Implant ComplicationNCT06917638
Dental Implant Stability Placed in Healed Bony Sites Using Oversized Drilling Versus Conventional Drilling Protocol
A study testing implant placment in people with Implant Complication, run by Cairo University at 1 site in Egypt.
Trial summary
The goal of this [type of study: clinical trial] is to [investigate the influence of Oversized Drilling Versus Traditional for implant Stability and Crestal Bone Loss.] in [ Healthy Patient aged between 20 and 60 years with one missing tooth in the posterior mandible with sufficient bone dimensions]. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Implant Complication
- What is being tested?
- implant placment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteEgypt
- Study dates
- 8 Nov 2023to 20 May 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with a single missing tooth in the posterior region of the mandibular arch.
- Bone dimensions buccolingual (not less than 6mm) and apicocoronal (not less than 10mm)
- Patients with healthy systemic condition. (Brightman. 1994)
- Patients aged from 20 to 60 years old.
- Good oral hygiene. (Wiesner et al. 2010)
- Accepts 6 months follow-up period (cooperative patients)
Who cannot join
- Patients with signs of acute infection related to the area of interest.
- Patients with habits that may jeopardize the implant longevity and affect the results of the study such as parafunctional habits or alcoholism (Lobbezoo et al. 2006).
- Smokers (Bruno Ramos Chrcanovic et al. 2015) (25).
- Pregnant women
- Patients on medication that may interfere with healing (corticosteroids, bisphosphonate, Chemo/radio therapy).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of Dental Implant Stability Placed in Healed Bony Sites Using Oversized Drilling Versus Conventional Drilling Protocol: A Randomized Controlled Clinical Trial
The goal of this [type of study: clinical trial] is to [investigate the influence of Oversized Drilling Versus Traditional for implant Stability and Crestal Bone Loss.] in [ Healthy Patient aged between 20 and 60 years with one missing tooth in the posterior mandible with sufficient bone dimensions].
The main question[s] it aims to answer are:
Read more
the influence of oversized drilling versus traditional drilling in the mandibular arch, in terms of implant stability and crestal bone levels. The effects of oversized protocol have not been fully explored on the more compact mandibular bone.
Participants will Control Group: Under-sized drilling group (UD):
Manufacturer-recommended implant osteotomy preparation will be done according to the manufacturer guidelines with the final drill the same diameter of the implant. Intervention Group: oversized drilling (OD) Osteotomy preparations for the oversized drilling group will include an extra drill, which will be 0.2mm wider than the diameter of the implant.
- Once the osteotomy is ready, the appropriate implant will be placed manually at first and then progressed using a ratchet.
- After the implant is correctly placed, a smart peg will be attached to the implant via hand screwing, to measure its stability using Ostell and four readings will be recorded: a mesial, distal, buccal and lingual reading.
- The smart peg will then be removed and will be replaced with a healing collar above the gingival margin.
- The flap will then be sutured back to its original position around the healing collar with an interrupted suture.
- A standardized digital periapical radiograph will be taken using a radiographic holder and a custom-made radiographic stent to determine the initial crestal bone level.
Read the detailed description
- Pre-operative evaluation
Clinical examination:
- Evaluation of the general condition of the oral cavity of the patients will be performed to make sure it will comply with the criteria required to be enrolled in the study in terms of oral hygiene, pathological conditions, and inter-arch space.
- When the patients meet the clinical selection criteria, radiographic examination will follow.
Radiographic examination:
- A pre-operative periapical x-ray will be performed for each of the patients who met the clinical selection criteria to increase chances of eligibility prior to a pre-operative Cone Beam Computed Tomography (CBCT). This will be done to avoid unnecessary extra expenses of a CBCT and unnecessary radiation exposure.
- A pre-operative CBCT will be performed for each of the patients who met the clinical and primary radiographic selection criteria to ensure eligibility prior to the surgery.
From the obtained CBCT, the bone height, width and density will be determined.
- Once the patients passes both the clinical and radiographic selection criteria, they will be enrolled by the investigator into the study.
- The enrolled patients will then be provided with a full explanation of the aim and benefits of the study in plain language, then, given the chance to have an informed discussion with the investigator.
