Partially Edentulous MandibleNCT05983718
A Study of Surgical Guide Assisted Dental Implantation in Bangladesh
A study testing Surgical Guide and Guide-pin-assisted Freehand surgery in people with Partially Edentulous Mandible and Dental Implantation, run by Dhaka Dental College and Hospital at 1 site in Bangladesh.
Trial summary
This is a randomized controlled study that aims to compare the accuracy between full-guided with guide-pin-assisted free-hand dental implant surgeries. The basis of evaluation in each case is the comparison of the preoperative digital plan with the actual postoperative status. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Partially Edentulous Mandible, Dental Implantation
- What is being tested?
- Surgical Guide and Guide-pin-assisted Freehand surgery
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteBangladesh
- Study dates
- 23 Aug 2023to 31 Jul 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients of age between 18 to 75 and of any gender
- Patient fit for implantation (satisfactory soft and hard tissue conditions and occlusion)
- Partially edentulous patient
Who cannot join
- Patient with pregnancy
- Patient with uncontrolled diabetes mellitus.
- Patient who needed dentoalveolar or associated soft tissue reconstruction procedure
- Patient taking bisphosphonate or have any history of systemic or local bone disease
- Recent extracted sites
- Patients with a history of smoking, alcoholism
Show all 13Show fewer
- Patient with a history of head-neck radiation
- Patient with associated periapical pathology or history of parafunctional habit
- Patient needs bone grafting.
- Known HIV, Hepatitis B, or Hepatitis C infection.
- Limited mouth opening, which, in the examiner's opinion, would risk the success of the intervention
- Local infection
- Known allergy to any component of the implant or the implant guide
Trial locations and contacts
1 site in 1 country.
Bangladesh1 site, 1 recruiting
- Recruiting
Dhaka Dental College and Hospital
Dhaka, 1206
Dr. Md. Al-Amin Sarkar, +8801715748863, dr.sarkar.bds@gmail.com
Dr. Mst. Jannatul Ferdous, +88029038266, ddch@hospi.dghs.gov.bd
About this study
Official title: Comparison of Positional Accuracy in Dental Implant Placement Between Conventionally Used Guide Pin and 3D Printed Surgical Guide Developed From CBCT
This is a randomized controlled study that aims to compare the accuracy between full-guided with guide-pin-assisted free-hand dental implant surgeries. The basis of evaluation in each case is the comparison of the preoperative digital plan with the actual postoperative status.
Read the detailed description
Dental implant surgery is a treatment that replaces damaged or missing teeth with artificial teeth that are aesthetically and functionally similar to natural teeth. For a successful implant surgery, it is necessary to use digital planning software in conjunction with a cone-beam CT scan and a custom-made 3D-printed surgical guide. In developing countries like Bangladesh, surgical guide-assisted dental implant surgery is absent. Doctors attend implant surgeries relying on their visual assessment from x-ray images or CBCT data. They need to cut the outer soft tissue, expose the bone, and use a guide pin to confirm the direction and location. Then they perform implant surgery following the hole created by the guide pin, similar to free-hand surgery. But the overall procedure is still highly invasive and has low accuracy.
Free-hand implant surgeries are still in practice everywhere. The application of a guide pin has been observed in some places to enhance the situation. A guide pin helps an operator recognize the position and angle of an alveolar bone when forming an implantation hole in the alveolar bone to insert an implant into the alveolar bone. Doctors insert a guide pin to the implant site with minimal incision and then confirm the desired direction and location with a radiographic image. However, we need a proper clinical evaluation to compare fully-guided surgeries to guide-pin-assisted surgeries to understand the accuracy of both processes.
The accuracy of the pre-planned 3D-printed surgical guide is well established. Introducing dental software and guided surgery has already achieved higher acceptance in implant surgery. Several patients from several privileged parts of the world benefit from surgical guides. But the usual design convention includes intraoral scanner data with CBCT. However, intraoral scanners are still unavailable in many dental hospitals. The study is designed to address the precision of dental implant surgeries worldwide, especially where the intraoral scanner is not present. In our research, we will focus on partially edentulous patients. And our design procedure will not be dependent on intra-oral scanner data. As partially edentulous patients are higher in number and CBCT machines readily available in hospitals, this study can open up a way to address the scarcity of intra-oral scanner data to avail a large number of implant patients with an effective guide. The success rate of this study will encourage us not only to prioritize guided surgeries over free-hand practices or guide-pin-assisted surgeries but also to significantly impact the execution of implant surgeries in developing countries.
