Jaw CystsNCT06567535
Treatment of Mandibular Bone Cyst by Navigation and Endoscopy
A study testing Navigation and endoscopy in people with Jaw Cysts, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial summary
In this study, with the assistance of endoscopic technology and intraoperative navigation technology, the removal and curettage of large odontogenic jaw cyst occurred in the mandible were performed to reduce the rate of postoperative nerve injury. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Jaw Cysts
- What is being tested?
- Navigation and endoscopy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteChina
- Study dates
- 20 Aug 2024to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- They are between 18 and 75 years old
- Imaging and puncture pathology showed odontogenic cystic lesion of the mandible
- Cystic lesions greater than or equal to 2cm in diameter and spread to the inferior alveolar nerve
- New or recurrent cyst lesions, or odontogenic cystic lesions that are still greater than or equal to 2cm after other treatment such as fenestration and affecting the lower alveolar nerve
- No serious systemic disease, tolerant of general anesthesia
- Patients undergoing surgical treatment for mandibular bone cysts under general anesthesia
Show all 9Show fewer
- There was no inferior alveolar nerve injury before operation
- Have not participated in other clinical trials within 30 days
- Patients who volunteer to participate in the program and sign informed consent
Who cannot join
- The patient has severe systemic disease or pregnancy, and is judged to be unable to tolerate the course of this clinical study and cannot tolerate general anesthesia after evaluation by the research team and multidisciplinary consultation
- Inability to complete the entire clinical research process due to personal, social, and economic reasons
- Patients with psychiatric disorders or inability to perceive and communicate normally, such as schizophrenia, claustrophobia, etc., are unable to complete the examination and cooperate in the entire clinical research process
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
WangYan
Guangzhou, Guangdong, 510000
Yan Wang, 13825119105 ext. 86, wangy573@mail.sysu.edu.cn
YILIN HE, 13680281880 ext. 86, 839506041@qq.com
About this study
Official title: A Single-arm, Single-center Clinical Study of Endoscopic Combined With Intraoperative Navigation-assisted Treatment of Giant Mandibular Cysts
In this study, with the assistance of endoscopic technology and intraoperative navigation technology, the removal and curettage of large odontogenic jaw cyst occurred in the mandible were performed to reduce the rate of postoperative nerve injury. In this study, the investigators compared the efficacy of traditional extraction and curettage with endoscopic navigation assistance in the treatment of giant mandibular bone cysts. In this study, the rate of inferior alveolar nerve injury 1 month after surgery was taken as the main outcome index, and the recurrence rate 1 year after surgery was taken as the secondary outcome index, to explore whether endoscopic combined with intraoperative navigation-assisted treatment of giant mandibular bone cyst could achieve lower postoperative nerve injury rate and postoperative recurrence rate.
Read the detailed description
This study hypothesized that endoscopy combined with intraoperative navigation-assisted treatment of giant mandibular bone cysts was more effective than the traditional surgical method of removal and curettage. In this study, a prospective, single-arm, Phase II clinical study was used to design the protocol, and the estimated rate of postoperative nerve injury was reduced by about 12% from 32% to 20% compared with traditional surgery. This study started from the recruitment of subjects, oral panoramic film, maxillofacial CT and other imaging examinations were performed to confirm the diagnosis. After preliminary screening according to the inclusion and exclusion criteria, patients were enrolled after signing the informed consent letter. Endoscopic and navigational techniques were used for surgical treatment. This study referred to the prospective study of Abdullah Hanfesh et al. to evaluate the function of the inferior alveolar nerve: the bilateral mandibular and lower lip were divided into four areas: area A, area B, area C, and area D. The four areas will be lightly touched, acupuncture, cold and hot stimulation, and two-point discrimination detection four times respectively, and the detection situation of each area will be recorded. Inferior alveolar nerve function was detected before and 1 month after surgery. Light touch detection 4 points, acupuncture detection 1 point, hot and cold stimulation 1 point, two-point discrimination detection 5 points showed no nerve damage. Any other score for any of the above is considered to be nerve damage. The main study measure: postoperative nerve injury rate was calculated until the last subject was followed up. The main efficacy index of this study was the postoperative nerve injury rate of endoscopic combined with intraoperative navigation-assisted treatment of giant mandibular bone cysts. The hypothesis of this study is that the postoperative nerve injury rate of endoscopy combined with intraoperative navigation-assisted treatment of giant mandibular cyst is lower than that of traditional excision and curettage. Study parameters were set as follows: α=0.025 (unilateral) and Power=80%. According to the results of previous studies or pre-tests, the postoperative nerve injury rate of the endoscopic navigation group was reduced by about 20% to 12%. 109 cases were calculated using PASS 15.0 software, and 122 subjects were included considering the 10% shedding rate.