- Once the patients approve the intervention and agree to comply with the study guidelines, they will sign a written informed consent form translated in Arabic.
Patient preparation:
- The enrolled participants will be prepared 2 weeks prior to the surgery. This will include professional scaling, oral hygiene instructions and treatment of any caries or defective fillings present around the surgical site.
- Diagnostic impressions will be taken using alginate impression material during the preparation phase.
- After the cast is poured out, a radiographic stent will be created at the area of interest using cold cure acrylic material. This will be done by the aid of an x-ray holder consisting of an acrylic customized bite block, a metallic indicator arm and a radiographic rim. The aim of this step is to standardize the position of the digital xray for each site in order to ensure reproducibility between follow ups when measuring crestal bone loss.
- Surgical procedure:
- After local anaesthesia, a crestal incision will be performed at the site using a 15c blade followed by full thickness mucoperiosteal flap elevation to expose the underlying bone. A periodontal probe will then be used to help locate the correct point of drilling. This will be done by leaving a margin(1mm) between the buccal plate and the osteotomy, a margin(1mm) between the lingual plate and the osteotomy, A margin(1.5mm) between the neighboring tooth and the osteotomy.
- A round bur will used to mark the point of drilling located by the periodontal probe.
- The drilling (1200 rpm) will then performed under copious irrigation with normal saline sequentially according to the manufacturer's instructions to reach the final drill corresponding to the implant size.
- Allocation concealment will be broken at this point to assign the patient into one of two groups:
Control Group: Under-sized drilling group (UD):
Manufacturer-recommended implant osteotomy preparation will be done according to the manufacturer guidelines with the final drill the same diameter of the implant. Intervention Group: oversized drilling (OD) Osteotomy preparations for the oversized drilling group will include an extra drill, which will be 0.2mm wider than the diameter of the implant.
- Once the osteotomy is ready, the appropriate implant will be placed manually at first and then progressed using a ratchet.
- After the implant is correctly placed, a smart peg will be attached to the implant via hand screwing, to measure its stability using Ostell and four readings will be recorded: a mesial, distal, buccal and lingual reading.
- The smart peg will then be removed and will be replaced with a healing collar above the gingival margin.
- The flap will then be sutured back to its original position around the healing collar with an interrupted suture.
- A standardized digital periapical radiograph will be taken using a radiographic holder and a custom-made radiographic stent to determine the initial crestal bone level.
Postoperative instructions and follow up:
The patient will be instructed to take:
- Antibiotics (Amoxicillin 1g twice daily for 5 days) to prevent any chance of infection. (Eugenio Romeo et al, 2014).
- Anti-inflammatory drugs (NSAIDS; Ibuprofen 600mg three times daily for 5 days) to avoid any chance of oedema or pain or swelling (Francesco pieri et al, 2012).
- Antiseptic mouth rinse (0.12% Chlorhexidine oral rinse will be prescribed for 60 seconds two times a day for 14 days. (Jun Yu et al, 2015)
The patient will be instructed to:
- Apply an ice pack to the treated area for the first 24 hours. (Francesco pieri et al, 2012).
- Avoid any brushing or trauma to the surgical site for one week. (Francesco pieri et al, 2012). The patient will be instructed to come in for weekly follow ups over the course of the following 3 months after implant placement for recording Ostell readings. After 6 months following the implant placement, (Paolantoni et al. 2013) healing collar will be removed, and impressions (indirect, open or closed tray technique) will be taken to fabricate the final crowns followed by crown placement.
- Conditions
- Implant Complication
- Being tested
- implant placment
- Keywords
- implant stability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
implant placmentProcedure or surgery
- Crestal incision followed by full thickness mucoperiosteal flap elevation.
- Drilling of the implant according to the manufacturer's instructions to reach the final drill corresponding to the implant size.
- Allocation concealment will be broken at this point to assign the patient into one of two groups:
Control Group: osteotomy preparation the same diameter of the implant. Intervention: oversized drilling:Osteotomy preparations will include an extra drill,(0.2mm) wider than the diameter of the implant.
- A smart peg will then be attached to the implant, to measure its stability using Ostell and three readings will be recorded:occlusal buccal and lingual reading.