- Conditions
- Partially Edentulous Mandible, Dental Implantation
- Being tested
- Surgical Guide, Guide-pin-assisted Freehand surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical GuideDevice
For this case, after the patient is given anesthesia, the guide will be placed on the teeth. All the drillings will be performed through the guided path. There will be no need for raising flap according to flapless surgery. At the end of the operation, the operation site will be checked and hemostasis will be provided. The operator will record the operation in the source documentation. 2 ± 1 days later, a postoperative CT scan will be taken. A follow-up visit will be due 14 ± 2 weeks later, after the osseointegration period.
Guide-pin-assisted Freehand surgeryProcedure or surgery
The regular protocol of the implant surgery will be followed. Before the surgery begins, the patient will be given anesthesia to ensure they are comfortable and pain-free during the procedure. Doctors will go through the digital planning to understand the desired angulation. Then the bony bed will be prepared raising flap from targeted area. Then a guide-pin will be inserted by drilling and through radiographic image the direction will be confirmed. Following the hole of the guide-pin, the implant will be inserted. At the end of the operation, the raised flap will be sewn and hemostasis will be provided. The operator records the operation in the source documentation. 2 ± 1 days later, a postoperative CT scan will be taken. A follow-up visit will be due 14 ± 2 weeks later, after the osseointegration period.
| Study group | Role | What they receive |
|---|---|---|
| FREE HAND (GUIDE-PIN-assisted) | Active comparator | Not described Receives: Procedure: Guide-pin-assisted Freehand surgery |
| FULL GUIDED | Experimental | Not described Receives: Device: Surgical Guide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Angular deviation
The angle formed by the primary axis of the proposed digital implant and the actual implant as put, stated in degrees.
Measured: 3 months
Secondary outcomes (2)
Apical deviation
The deviation of the implant's apical point from the anticipated apical position in three dimensions, measured in millimeters.
Measured: 3 months
Coronal deviation
The deviation of the implant's coronal point from the anticipated coronal position in three dimensions, measured in millimeters.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2023
- Study start23 Aug 2023
- Primary completion30 Apr 2024 (estimated)
- Study completion31 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Partially Edentulous MandibleStudies 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
- Model description
- Parallel Assignment
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dhaka Dental College and Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Bangladesh University of Engineering and Technology
- Responsible party
- Principal investigator, Dr. Md. Al-Amin Sarkar, Dhaka Dental College and Hospital
- Investigators
- Dr. Md Al-Amin Sarkar, BDS, FCPS (Prosthodontics), Principal investigator, Dhaka Dental College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05983718
- Sponsor's protocol ID
- BME-BUET-DDCH-001
- Status last verified
- Sep 2023
- First submitted
- 2 Aug 2023
- Last updated
- 26 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Albrektsson T, Dahl E, Enbom L, Engevall S, Engquist B, Eriksson AR, Feldmann G, Freiberg N, Glantz PO, Kjellman O, et al. Osseointegrated oral implants. A Swedish multicenter study of 8139 consecutively inserted Nobelpharma implants. J Periodontol. 1988 May;59(5):287-96. doi: 10.1902/jop.1988.59.5.287.
PubMed 3290429Bacchetti P, Leung JM. Sample size calculations in clinical research. Anesthesiology. 2002 Oct;97(4):1028-9; author reply 1029-32. doi: 10.1097/00000542-200210000-00050. No abstract available.
PubMed 12357184Cassetta M, Stefanelli LV, Giansanti M, Di Mambro A, Calasso S. Depth deviation and occurrence of early surgical complications or unexpected events using a single stereolithographic surgi-guide. Int J Oral Maxillofac Surg. 2011 Dec;40(12):1377-87. doi: 10.1016/j.ijom.2011.09.009. Epub 2011 Oct 15.
PubMed 22001378Coravos A, Goldsack JC, Karlin DR, Nebeker C, Perakslis E, Zimmerman N, Erb MK. Digital Medicine: A Primer on Measurement. Digit Biomark. 2019 May 9;3(2):31-71. doi: 10.1159/000500413. eCollection 2019 May-Aug.
PubMed 32095767Geng W, Liu C, Su Y, Li J, Zhou Y. Accuracy of different types of computer-aided design/computer-aided manufacturing surgical guides for dental implant placement. Int J Clin Exp Med. 2015 Jun 15;8(6):8442-9. eCollection 2015.
