Maxillary Sinus AugmentationNCT05735613
Efficacy of Different Techniques of Crestal Sinus Lifting
A study testing osteotome crestal sinus lifting, osseodensification crestal sinus lifting and piezoelectric crestal sinus lifting in people with Maxillary Sinus Augmentation, run by Al-Azhar University at 1 site in Egypt.
Trial summary
Twenty one patients with deficient posterior maxilla and alveolar bone height ≤ 5mm were included.Those patients randomly divided into 3 equal groups: 1. Group 1: 7 patients treated by osteotome closed sinus lift with bone grafting (xenograft) and implant placement. 2. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Maxillary Sinus Augmentation
- What is being tested?
- osteotome crestal sinus lifting, osseodensification crestal sinus lifting and piezoelectric crestal sinus lifting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jan 2020to 28 Apr 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Young and adult patients of both sexes.
- Patients exhibit class C residual bone height according to ABC sinus augmentation classification.(18)
- The edentulous ridges are covered with mucoperiosteum free from signs of inflammation, ulceration or scar tissue.
- Remaining natural teeth have good periodontal tissue support.
- Occlusion showing sufficient inter-arch and intra-arch spaces for future prosthesis.
Who cannot join
- Patients with systemic conditions that could influence the outcome of the therapy as: Pregnancy and Heavy smokers
- Patients with systemic disease that may affect bone quality.
- Uncooperative patients
- Patients with active periodontal disease.
- Patients with neglected oral hygiene.
- Patients with limited mouth opening and unfavorable intermaxillary arch space.
- Patients with maxillary sinus disease or previous sinus surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of Different Techniques of Crestal Sinus Lifting to Place Dental Implant Into Prosterior Maxilla of Deficient Height: Randomised Clinical Trial
Twenty one patients with deficient posterior maxilla and alveolar bone height ≤ 5mm were included.Those patients randomly divided into 3 equal groups:
- Group 1: 7 patients treated by osteotome closed sinus lift with bone grafting (xenograft) and implant placement.
- Group 2: 7 patients treated by densah burs(Versah, Jackson, MI, USA) sinus lift with bone grafting (xenograft) and implant placement.
- Group 3: 7 patients treated by piezoelectric (Piezotome; Satelec) crestal sinus lift with bone grafting (xenograft) and implant placement.
Read the detailed description
Patients have been asked asked to use 0.12% chlorhexidine digluconate rinse, and Povidone iodine solution will be used to perform extraoral antisepsis. After administration of local anesthesia at the implant site, a full thickness flap was elevated to expose the crest of alveolar ridge. A pilot drill will be used to start the osteotomy preparation, which should be ended 1mm short of sinus floor.
In group 1; (closed sinus lifting with Osteotome): The drills can be sequentially used to widen the osteotomy site to the same level (1 mm short of the sinus floor), an osteotome of diameter a little less than the planned implant body, will be inserted in the prepared osteotomy site and gently tapped to reach the same level, the osteotome will be tapped gently to fracture up the sinus floor.
In group 2; (closed sinus lifting with densah drills): Change the drill motor to reverse-densifying Mode (counterclockwise drill speed 800-1500 rpm with copious irrigation), Begin with the densah bur (2.5mm) until 1 mm short of the sinus floor, use the next wider Densah Bur (3.0mm) in the same mode and advance it into the previously created osteotomy with modulating pressure and a pumping motion. When feeling the haptic feedback of the drill reaching the dense sinus floor, modulate pressure with a gentle pumping motion to advance past the sinus floor in 1 mm increments, the next wider densah drills advance in the osteotomy.
In group 3: The initial osteotomy will be performed with a 2-mm twist drill to remove the cortical bone, then the intralift tips (Intralift; TKW1, TKW2, TKW3, TKW4, TKW5; Satelec). TKW1 to TKW4 tips have diameters of 1.35 mm, 2.1 mm, 2.35 mm, and 2.8 mm and will be used to gradually widen the access canal to the Schneider membrane, gentle pressure will be applied on the tips to deepen the pathway, and a sterile spray (80 mL/min) cooling the tips to avoid heat injury. The TKW5 tip will be then inserted into the access canal, and the ultrasonic activation for 5 seconds with internal irrigation of 40 mL/min and repeated at 50 mL/min and then 60 mL/min. The sinus membrane will be pushed upward by the hydraulic pressure, the floating of the sinus membrane will be evaluated, and then the TKW4 (Ø 2.8 mm) will be used again to widen the access canal to the sinus membrane before plugging the bone graft.
