Completely Edentulous MaxillaPhase 2/3NCT05559632
Peri-Implant Marginal Bone Loss And Implant Stability In Maxillary Implant Overdenture When Using Osseodensification Versus Conventional Drills: A Randomized Clinical Trial
A Phase 2/3 study testing osteotomy for implant placement in people with Completely Edentulous Maxilla and Implant Placement, run by Cairo University at 1 site in Egypt.
Trial summary
Is to compare between the conventional drills versus osseodensification drills for implant stability and peri-implant marginal bone loss in maxillary implant overdenture. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Completely Edentulous Maxilla, Implant Placement, Maxillary Implant Overdenture
- What is being tested?
- osteotomy for implant placement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- Nov 2022to Nov 2024
- Phase
- Phase 2/3
- 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 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with completely edentulous maxilla.
- Sufficient inter-arch space not less 13mm inter-arch space.
- sufficient bone height to allow usage of at least 10mm implant length.
- Normal maxilla-mandibular relationship.
- minimum radiographic bone width bucco-palatally in canine and premolar regions to place at least 3.5mm implant diameter.
- participants more than forty years old.
- Opposing fully or partially restored dentition.
Who cannot join
- 1- Skeletal mal-relation. 2- Unmotivated patients to maintain adequate oral hygiene to follow up. 3- Patients with neuromuscular and Psychiatric disorders. 4- Systematic disease affecting bone and periodontal health such as diabetic patients.
- 5- Insufficient inter-arch space less than 13mm. 6- Patients with physical reasons that could affect follow up. 7- patients administrating antibiotics 8- smoker patients 9- patients with any systemic or local condition that obstacles implant placement 10- patients with a history of radiotherapy in the head and neck region
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
faculty of dentistry- Cairo university
Cairo, 11511
About this study
Is to compare between the conventional drills versus osseodensification drills for implant stability and peri-implant marginal bone loss in maxillary implant overdenture.
Read the detailed description
Comprehensive clinical examination and understanding of patient's chief complaints and their expectations from the prosthesis.
- medical and dental history
- A complete denture will be constructed for each patient to aid in the scan technique, if the patient has an denture, it will be evaluated to be used.
- The complete denture will be constructed following conventional denture fabrication procedures.
- CBCT radiograph will be taken for bone height and width, and identify the vital structures before implant placement.
- A surgical guide will be used to aid in the implant placement, each patient will be scheduled for surgery to insert four root form implants. Each patient will receive four implants at canine and premolar regions from the same implant manufacturer.
Study group: The osseodensification drilling group (G1), bone preparation was performed using tapered multifluted burs (Densah Bur; Versah, MI, USA) at 800- 1200 rpm counterclockwise rotation under saline irrigation. Drilling to the desired depth using the tapered densah pilot drill with speed of 800-1200 rpm with copious irrigation without any lateral pressure with clock wise motion.
Control group: In the conventional drilling group (G2), drilling the other contralateral sites of bone using the conventional sequential drilling system according to the manufactural instruction.
- All patients received 2gm/day amoxicillin, clavulanate and 50 mg/8 hours non-steroidal anti-inflammatory analgesics for 5 days postoperatively. Postoperative instructions included a soft diet and appropriate oral hygiene measures with 0.2% chlorhexidine mouth rinse.
- After four months, the implants will be exposed and attachment (stud attachment) will be screwed to the implants. Then, overdenture pick-up is done. * Number of visits \& follow up period
- 5 visits for construction of denture
- 1 visit for CBCT
- 1 visit for implant insertion
- 1 visit for attachment placement and pick-up of overdenture
- Patients will be recalled at base line,4 and 7 weeks 4 and 12 months following implant insertion for outcomes assessment
- Being tested
- osteotomy for implant placement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
osteotomy for implant placementProcedure or surgery
preparing the bone for implant placement
| Study group | Role | What they receive |
|---|---|---|
| conventional drilling group | Active comparator | drilling the other contralateral sites of bone using the conventional sequential drilling system according to the manufactural instruction. Receives: Procedure: osteotomy for implant placement |
| osseodensification drilling group | Experimental | bone preparation was performed using tapered multifluted burs (Densah Bur; Versah, MI, USA) at 800- 1200 rpm counterclockwise rotation under saline irrigation. Drilling to the desired depth using the tapered densah pilot drill with speed of 800-1200 rpm with copious irrigation without any lateral pressure with clock wise motion. Receives: Procedure: osteotomy for implant placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peri-implant marginal bone loss
Radiographic follow up will be performed for marginal bone loss. Serial of standardized digital periapical radiographs using; long cone paralleling technique, XCP periapical film holder and an individually constructed radiographic acrylic template will be taken at the time of implant placement (base line) then at 4,12 months.
