2022 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Patients in control group will be treated by cyst enucleation. |
| Collagen sponge group | Experimental | Procedure: Collagen spongeCystic lesions in collagen sponge group will be filled by collagen sponge. |
| GBR group | Experimental | Procedure: GBRCystic 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). |
| CS/GBR group | Experimental | Procedure: CS/GBRCystic 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). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (5 listed)
- 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).
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 |
|---|---|---|
| Collagen spongeThe bone cavity will be filled with collagen sponge. | Procedure or surgery | Collagen sponge group |
| GBRThe 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 or surgery | GBR group |
| CS/GBRThe 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) . | Procedure or surgery | CS/GBR group |
Primary outcome
Shrinkage rate of residual bone cavity
Time frame: 3 months
(pre-operative cyst volume - 3 / 6 months post-operative defect volume) / pre-operative cyst volume × 100%.
Shrinkage rate of residual bone cavity
Time frame: 6 months
(pre-operative cyst volume - 3 / 6 months post-operative defect volume) / pre-operative cyst volume × 100%.
2 secondary outcomes
Bone density
Time frame: 3 months
Bone density
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2022.
- Background: PubMed 34749963Berretta 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.
- Background: PubMed 29396318Buchbender 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.
- Background: PubMed 10981973Chiapasco 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.
- Background: PubMed 26501020Chacko 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.
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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.
Jue Shi, Doctor contact
Jue Shi, Doctor principal investigator
Zhejiang 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 Collagen sponge, GBR and CS/GBR in people with Jaw Cysts, run by The Dental Hospital of Zhejiang University School of Medicine at 1 site in China.
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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 28 Jul 2022. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jue Shi, Doctor (dentistsj@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shrinkage rate of residual bone cavity (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05478421, which also lists 4 linked publications.
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 28 Jul 2022.