PubMed 26309497Israelson H, Plemons JM, Watkins P, Sory C. Barium-coated surgical stents and computer-assisted tomography in the preoperative assessment of dental implant patients. Int J Periodontics Restorative Dent. 1992;12(1):52-61.
PubMed 1526711Jacobs R, Adriansens A, Verstreken K, Suetens P, van Steenberghe D. Predictability of a three-dimensional planning system for oral implant surgery. Dentomaxillofac Radiol. 1999 Mar;28(2):105-11. doi: 10.1038/sj/dmfr/4600419.
PubMed 10522199Jacobs R, Adriansens A, Naert I, Quirynen M, Hermans R, Van Steenberghe D. Predictability of reformatted computed tomography for pre-operative planning of endosseous implants. Dentomaxillofac Radiol. 1999 Jan;28(1):37-41. doi: 10.1038/sj.dmfr.4600403.
PubMed 10202477Kernen F, Benic GI, Payer M, Schar A, Muller-Gerbl M, Filippi A, Kuhl S. Accuracy of Three-Dimensional Printed Templates for Guided Implant Placement Based on Matching a Surface Scan with CBCT. Clin Implant Dent Relat Res. 2016 Aug;18(4):762-8. doi: 10.1111/cid.12348. Epub 2015 Apr 28.
PubMed 25923363Kiatkroekkrai P, Takolpuckdee C, Subbalekha K, Mattheos N, Pimkhaokham A. Accuracy of implant position when placed using static computer-assisted implant surgical guides manufactured with two different optical scanning techniques: a randomized clinical trial. Int J Oral Maxillofac Surg. 2020 Mar;49(3):377-383. doi: 10.1016/j.ijom.2019.08.019. Epub 2019 Sep 20.
PubMed 31543382Lin CC, Ishikawa M, Maida T, Cheng HC, Ou KL, Nezu T, Endo K. Stereolithographic Surgical Guide with a Combination of Tooth and Bone Support: Accuracy of Guided Implant Surgery in Distal Extension Situation. J Clin Med. 2020 Mar 5;9(3):709. doi: 10.3390/jcm9030709.
PubMed 32151043Schneider D, Marquardt P, Zwahlen M, Jung RE. A systematic review on the accuracy and the clinical outcome of computer-guided template-based implant dentistry. Clin Oral Implants Res. 2009 Sep;20 Suppl 4:73-86. doi: 10.1111/j.1600-0501.2009.01788.x.
PubMed 19663953Verstreken K, Van Cleynenbreugel J, Martens K, Marchal G, van Steenberghe D, Suetens P. An image-guided planning system for endosseous oral implants. IEEE Trans Med Imaging. 1998 Oct;17(5):842-52. doi: 10.1109/42.736056.
PubMed 9874310Younes F, Cosyn J, De Bruyckere T, Cleymaet R, Bouckaert E, Eghbali A. A randomized controlled study on the accuracy of free-handed, pilot-drill guided and fully guided implant surgery in partially edentulous patients. J Clin Periodontol. 2018 Jun;45(6):721-732. doi: 10.1111/jcpe.12897. Epub 2018 May 10.
PubMed 29608793D'haese J, Van De Velde T, Komiyama A, Hultin M, De Bruyn H. Accuracy and complications using computer-designed stereolithographic surgical guides for oral rehabilitation by means of dental implants: a review of the literature. Clin Implant Dent Relat Res. 2012 Jun;14(3):321-35. doi: 10.1111/j.1708-8208.2010.00275.x. Epub 2010 May 11.
PubMed 20491822
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Positional Accuracy in Dental Implant Placement Between Conventionally Used Guide Pin and 3D Printed Surgical Guide Developed From CBCT
- ClinicalTrials.gov ID
- NCT05983718
- Acronym / sponsor ID
- BME-BUET-DDCH-001
- Conditions
- Partially Edentulous Mandible, Dental Implantation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Dhaka Dental College and HospitalUniversity, hospital or other
- Collaborators
- Bangladesh University of Engineering and Technology
- Study start
- 23 Aug 2023 (actual)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 9 Aug 2023 (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.
This is a randomized controlled study that aims to compare the accuracy between full-guided with guide-pin-assisted free-hand dental implant surgeries. The basis of evaluation in each case is the comparison of the preoperative digital plan with the actual postoperative status.