- Conditions
- Jaw Cysts
- Being tested
- Navigation and endoscopy
- Medical subject headings
- Jaw Cysts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Navigation and endoscopyProcedure or surgery
The model was reconstructed using patient CT data, and intraoperative surgery was performed using endoscopy and navigation.
| Study group | Role | What they receive |
|---|---|---|
| Navigation and endoscopy Group | Experimental | Preoperative copies of the patient's maxillofacial imaging data were digitally designed, professional software was used to segment cystic lesions and segment the inferior alveolar nerve together, and then the data was imported into the navigation system. The surgeon placed a mandibular reference frame in the anterior mandibular region, and used the navigation probe to accurately locate the difficult areas such as the anterior part of the capsule cavity, the apical part of the tooth root and the ascending branch of the mandible under the guidance of navigation. After accurate positioning was obtained, the navigation adapter was loaded onto the endoscope to locate the lesions in all directions and the inferior alveolar nerve under visual conditions, and further precisely curettage the lesions in the cystic cavity with the assistance of the adapter. Receives: Procedure: Navigation and endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of inferior alveolar nerve injury at one month postoperatively
Rate of inferior alveolar nerve injury at one month postoperatively
Measured: one month
Secondary outcomes (1)
Recurrence rate one year after surgery
Recurrence rate one year after surgery
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2024
- Study start20 Aug 2024 (estimated)
- Primary completion10 Nov 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Jaw CystsStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 122 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yan Wang, Principal investigator, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06567535
- Sponsor's protocol ID
- SYSKY-2024-261-03
- Status last verified
- Aug 2024
- First submitted
- 11 Jul 2024
- Last updated
- 22 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rajendra Santosh AB. Odontogenic Cysts. Dent Clin North Am. 2020 Jan;64(1):105-119. doi: 10.1016/j.cden.2019.08.002. Epub 2019 Oct 18.
PubMed 31735221Manor E, Kachko L, Puterman MB, Szabo G, Bodner L. Cystic lesions of the jaws - a clinicopathological study of 322 cases and review of the literature. Int J Med Sci. 2012;9(1):20-6. doi: 10.7150/ijms.9.20. Epub 2011 Nov 9.
PubMed 22211085Anavi Y, Gal G, Miron H, Calderon S, Allon DM. Decompression of odontogenic cystic lesions: clinical long-term study of 73 cases. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2011 Aug;112(2):164-9. doi: 10.1016/j.tripleo.2010.09.069. Epub 2010 Dec 30.
PubMed 21194990Marin S, Kirnbauer B, Rugani P, Mellacher A, Payer M, Jakse N. The effectiveness of decompression as initial treatment for jaw cysts: A 10-year retrospective study. Med Oral Patol Oral Cir Bucal. 2019 Jan 1;24(1):e47-e52. doi: 10.4317/medoral.22526.
PubMed 30573706Wang Y, Chang S, Lin Z, Chen R, Huang Z. Endoscopic-assisted enucleation of large mandibular odontogenic cysts. Oral Surg Oral Med Oral Pathol Oral Radiol. 2020 Feb;129(2):115-119. doi: 10.1016/j.oooo.2019.05.012. Epub 2019 Jun 6.
PubMed 31786170Tamiolakis P, Thermos G, Tosios KI, Sklavounou-Andrikopoulou A. Demographic and Clinical Characteristics of 5294 Jaw Cysts: A Retrospective Study of 38 Years. Head Neck Pathol. 2019 Dec;13(4):587-596. doi: 10.1007/s12105-019-01011-7. Epub 2019 Feb 13.
PubMed 30758760Wakolbinger R, Beck-Mannagetta J. Long-term results after treatment of extensive odontogenic cysts of the jaws: a review. Clin Oral Investig. 2016 Jan;20(1):15-22. doi: 10.1007/s00784-015-1552-y. Epub 2015 Aug 8.