- A healing collar will then be place over the implant, then simple intrerupted suture
- A standardized digital periapical radiograph will be taken using a radiographic holder and a custom-made radiographic stent to determine the initial crestal bone level.
| Study group | Role | What they receive |
|---|---|---|
| Control Group: Under-sized drilling group (UD) | Active comparator | Manufacturer-recommended implant osteotomy preparation will be done according to the manufacturer guidelines with the final drill the same diameter of the implant. Receives: Procedure: implant placment |
| Intervention Group: oversized drilling (OD) | Active comparator | Osteotomy preparations for the oversized drilling group will include an extra drill, which will be 0.2mm wider than the diameter of the implant. Receives: Procedure: implant placment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant stability quotient (ISQ)
resonance frequency analysis
Measured: 1 week, 2 weeks, 3 weeks, 4 weeks, 6 weeks, 8 weeks, and 12 weeks postoperatively.
Secondary outcomes (1)
• crestal bone levels (day of the surgery (baseline), at 3 and 6 months postoperatively) • pain • swelling • satisfaction • implant survival
parallel technique periapical radiography
VAS Categorical scale Questionnaire Categorical scale
Measured: (day of the surgery (baseline), at 3 and 6 months postoperatively)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study start8 Nov 2023
- Primary completion20 May 2025 (estimated)
- Study completion20 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Implant ComplicationStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ِAmr Said Ahmed el sayed el shikh, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06917638
- Sponsor's protocol ID
- https://cu.edu.eg/ar/Home
- Status last verified
- Mar 2025
- First submitted
- 17 Mar 2024
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Seleem A, Tawfik OK, El-Nahass H. Evaluation of Oversized Drilling on Implant Survival and Stability Versus Traditional Drilling Technique: A Randomized Clinical Trial. Int J Oral Maxillofac Implants. 2021 Jul-Aug;36(4):771-778. doi: 10.11607/jomi.8777.
PubMed 34411219
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Dental Implant Stability Placed in Healed Bony Sites Using Oversized Drilling Versus Conventional Drilling Protocol: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06917638
- Acronym / sponsor ID
- https://cu.edu.eg/ar/Home
- Conditions
- Implant Complication
- Keywords
- implant stability
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 8 Nov 2023 (actual)
- Primary completion
- 20 May 2025 (estimated)
- Study completion
- 20 May 2026 (estimated)
- First posted
- 8 Apr 2025 (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.
The goal of this [type of study: clinical trial] is to [investigate the influence of Oversized Drilling Versus Traditional for implant Stability and Crestal Bone Loss.] in [ Healthy Patient aged between 20 and 60 years with one missing tooth in the posterior mandible with sufficient bone dimensions].
The main question[s] it aims to answer are:
the influence of oversized drilling versus traditional drilling in the mandibular arch, in terms of implant stability and crestal bone levels. The effects of oversized protocol have not been fully explored on the more compact mandibular bone.
Participants will Control Group: Under-sized drilling group (UD):
Manufacturer-recommended implant osteotomy preparation will be done according to the manufacturer guidelines with the final drill the same diameter of the implant. Intervention Group: oversized drilling (OD) Osteotomy preparations for the oversized drilling group will include an extra drill, which will be 0.2mm wider than the diameter of the implant.
- Once the osteotomy is ready, the appropriate implant will be placed manually at first and then progressed using a ratchet.
- After the implant is correctly placed, a smart peg will be attached to the implant via hand screwing, to measure its stability using Ostell and four readings will be recorded: a mesial, distal, buccal and lingual reading.
- The smart peg will then be removed and will be replaced with a healing collar above the gingival margin.
- The flap will then be sutured back to its original position around the healing collar with an interrupted suture.
- A standardized digital periapical radiograph will be taken using a radiographic holder and a custom-made radiographic stent to determine the initial crestal bone level.
Detailed description
- Pre-operative evaluation
Clinical examination:
- Evaluation of the general condition of the oral cavity of the patients will be performed to make sure it will comply with the criteria required to be enrolled in the study in terms of oral hygiene, pathological conditions, and inter-arch space.
- When the patients meet the clinical selection criteria, radiographic examination will follow.