For all groups: Clinical check for membrane still intact, blocking the patient's nostrils and asking the patient to blow through his or her nose. Xenograft was added as the grafting material and pushed to the sinus through the osteotomy site until the desired height of sinus elevation will be gained, the implant fixture will be inserted. Smart peg will be placed on implant and Ostell will be used to record ISQ. Cover screw will be placed on implant and flab will be sutured. Sutures were removed after 10 days.
- Conditions
- Maxillary Sinus Augmentation
- Being tested
- osteotome crestal sinus lifting, osseodensification crestal sinus lifting, piezoelectric crestal sinus lifting
- Keywords
- deficient posterior maxilla, crestal sinus lift, dental implant, bone density, bone graft, maxillary sinus augmentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
osteotome crestal sinus liftingProcedure or surgery
Full thickness flap elevated to expose the crest of alveolar ridge. Pilot drill used to start the osteotomy preparation, which should be ended 1mm short of sinus floor. The drills can be sequentially used to widen the osteotomy site to the same level (1 mm short of the sinus floor), an osteotome of diameter a little less than the planned implant body, will be inserted in the prepared osteotomy site and gently tapped to reach the same level, the osteotome will be tapped gently to fracture up the sinus floor.Clinical check for membrane still intact, blocking the patient's nostrils and asking the patient to blow through his or her nose. Xenograft will be added as the grafting material and pushed to the sinus through the osteotomy site until the desired height of sinus elevation will be gained, the implant fixture will be inserted. Smart peg will be placed on implant and Ostell will be used to record ISQ.
osseodensification crestal sinus liftingProcedure or surgery
Full thickness flap elevated to expose the crest of alveolar ridge. Pilot drill used to start the osteotomy preparation, which should be ended 1mm short of sinus floor. Change the drill motor to reverse-densifying Mode (counterclockwise drill speed 800-1500 rpm with copious irrigation), Begin with the densah bur (2.5mm) until 1 mm short of the sinus floor, use the next wider Densah Bur (3.0mm) in the same mode and advance it into the previously created osteotomy with modulating pressure and a pumping motion. When feeling the haptic feedback of the drill reaching the dense sinus floor, modulate pressure with a gentle pumping motion to advance past the sinus floor in 1 mm increments, the next wider densah drills advance in the osteotomy.Clinical check for membrane still intact. Xenograft added and pushed to the sinus through the osteotomy site then the implant fixture will be inserted.
piezoelectric crestal sinus liftingProcedure or surgery
initial osteotomy will be performed with a 2-mm twist drill to remove the cortical bone, then the intralift tips (Intralift; TKW1, TKW2, TKW3,TKW4, TKW5; Satelec). TKW1 to TKW4 tips have diameters of 1.35 mm, 2.1 mm, 2.35 mm, and 2.8 mm and will be used to gradually widen the access canal to the Schneider membrane, gentle pressure will be applied on the tips to deepen the pathway, and a sterile spray (80 mL/min) cooling the tips to avoid heat injury. The TKW5 tip will be then inserted into the access canal, and the ultrasonic activation for 5 seconds with internal irrigation of 40 mL/min and repeated at 50 mL/min and then 60 mL/min. The sinus membrane will be pushed upward by the hydraulic pressure, the floating of the sinus membrane will be evaluated, and then the TKW4 (Ø 2.8 mm) will be used again to widen the access canal to the sinus membrane before plugging the bone graft.xenograft added. Implant fixture inserted and flap statured
| Study group | Role | What they receive |
|---|---|---|
| Osteotome crestal sinus lifting | Experimental | Full thickness flap elevated, then elevation of sinus floor by Osteotome, then adding the bone graft and implant placement. Measuring the ISQ value by Ostell device then flap sutured. After 6 months of implant placement exposure of implant for prosthetic phase and measuring secondary stability. Receives: Procedure: osteotome crestal sinus lifting |
| osseodensification crestal sinus lifting | Experimental | Full thickness flap elevated, then elevation of sinus floor by Densah burs, then adding the bone graft and implant placement. Measuring the ISQ value by Ostell device then flap sutured. After 6 months of implant placement exposure of implant for prosthetic phase and measuring secondary stability. Receives: Procedure: osseodensification crestal sinus lifting |
| peizoelectric crestal sinus lifting | Experimental | Full thickness flap elevated, then elevation of sinus floor through piezoelectric surgery via intralift kit, then adding the bone graft and implant placement. Measuring the ISQ value by Ostell device, followed by flap suturing. After 6 months of implant placement exposure of implant for prosthetic phase and measuring secondary stability. Receives: Procedure: piezoelectric crestal sinus lifting |
What is being measured
The primary outcome is the main question the study is designed to answer.