PubMed 26250795Gao Z, Ni QW, Gao W, Liu YP, Zhang Q. Application of endoscopy to treat mandibular keratocystic odontogenic tumors. Braz J Med Biol Res. 2017 Jul 10;50(8):e6209. doi: 10.1590/1414-431X20176209.
PubMed 28700034Sembronio S, Albiero AM, Zerman N, Costa F, Politi M. Endoscopically assisted enucleation and curettage of large mandibular odontogenic keratocyst. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2009 Feb;107(2):193-6. doi: 10.1016/j.tripleo.2008.07.020. Epub 2008 Sep 17.
PubMed 18801672Huang Z, Huang Z, Zhang D, Hu H, Liang Q, Chen W. Endoscopically-assisted operations in the treatment of odontogenic peripheral osteomyelitis of the posterior mandible. Br J Oral Maxillofac Surg. 2016 Jun;54(5):542-6. doi: 10.1016/j.bjoms.2016.02.023. Epub 2016 Mar 26.
PubMed 27025231Azarmehr I, Stokbro K, Bell RB, Thygesen T. Surgical Navigation: A Systematic Review of Indications, Treatments, and Outcomes in Oral and Maxillofacial Surgery. J Oral Maxillofac Surg. 2017 Sep;75(9):1987-2005. doi: 10.1016/j.joms.2017.01.004. Epub 2017 Jan 18.
PubMed 28193444Sukegawa S, Kanno T, Furuki Y. Application of computer-assisted navigation systems in oral and maxillofacial surgery. Jpn Dent Sci Rev. 2018 Aug;54(3):139-149. doi: 10.1016/j.jdsr.2018.03.005. Epub 2018 May 7.
PubMed 30128061de Geer AF, Brouwer de Koning SG, van Alphen MJA, van der Mierden S, Zuur CL, van Leeuwen FWB, Loeve AJ, van Veen RLP, Karakullukcu MB. Registration methods for surgical navigation of the mandible: a systematic review. Int J Oral Maxillofac Surg. 2022 Oct;51(10):1318-1329. doi: 10.1016/j.ijom.2022.01.017. Epub 2022 Feb 11.
PubMed 35165005Sozzi D, Filippi A, Canzi G, De Ponti E, Bozzetti A, Novelli G. Surgical Navigation in Mandibular Reconstruction: Accuracy Evaluation of an Innovative Protocol. J Clin Med. 2022 Apr 6;11(7):2060. doi: 10.3390/jcm11072060.
PubMed 35407667Hanfesh A, Salma RG, Al Mutairi K, AlShiha SK, Al Otaibi S. The neurosensory deficit of inferior alveolar nerve following bilateral sagittal split osteotomy: a prospective study. Oral Maxillofac Surg. 2022 Sep;26(3):401-415. doi: 10.1007/s10006-021-01005-2. Epub 2021 Sep 12.
PubMed 34510239
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Single-center Clinical Study of Endoscopic Combined With Intraoperative Navigation-assisted Treatment of Giant Mandibular Cysts
- ClinicalTrials.gov ID
- NCT06567535
- Acronym / sponsor ID
- SYSKY-2024-261-03
- Conditions
- Jaw Cysts
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 20 Aug 2024 (estimated)
- Primary completion
- 10 Nov 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 22 Aug 2024 (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.
In this study, with the assistance of endoscopic technology and intraoperative navigation technology, the removal and curettage of large odontogenic jaw cyst occurred in the mandible were performed to reduce the rate of postoperative nerve injury. In this study, the investigators compared the efficacy of traditional extraction and curettage with endoscopic navigation assistance in the treatment of giant mandibular bone cysts. In this study, the rate of inferior alveolar nerve injury 1 month after surgery was taken as the main outcome index, and the recurrence rate 1 year after surgery was taken as the secondary outcome index, to explore whether endoscopic combined with intraoperative navigation-assisted treatment of giant mandibular bone cyst could achieve lower postoperative nerve injury rate and postoperative recurrence rate.