Detailed description
Dental implant surgery is a treatment that replaces damaged or missing teeth with artificial teeth that are aesthetically and functionally similar to natural teeth. For a successful implant surgery, it is necessary to use digital planning software in conjunction with a cone-beam CT scan and a custom-made 3D-printed surgical guide. In developing countries like Bangladesh, surgical guide-assisted dental implant surgery is absent. Doctors attend implant surgeries relying on their visual assessment from x-ray images or CBCT data. They need to cut the outer soft tissue, expose the bone, and use a guide pin to confirm the direction and location. Then they perform implant surgery following the hole created by the guide pin, similar to free-hand surgery. But the overall procedure is still highly invasive and has low accuracy.
Free-hand implant surgeries are still in practice everywhere. The application of a guide pin has been observed in some places to enhance the situation. A guide pin helps an operator recognize the position and angle of an alveolar bone when forming an implantation hole in the alveolar bone to insert an implant into the alveolar bone. Doctors insert a guide pin to the implant site with minimal incision and then confirm the desired direction and location with a radiographic image. However, we need a proper clinical evaluation to compare fully-guided surgeries to guide-pin-assisted surgeries to understand the accuracy of both processes.
The accuracy of the pre-planned 3D-printed surgical guide is well established. Introducing dental software and guided surgery has already achieved higher acceptance in implant surgery. Several patients from several privileged parts of the world benefit from surgical guides. But the usual design convention includes intraoral scanner data with CBCT. However, intraoral scanners are still unavailable in many dental hospitals. The study is designed to address the precision of dental implant surgeries worldwide, especially where the intraoral scanner is not present. In our research, we will focus on partially edentulous patients. And our design procedure will not be dependent on intra-oral scanner data. As partially edentulous patients are higher in number and CBCT machines readily available in hospitals, this study can open up a way to address the scarcity of intra-oral scanner data to avail a large number of implant patients with an effective guide. The success rate of this study will encourage us not only to prioritize guided surgeries over free-hand practices or guide-pin-assisted surgeries but also to significantly impact the execution of implant surgeries in developing countries.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| FREE HAND (GUIDE-PIN-assisted) | Active comparator | Procedure: Guide-pin-assisted Freehand surgery |
| FULL GUIDED | Experimental | Device: Surgical Guide |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients of age between 18 to 75 and of any gender
- Patient fit for implantation (satisfactory soft and hard tissue conditions and occlusion)
- Partially edentulous patient
Key exclusion criteria (13 listed)
- Patient with pregnancy
- Patient with uncontrolled diabetes mellitus.
- Patient who needed dentoalveolar or associated soft tissue reconstruction procedure
- Patient taking bisphosphonate or have any history of systemic or local bone disease
- Recent extracted sites
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 |
|---|---|---|
| Surgical GuideFor this case, after the patient is given anesthesia, the guide will be placed on the teeth. All the drillings will be performed through the guided path. There will be no need for raising flap according to flapless surgery. At the end of the operation, the operation site will be checked and hemostasis will be provided. The operator will record the operation in the source documentation. 2 ± 1 days later, a postoperative CT scan will be taken. A follow-up visit will be due 14 ± 2 weeks later, after the osseointegration period. | Device | FULL GUIDED |
| Guide-pin-assisted Freehand surgeryThe regular protocol of the implant surgery will be followed. Before the surgery begins, the patient will be given anesthesia to ensure they are comfortable and pain-free during the procedure. Doctors will go through the digital planning to understand the desired angulation. Then the bony bed will be prepared raising flap from targeted area. Then a guide-pin will be inserted by drilling and through radiographic image the direction will be confirmed. Following the hole of the guide-pin, the implant will be inserted. At the end of the operation, the raised flap will be sewn and hemostasis will be provided. The operator records the operation in the source documentation. 2 ± 1 days later, a postoperative CT scan will be taken. A follow-up visit will be due 14 ± 2 weeks later, after the osseointegration period. | Procedure or surgery | FREE HAND (GUIDE-PIN-assisted) |
Primary outcome
Angular deviation
Time frame: 3 months
The angle formed by the primary axis of the proposed digital implant and the actual implant as put, stated in degrees.
2 secondary outcomes
Apical deviation
Time frame: 3 months
Coronal deviation
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2023.
- Background: PubMed 3290429Albrektsson T, Dahl E, Enbom L, Engevall S, Engquist B, Eriksson AR, Feldmann G, Freiberg N, Glantz PO, Kjellman O, et al. Osseointegrated oral implants. A Swedish multicenter study of 8139 consecutively inserted Nobelpharma implants. J Periodontol. 1988 May;59(5):287-96. doi: 10.1902/jop.1988.59.5.287.