dental implant stability
evaluation of implant primary and secondary stability clinically using ostell device through measuring ISQ value
Measured: 6 months
maxillary sinus augmentation
evaluation of vertical bone gain using CBCT before and after six months of implant placement
Measured: 6 months
Secondary outcomes (2)
bone density
measuring bone density before and after 6 months of implant placement
Measured: 6 months
crestal bone loss
crestal bone loss after 6 months of implant placement
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 posted21 Feb 2023
- Study start15 Jan 2020
- Primary completion30 Mar 2022
- Study completion28 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Maxillary Sinus AugmentationStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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
- Model description
- The patients divided into 3 groups: Group 1:7patients treated by traditional closed sinus lift (osteotome) with bone grafting (xenograft) and implant placement. Group 2:7patients treated by densah drills(Versah, Jackson, MI, USA) sinus lift with bone grafting (xenograft) and implant placement. Group 3:7patients treated by piezoelectric (Piezotome; Satelec) crestal sinus lift with bone grafting (xenograft) and implant placement.
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Halim Hashem, Al-Azhar University
- Investigators
- Ahmed H. Hashem, Ass.Leturer, Principal investigator, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05735613
- Sponsor's protocol ID
- 410/293
- Status last verified
- Feb 2023
- First submitted
- 18 Mar 2022
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vercellotti T, De Paoli S, Nevins M. The piezoelectric bony window osteotomy and sinus membrane elevation: introduction of a new technique for simplification of the sinus augmentation procedure. Int J Periodontics Restorative Dent. 2001 Dec;21(6):561-7.
PubMed 11794567Huwais S, Meyer EG. A Novel Osseous Densification Approach in Implant Osteotomy Preparation to Increase Biomechanical Primary Stability, Bone Mineral Density, and Bone-to-Implant Contact. Int J Oral Maxillofac Implants. 2017 Jan/Feb;32(1):27-36. doi: 10.11607/jomi.4817. Epub 2016 Oct 14.
PubMed 27741329Summers RB. A new concept in maxillary implant surgery: the osteotome technique. Compendium. 1994 Feb;15(2):152, 154-6, 158 passim; quiz 162.
PubMed 8055503
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Different Techniques of Crestal Sinus Lifting to Place Dental Implant Into Prosterior Maxilla of Deficient Height: Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT05735613
- Acronym / sponsor ID
- 410/293
- Conditions
- Maxillary Sinus Augmentation
- Keywords
- deficient posterior maxilla, crestal sinus lift, dental implant, bone density, bone graft, maxillary sinus augmentation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 15 Jan 2020 (actual)
- Primary completion
- 30 Mar 2022 (actual)
- Study completion
- 28 Apr 2022 (actual)
- First posted
- 21 Feb 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.
Twenty one patients with deficient posterior maxilla and alveolar bone height ≤ 5mm were included.Those patients randomly divided into 3 equal groups:
- Group 1: 7 patients treated by osteotome closed sinus lift with bone grafting (xenograft) and implant placement.
- Group 2: 7 patients treated by densah burs(Versah, Jackson, MI, USA) sinus lift with bone grafting (xenograft) and implant placement.
- Group 3: 7 patients treated by piezoelectric (Piezotome; Satelec) crestal sinus lift with bone grafting (xenograft) and implant placement.
Detailed description
Patients have been asked asked to use 0.12% chlorhexidine digluconate rinse, and Povidone iodine solution will be used to perform extraoral antisepsis. After administration of local anesthesia at the implant site, a full thickness flap was elevated to expose the crest of alveolar ridge. A pilot drill will be used to start the osteotomy preparation, which should be ended 1mm short of sinus floor.
In group 1; (closed sinus lifting with Osteotome): The drills can be sequentially used to widen the osteotomy site to the same level (1 mm short of the sinus floor), an osteotome of diameter a little less than the planned implant body, will be inserted in the prepared osteotomy site and gently tapped to reach the same level, the osteotome will be tapped gently to fracture up the sinus floor.