Radiographic examination:
- A pre-operative periapical x-ray will be performed for each of the patients who met the clinical selection criteria to increase chances of eligibility prior to a pre-operative Cone Beam Computed Tomography (CBCT). This will be done to avoid unnecessary extra expenses of a CBCT and unnecessary radiation exposure.
- A pre-operative CBCT will be performed for each of the patients who met the clinical and primary radiographic selection criteria to ensure eligibility prior to the surgery.
From the obtained CBCT, the bone height, width and density will be determined.
- Once the patients passes both the clinical and radiographic selection criteria, they will be enrolled by the investigator into the study.
- The enrolled patients will then be provided with a full explanation of the aim and benefits of the study in plain language, then, given the chance to have an informed discussion with the investigator.
- Once the patients approve the intervention and agree to comply with the study guidelines, they will sign a written informed consent form translated in Arabic.
Patient preparation:
- The enrolled participants will be prepared 2 weeks prior to the surgery. This will include professional scaling, oral hygiene instructions and treatment of any caries or defective fillings present around the surgical site.
- Diagnostic impressions will be taken using alginate impression material during the preparation phase.
- After the cast is poured out, a radiographic stent will be created at the area of interest using cold cure acrylic material. This will be done by the aid of an x-ray holder consisting of an acrylic customized bite block, a metallic indicator arm and a radiographic rim. The aim of this step is to standardize the position of the digital xray for each site in order to ensure reproducibility between follow ups when measuring crestal bone loss.
- Surgical procedure:
- After local anaesthesia, a crestal incision will be performed at the site using a 15c blade followed by full thickness mucoperiosteal flap elevation to expose the underlying bone. A periodontal probe will then be used to help locate the correct point of drilling. This will be done by leaving a margin(1mm) between the buccal plate and the osteotomy, a margin(1mm) between the lingual plate and the osteotomy, A margin(1.5mm) between the neighboring tooth and the osteotomy.
- A round bur will used to mark the point of drilling located by the periodontal probe.
- The drilling (1200 rpm) will then performed under copious irrigation with normal saline sequentially according to the manufacturer's instructions to reach the final drill corresponding to the implant size.
- Allocation concealment will be broken at this point to assign the patient into one of two groups:
Control Group: Under-sized drilling group (UD):
Manufacturer-recommended implant osteotomy preparation will be done according to the manufacturer guidelines with the final drill the same diameter of the implant. Intervention Group: oversized drilling (OD) Osteotomy preparations for the oversized drilling group will include an extra drill, which will be 0.2mm wider than the diameter of the implant.
- Once the osteotomy is ready, the appropriate implant will be placed manually at first and then progressed using a ratchet.
- After the implant is correctly placed, a smart peg will be attached to the implant via hand screwing, to measure its stability using Ostell and four readings will be recorded: a mesial, distal, buccal and lingual reading.
- The smart peg will then be removed and will be replaced with a healing collar above the gingival margin.
- The flap will then be sutured back to its original position around the healing collar with an interrupted suture.
- A standardized digital periapical radiograph will be taken using a radiographic holder and a custom-made radiographic stent to determine the initial crestal bone level.
Postoperative instructions and follow up:
The patient will be instructed to take:
- Antibiotics (Amoxicillin 1g twice daily for 5 days) to prevent any chance of infection. (Eugenio Romeo et al, 2014).
- Anti-inflammatory drugs (NSAIDS; Ibuprofen 600mg three times daily for 5 days) to avoid any chance of oedema or pain or swelling (Francesco pieri et al, 2012).
- Antiseptic mouth rinse (0.12% Chlorhexidine oral rinse will be prescribed for 60 seconds two times a day for 14 days. (Jun Yu et al, 2015)
The patient will be instructed to:
- Apply an ice pack to the treated area for the first 24 hours. (Francesco pieri et al, 2012).
- Avoid any brushing or trauma to the surgical site for one week. (Francesco pieri et al, 2012). The patient will be instructed to come in for weekly follow ups over the course of the following 3 months after implant placement for recording Ostell readings. After 6 months following the implant placement, (Paolantoni et al. 2013) healing collar will be removed, and impressions (indirect, open or closed tray technique) will be taken to fabricate the final crowns followed by crown placement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group: Under-sized drilling group (UD) | Active comparator | Procedure: implant placmentManufacturer-recommended implant osteotomy preparation will be done according to the manufacturer guidelines with the final drill the same diameter of the implant. |
| Intervention Group: oversized drilling (OD) | Active comparator | Procedure: implant placmentOsteotomy preparations for the oversized drilling group will include an extra drill, which will be 0.2mm wider than the diameter of the implant. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients with a single missing tooth in the posterior region of the mandibular arch.