Detailed description
This study hypothesized that endoscopy combined with intraoperative navigation-assisted treatment of giant mandibular bone cysts was more effective than the traditional surgical method of removal and curettage. In this study, a prospective, single-arm, Phase II clinical study was used to design the protocol, and the estimated rate of postoperative nerve injury was reduced by about 12% from 32% to 20% compared with traditional surgery. This study started from the recruitment of subjects, oral panoramic film, maxillofacial CT and other imaging examinations were performed to confirm the diagnosis. After preliminary screening according to the inclusion and exclusion criteria, patients were enrolled after signing the informed consent letter. Endoscopic and navigational techniques were used for surgical treatment. This study referred to the prospective study of Abdullah Hanfesh et al. to evaluate the function of the inferior alveolar nerve: the bilateral mandibular and lower lip were divided into four areas: area A, area B, area C, and area D. The four areas will be lightly touched, acupuncture, cold and hot stimulation, and two-point discrimination detection four times respectively, and the detection situation of each area will be recorded. Inferior alveolar nerve function was detected before and 1 month after surgery. Light touch detection 4 points, acupuncture detection 1 point, hot and cold stimulation 1 point, two-point discrimination detection 5 points showed no nerve damage. Any other score for any of the above is considered to be nerve damage. The main study measure: postoperative nerve injury rate was calculated until the last subject was followed up. The main efficacy index of this study was the postoperative nerve injury rate of endoscopic combined with intraoperative navigation-assisted treatment of giant mandibular bone cysts. The hypothesis of this study is that the postoperative nerve injury rate of endoscopy combined with intraoperative navigation-assisted treatment of giant mandibular cyst is lower than that of traditional excision and curettage. Study parameters were set as follows: α=0.025 (unilateral) and Power=80%. According to the results of previous studies or pre-tests, the postoperative nerve injury rate of the endoscopic navigation group was reduced by about 20% to 12%. 109 cases were calculated using PASS 15.0 software, and 122 subjects were included considering the 10% shedding rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Navigation and endoscopy Group | Experimental | Procedure: Navigation and endoscopyPreoperative copies of the patient's maxillofacial imaging data were digitally designed, professional software was used to segment cystic lesions and segment the inferior alveolar nerve together, and then the data was imported into the navigation system. The surgeon placed a mandibular reference frame in the anterior mandibular region, and used the navigation probe to accurately locate the difficult areas such as the anterior part of the capsule cavity, the apical part of the tooth root and the ascending branch of the mandible under the guidance of navigation. After accurate positioning was obtained, the navigation adapter was loaded onto the endoscope to locate the lesions in all directions and the inferior alveolar nerve under visual conditions, and further precisely curettage the lesions in the cystic cavity with the assistance of the adapter. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- They are between 18 and 75 years old
- Imaging and puncture pathology showed odontogenic cystic lesion of the mandible
- Cystic lesions greater than or equal to 2cm in diameter and spread to the inferior alveolar nerve
- New or recurrent cyst lesions, or odontogenic cystic lesions that are still greater than or equal to 2cm after other treatment such as fenestration and affecting the lower alveolar nerve
- No serious systemic disease, tolerant of general anesthesia
Key exclusion criteria (3 listed)
- The patient has severe systemic disease or pregnancy, and is judged to be unable to tolerate the course of this clinical study and cannot tolerate general anesthesia after evaluation by the research team and multidisciplinary consultation
- Inability to complete the entire clinical research process due to personal, social, and economic reasons
- Patients with psychiatric disorders or inability to perceive and communicate normally, such as schizophrenia, claustrophobia, etc., are unable to complete the examination and cooperate in the entire clinical research process
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 |
|---|---|---|
| Navigation and endoscopyThe model was reconstructed using patient CT data, and intraoperative surgery was performed using endoscopy and navigation. | Procedure or surgery | Navigation and endoscopy Group |
Primary outcome
Rate of inferior alveolar nerve injury at one month postoperatively
Time frame: one month
Rate of inferior alveolar nerve injury at one month postoperatively
1 secondary outcome
Recurrence rate one year after surgery
Time frame: one year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2024.
- Results publication: PubMed 31735221Rajendra Santosh AB. Odontogenic Cysts. Dent Clin North Am. 2020 Jan;64(1):105-119. doi: 10.1016/j.cden.2019.08.002. Epub 2019 Oct 18.