In group 2; (closed sinus lifting with densah drills): Change the drill motor to reverse-densifying Mode (counterclockwise drill speed 800-1500 rpm with copious irrigation), Begin with the densah bur (2.5mm) until 1 mm short of the sinus floor, use the next wider Densah Bur (3.0mm) in the same mode and advance it into the previously created osteotomy with modulating pressure and a pumping motion. When feeling the haptic feedback of the drill reaching the dense sinus floor, modulate pressure with a gentle pumping motion to advance past the sinus floor in 1 mm increments, the next wider densah drills advance in the osteotomy.
In group 3: The initial osteotomy will be performed with a 2-mm twist drill to remove the cortical bone, then the intralift tips (Intralift; TKW1, TKW2, TKW3, TKW4, TKW5; Satelec). TKW1 to TKW4 tips have diameters of 1.35 mm, 2.1 mm, 2.35 mm, and 2.8 mm and will be used to gradually widen the access canal to the Schneider membrane, gentle pressure will be applied on the tips to deepen the pathway, and a sterile spray (80 mL/min) cooling the tips to avoid heat injury. The TKW5 tip will be then inserted into the access canal, and the ultrasonic activation for 5 seconds with internal irrigation of 40 mL/min and repeated at 50 mL/min and then 60 mL/min. The sinus membrane will be pushed upward by the hydraulic pressure, the floating of the sinus membrane will be evaluated, and then the TKW4 (Ø 2.8 mm) will be used again to widen the access canal to the sinus membrane before plugging the bone graft.
For all groups: Clinical check for membrane still intact, blocking the patient's nostrils and asking the patient to blow through his or her nose. Xenograft was added as the grafting material and pushed to the sinus through the osteotomy site until the desired height of sinus elevation will be gained, the implant fixture will be inserted. Smart peg will be placed on implant and Ostell will be used to record ISQ. Cover screw will be placed on implant and flab will be sutured. Sutures were removed after 10 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The patients divided into 3 groups: Group 1:7patients treated by traditional closed sinus lift (osteotome) with bone grafting (xenograft) and implant placement. Group 2:7patients treated by densah drills(Versah, Jackson, MI, USA) sinus lift with bone grafting (xenograft) and implant placement. Group 3:7patients treated by piezoelectric (Piezotome; Satelec) crestal sinus lift with bone grafting (xenograft) and implant placement.
| Arm | Type | Receives |
|---|---|---|
| Osteotome crestal sinus lifting | Experimental | Procedure: osteotome crestal sinus liftingFull thickness flap elevated, then elevation of sinus floor by Osteotome, then adding the bone graft and implant placement. Measuring the ISQ value by Ostell device then flap sutured. After 6 months of implant placement exposure of implant for prosthetic phase and measuring secondary stability. |
| osseodensification crestal sinus lifting | Experimental | Procedure: osseodensification crestal sinus liftingFull thickness flap elevated, then elevation of sinus floor by Densah burs, then adding the bone graft and implant placement. Measuring the ISQ value by Ostell device then flap sutured. After 6 months of implant placement exposure of implant for prosthetic phase and measuring secondary stability. |
| peizoelectric crestal sinus lifting | Experimental | Procedure: piezoelectric crestal sinus liftingFull thickness flap elevated, then elevation of sinus floor through piezoelectric surgery via intralift kit, then adding the bone graft and implant placement. Measuring the ISQ value by Ostell device, followed by flap suturing. After 6 months of implant placement exposure of implant for prosthetic phase and measuring secondary stability. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Young and adult patients of both sexes.
- Patients exhibit class C residual bone height according to ABC sinus augmentation classification.(18)
- The edentulous ridges are covered with mucoperiosteum free from signs of inflammation, ulceration or scar tissue.
- Remaining natural teeth have good periodontal tissue support.
- Occlusion showing sufficient inter-arch and intra-arch spaces for future prosthesis.
Key exclusion criteria (7 listed)
- Patients with systemic conditions that could influence the outcome of the therapy as: Pregnancy and Heavy smokers
- Patients with systemic disease that may affect bone quality.
- Uncooperative patients
- Patients with active periodontal disease.
- Patients with neglected oral hygiene.