- Bone dimensions buccolingual (not less than 6mm) and apicocoronal (not less than 10mm)
- Patients with healthy systemic condition. (Brightman. 1994)
- Patients aged from 20 to 60 years old.
- Good oral hygiene. (Wiesner et al. 2010)
Key exclusion criteria (5 listed)
- Patients with signs of acute infection related to the area of interest.
- Patients with habits that may jeopardize the implant longevity and affect the results of the study such as parafunctional habits or alcoholism (Lobbezoo et al. 2006).
- Smokers (Bruno Ramos Chrcanovic et al. 2015) (25).
- Pregnant women
- Patients on medication that may interfere with healing (corticosteroids, bisphosphonate, Chemo/radio therapy).
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 |
|---|---|---|
| implant placment* Crestal incision followed by full thickness mucoperiosteal flap elevation. * Drilling of the implant according to the manufacturer's instructions to reach the final drill corresponding to the implant size. * Allocation concealment will be broken at this point to assign the patient into one of two groups: Control Group: osteotomy preparation the same diameter of the implant. Intervention: oversized drilling:Osteotomy preparations will include an extra drill,(0.2mm) wider than the diameter of the implant. * A smart peg will then be attached to the implant, to measure its stability using Ostell and three readings will be recorded:occlusal buccal and lingual reading. * A healing collar will then be place over the implant, then simple intrerupted suture * A standardized digital periapical radiograph will be taken using a radiographic holder and a custom-made radiographic stent to determine the initial crestal bone level. | Procedure or surgery | Control Group: Under-sized drilling group (UD), Intervention Group: oversized drilling (OD) |
Primary outcome
Implant stability quotient (ISQ)
Time frame: 1 week, 2 weeks, 3 weeks, 4 weeks, 6 weeks, 8 weeks, and 12 weeks postoperatively.
resonance frequency analysis
1 secondary outcome
• crestal bone levels (day of the surgery (baseline), at 3 and 6 months postoperatively) • pain • swelling • satisfaction • implant survival
Time frame: (day of the surgery (baseline), at 3 and 6 months postoperatively)
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 8 Apr 2025.
- Results publication: PubMed 34411219Seleem A, Tawfik OK, El-Nahass H. Evaluation of Oversized Drilling on Implant Survival and Stability Versus Traditional Drilling Technique: A Randomized Clinical Trial. Int J Oral Maxillofac Implants. 2021 Jul-Aug;36(4):771-778. doi: 10.11607/jomi.8777.
- Oversized implantsLink provided by the sponsor.
Related trials for Implant Complication
Not yet recruiting
Safety Assessment of Placing a Single Dental Implant Without Antibiotic Prophylaxis in Simple Cases: A Pilot Study
Tooth Loss and Rehabillitation, Dental Implant Failure
RecruitingObservational study
Clinical and Radiographic Evaluation of Dentsply Sirona PrimeTaper Implants
Dental Implants
Recruiting
Post Market Study for VasQ, an External Support Implant for Arteriovenous Fistula
End Stage Renal Disease
Active, not recruiting
THE EFFECT OF FILLING MATERIAL AND PLACEMENT TECHNIQUE ON POSTOPERATIVE PAIN IN NON-SURGICAL ENDODONTIC RETREATMENT: A RANDOMIZED CLINICAL TRIAL
Retreatment, Endodontic Diseases
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing implant placment in people with Implant Complication, run by Cairo University at 1 site in Egypt.
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: under way, not looking for participants, as of the sponsor's last update on 8 Apr 2025. 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 Egypt. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant stability quotient (ISQ) (time frame: 1 week, 2 weeks, 3 weeks, 4 weeks, 6 weeks, 8 weeks, and 12 weeks postoperatively.). 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 NCT06917638, which also lists 1 linked publication.
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 8 Apr 2025.