- Results publication: PubMed 22211085Manor E, Kachko L, Puterman MB, Szabo G, Bodner L. Cystic lesions of the jaws - a clinicopathological study of 322 cases and review of the literature. Int J Med Sci. 2012;9(1):20-6. doi: 10.7150/ijms.9.20. Epub 2011 Nov 9.
- Results publication: PubMed 21194990Anavi Y, Gal G, Miron H, Calderon S, Allon DM. Decompression of odontogenic cystic lesions: clinical long-term study of 73 cases. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2011 Aug;112(2):164-9. doi: 10.1016/j.tripleo.2010.09.069. Epub 2010 Dec 30.
- Results publication: PubMed 30573706Marin S, Kirnbauer B, Rugani P, Mellacher A, Payer M, Jakse N. The effectiveness of decompression as initial treatment for jaw cysts: A 10-year retrospective study. Med Oral Patol Oral Cir Bucal. 2019 Jan 1;24(1):e47-e52. doi: 10.4317/medoral.22526.
- Results publication: PubMed 31786170Wang Y, Chang S, Lin Z, Chen R, Huang Z. Endoscopic-assisted enucleation of large mandibular odontogenic cysts. Oral Surg Oral Med Oral Pathol Oral Radiol. 2020 Feb;129(2):115-119. doi: 10.1016/j.oooo.2019.05.012. Epub 2019 Jun 6.
- Results publication: PubMed 30758760Tamiolakis P, Thermos G, Tosios KI, Sklavounou-Andrikopoulou A. Demographic and Clinical Characteristics of 5294 Jaw Cysts: A Retrospective Study of 38 Years. Head Neck Pathol. 2019 Dec;13(4):587-596. doi: 10.1007/s12105-019-01011-7. Epub 2019 Feb 13.
- Results publication: PubMed 26250795Wakolbinger R, Beck-Mannagetta J. Long-term results after treatment of extensive odontogenic cysts of the jaws: a review. Clin Oral Investig. 2016 Jan;20(1):15-22. doi: 10.1007/s00784-015-1552-y. Epub 2015 Aug 8.
- Results publication: PubMed 28700034Gao Z, Ni QW, Gao W, Liu YP, Zhang Q. Application of endoscopy to treat mandibular keratocystic odontogenic tumors. Braz J Med Biol Res. 2017 Jul 10;50(8):e6209. doi: 10.1590/1414-431X20176209.
- Results publication: PubMed 18801672Sembronio S, Albiero AM, Zerman N, Costa F, Politi M. Endoscopically assisted enucleation and curettage of large mandibular odontogenic keratocyst. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2009 Feb;107(2):193-6. doi: 10.1016/j.tripleo.2008.07.020. Epub 2008 Sep 17.
- Results publication: PubMed 27025231Huang Z, Huang Z, Zhang D, Hu H, Liang Q, Chen W. Endoscopically-assisted operations in the treatment of odontogenic peripheral osteomyelitis of the posterior mandible. Br J Oral Maxillofac Surg. 2016 Jun;54(5):542-6. doi: 10.1016/j.bjoms.2016.02.023. Epub 2016 Mar 26.
- Results publication: PubMed 28193444Azarmehr I, Stokbro K, Bell RB, Thygesen T. Surgical Navigation: A Systematic Review of Indications, Treatments, and Outcomes in Oral and Maxillofacial Surgery. J Oral Maxillofac Surg. 2017 Sep;75(9):1987-2005. doi: 10.1016/j.joms.2017.01.004. Epub 2017 Jan 18.
- Results publication: PubMed 30128061Sukegawa S, Kanno T, Furuki Y. Application of computer-assisted navigation systems in oral and maxillofacial surgery. Jpn Dent Sci Rev. 2018 Aug;54(3):139-149. doi: 10.1016/j.jdsr.2018.03.005. Epub 2018 May 7.
- Individual participant dataSharing planned: No
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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.
Yan Wang principal investigator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen 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 Navigation and endoscopy in people with Jaw Cysts, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University 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 9 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 22 Aug 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yan Wang (13825119105 ext. 86, wangy573@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of inferior alveolar nerve injury at one month postoperatively (time frame: one month). 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 NCT06567535, which also lists 15 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 22 Aug 2024.