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 |
|---|---|---|
| osteotome crestal sinus liftingFull thickness flap elevated to expose the crest of alveolar ridge. Pilot drill used to start the osteotomy preparation, which should be ended 1mm short of sinus floor. The drills can be sequentially used to widen the osteotomy site to the same level (1 mm short of the sinus floor), an osteotome of diameter a little less than the planned implant body, will be inserted in the prepared osteotomy site and gently tapped to reach the same level, the osteotome will be tapped gently to fracture up the sinus floor.Clinical check for membrane still intact, blocking the patient's nostrils and asking the patient to blow through his or her nose. Xenograft will be added as the grafting material and pushed to the sinus through the osteotomy site until the desired height of sinus elevation will be gained, the implant fixture will be inserted. Smart peg will be placed on implant and Ostell will be used to record ISQ. | Procedure or surgery | Osteotome crestal sinus lifting |
| osseodensification crestal sinus liftingFull thickness flap elevated to expose the crest of alveolar ridge. Pilot drill used to start the osteotomy preparation, which should be ended 1mm short of sinus floor. Change the drill motor to reverse-densifying Mode (counterclockwise drill speed 800-1500 rpm with copious irrigation), Begin with the densah bur (2.5mm) until 1 mm short of the sinus floor, use the next wider Densah Bur (3.0mm) in the same mode and advance it into the previously created osteotomy with modulating pressure and a pumping motion. When feeling the haptic feedback of the drill reaching the dense sinus floor, modulate pressure with a gentle pumping motion to advance past the sinus floor in 1 mm increments, the next wider densah drills advance in the osteotomy.Clinical check for membrane still intact. Xenograft added and pushed to the sinus through the osteotomy site then the implant fixture will be inserted. | Procedure or surgery | osseodensification crestal sinus lifting |
| piezoelectric crestal sinus liftinginitial osteotomy will be performed with a 2-mm twist drill to remove the cortical bone, then the intralift tips (Intralift; TKW1, TKW2, TKW3,TKW4, TKW5; Satelec). TKW1 to TKW4 tips have diameters of 1.35 mm, 2.1 mm, 2.35 mm, and 2.8 mm and will be used to gradually widen the access canal to the Schneider membrane, gentle pressure will be applied on the tips to deepen the pathway, and a sterile spray (80 mL/min) cooling the tips to avoid heat injury. The TKW5 tip will be then inserted into the access canal, and the ultrasonic activation for 5 seconds with internal irrigation of 40 mL/min and repeated at 50 mL/min and then 60 mL/min. The sinus membrane will be pushed upward by the hydraulic pressure, the floating of the sinus membrane will be evaluated, and then the TKW4 (Ø 2.8 mm) will be used again to widen the access canal to the sinus membrane before plugging the bone graft.xenograft added. Implant fixture inserted and flap statured | Procedure or surgery | peizoelectric crestal sinus lifting |
Primary outcome
dental implant stability
Time frame: 6 months
evaluation of implant primary and secondary stability clinically using ostell device through measuring ISQ value
maxillary sinus augmentation
Time frame: 6 months
evaluation of vertical bone gain using CBCT before and after six months of implant placement
2 secondary outcomes
bone density
Time frame: 6 months
crestal bone loss
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- Background: PubMed 11794567Vercellotti T, De Paoli S, Nevins M. The piezoelectric bony window osteotomy and sinus membrane elevation: introduction of a new technique for simplification of the sinus augmentation procedure. Int J Periodontics Restorative Dent. 2001 Dec;21(6):561-7.
- Background: PubMed 27741329Huwais S, Meyer EG. A Novel Osseous Densification Approach in Implant Osteotomy Preparation to Increase Biomechanical Primary Stability, Bone Mineral Density, and Bone-to-Implant Contact. Int J Oral Maxillofac Implants. 2017 Jan/Feb;32(1):27-36. doi: 10.11607/jomi.4817. Epub 2016 Oct 14.
- Results publication: PubMed 8055503Summers RB. A new concept in maxillary implant surgery: the osteotome technique. Compendium. 1994 Feb;15(2):152, 154-6, 158 passim; quiz 162.
- 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.
Ahmed H. Hashem, Ass.Leturer principal investigator
Al-Azhar 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 osteotome crestal sinus lifting, osseodensification crestal sinus lifting and piezoelectric crestal sinus lifting in people with Maxillary Sinus Augmentation, run by Al-Azhar 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 5 inclusion and 7 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: finished, as of the sponsor's last update on 21 Feb 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
dental implant stability (time frame: 6 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 NCT05735613, which also lists 3 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 21 Feb 2023.