- Background: PubMed 12357184Bacchetti P, Leung JM. Sample size calculations in clinical research. Anesthesiology. 2002 Oct;97(4):1028-9; author reply 1029-32. doi: 10.1097/00000542-200210000-00050. No abstract available.
- Background: PubMed 22001378Cassetta M, Stefanelli LV, Giansanti M, Di Mambro A, Calasso S. Depth deviation and occurrence of early surgical complications or unexpected events using a single stereolithographic surgi-guide. Int J Oral Maxillofac Surg. 2011 Dec;40(12):1377-87. doi: 10.1016/j.ijom.2011.09.009. Epub 2011 Oct 15.
- Background: PubMed 32095767Coravos A, Goldsack JC, Karlin DR, Nebeker C, Perakslis E, Zimmerman N, Erb MK. Digital Medicine: A Primer on Measurement. Digit Biomark. 2019 May 9;3(2):31-71. doi: 10.1159/000500413. eCollection 2019 May-Aug.
- Background: PubMed 26309497Geng W, Liu C, Su Y, Li J, Zhou Y. Accuracy of different types of computer-aided design/computer-aided manufacturing surgical guides for dental implant placement. Int J Clin Exp Med. 2015 Jun 15;8(6):8442-9. eCollection 2015.
- Background: PubMed 1526711Israelson H, Plemons JM, Watkins P, Sory C. Barium-coated surgical stents and computer-assisted tomography in the preoperative assessment of dental implant patients. Int J Periodontics Restorative Dent. 1992;12(1):52-61.
- Background: PubMed 10522199Jacobs R, Adriansens A, Verstreken K, Suetens P, van Steenberghe D. Predictability of a three-dimensional planning system for oral implant surgery. Dentomaxillofac Radiol. 1999 Mar;28(2):105-11. doi: 10.1038/sj/dmfr/4600419.
- Background: PubMed 10202477Jacobs R, Adriansens A, Naert I, Quirynen M, Hermans R, Van Steenberghe D. Predictability of reformatted computed tomography for pre-operative planning of endosseous implants. Dentomaxillofac Radiol. 1999 Jan;28(1):37-41. doi: 10.1038/sj.dmfr.4600403.
- Background: PubMed 25923363Kernen F, Benic GI, Payer M, Schar A, Muller-Gerbl M, Filippi A, Kuhl S. Accuracy of Three-Dimensional Printed Templates for Guided Implant Placement Based on Matching a Surface Scan with CBCT. Clin Implant Dent Relat Res. 2016 Aug;18(4):762-8. doi: 10.1111/cid.12348. Epub 2015 Apr 28.
- Background: PubMed 31543382Kiatkroekkrai P, Takolpuckdee C, Subbalekha K, Mattheos N, Pimkhaokham A. Accuracy of implant position when placed using static computer-assisted implant surgical guides manufactured with two different optical scanning techniques: a randomized clinical trial. Int J Oral Maxillofac Surg. 2020 Mar;49(3):377-383. doi: 10.1016/j.ijom.2019.08.019. Epub 2019 Sep 20.
- Background: PubMed 32151043Lin CC, Ishikawa M, Maida T, Cheng HC, Ou KL, Nezu T, Endo K. Stereolithographic Surgical Guide with a Combination of Tooth and Bone Support: Accuracy of Guided Implant Surgery in Distal Extension Situation. J Clin Med. 2020 Mar 5;9(3):709. doi: 10.3390/jcm9030709.
- Background: PubMed 19663953Schneider D, Marquardt P, Zwahlen M, Jung RE. A systematic review on the accuracy and the clinical outcome of computer-guided template-based implant dentistry. Clin Oral Implants Res. 2009 Sep;20 Suppl 4:73-86. doi: 10.1111/j.1600-0501.2009.01788.x.
- 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. This study is not recruiting at the moment.
Dr. Md Al-Amin Sarkar, BDS, FCPS (Prosthodontics) principal investigator
Dhaka Dental College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical Guide and Guide-pin-assisted Freehand surgery in people with Partially Edentulous Mandible and Dental Implantation, run by Dhaka Dental College and Hospital at 1 site in Bangladesh.
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 3 inclusion and 13 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 26 Sep 2023. 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 Bangladesh. 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 Dr. Md Al-Amin Sarkar, BDS, FCPS (Prosthodontics) (+8801715748863, dr.sarkar.bds@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Angular deviation (time frame: 3 months). 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 NCT05983718, which also lists 16 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 26 Sep 2023.