Measured: 1 year
Secondary outcomes (1)
Implant stability measurements
The Osstell will be used according to the manufacturer's instructions and held perpendicular to the provided implant smart peg. Osstell values (ISQ) are going to be obtained for the bucco-lingual, mesio-distal surfaces of each implant. Three measurements will be made for each surface and the mean will be obtained for statistical analysis.for each implant will be done at the time of surgery, at 4 weeks , 7weeks and 4 months
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2022
- Study startNov 2022 (estimated)
- Primary completionMar 2024 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Completely Edentulous MaxillaStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- prof. Nadia Ahmed Abbas, dr. Doaa Mahmoud abd elhameed elkady
- Responsible party
- Principal investigator, Marwa Essam El-Dein Mohamed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05559632
- Sponsor's protocol ID
- 13722
- Status last verified
- Sep 2022
- First submitted
- 26 Sep 2022
- Last updated
- 29 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peri-Implant Marginal Bone Loss And Implant Stability In Maxillary Implant Overdenture When Using Osseodensification Versus Conventional Drills: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05559632
- Acronym / sponsor ID
- 13722
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- prof. Nadia Ahmed Abbas, dr. Doaa Mahmoud abd elhameed elkady
- Study start
- Nov 2022 (estimated)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 29 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Is to compare between the conventional drills versus osseodensification drills for implant stability and peri-implant marginal bone loss in maxillary implant overdenture.
Detailed description
Comprehensive clinical examination and understanding of patient's chief complaints and their expectations from the prosthesis.
- medical and dental history
- A complete denture will be constructed for each patient to aid in the scan technique, if the patient has an denture, it will be evaluated to be used.
- The complete denture will be constructed following conventional denture fabrication procedures.
- CBCT radiograph will be taken for bone height and width, and identify the vital structures before implant placement.
- A surgical guide will be used to aid in the implant placement, each patient will be scheduled for surgery to insert four root form implants. Each patient will receive four implants at canine and premolar regions from the same implant manufacturer.
Study group: The osseodensification drilling group (G1), bone preparation was performed using tapered multifluted burs (Densah Bur; Versah, MI, USA) at 800- 1200 rpm counterclockwise rotation under saline irrigation. Drilling to the desired depth using the tapered densah pilot drill with speed of 800-1200 rpm with copious irrigation without any lateral pressure with clock wise motion.
Control group: In the conventional drilling group (G2), drilling the other contralateral sites of bone using the conventional sequential drilling system according to the manufactural instruction.
- All patients received 2gm/day amoxicillin, clavulanate and 50 mg/8 hours non-steroidal anti-inflammatory analgesics for 5 days postoperatively. Postoperative instructions included a soft diet and appropriate oral hygiene measures with 0.2% chlorhexidine mouth rinse.
- After four months, the implants will be exposed and attachment (stud attachment) will be screwed to the implants. Then, overdenture pick-up is done. * Number of visits \& follow up period
- 5 visits for construction of denture
- 1 visit for CBCT
- 1 visit for implant insertion
- 1 visit for attachment placement and pick-up of overdenture
- Patients will be recalled at base line,4 and 7 weeks 4 and 12 months following implant insertion for outcomes assessment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional drilling group | Active comparator | Procedure: osteotomy for implant placementdrilling the other contralateral sites of bone using the conventional sequential drilling system according to the manufactural instruction. |
| osseodensification drilling group | Experimental | Procedure: osteotomy for implant placementbone preparation was performed using tapered multifluted burs (Densah Bur; Versah, MI, USA) at 800- 1200 rpm counterclockwise rotation under saline irrigation. Drilling to the desired depth using the tapered densah pilot drill with speed of 800-1200 rpm with copious irrigation without any lateral pressure with clock wise motion. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with completely edentulous maxilla.
- Sufficient inter-arch space not less 13mm inter-arch space.
- sufficient bone height to allow usage of at least 10mm implant length.
- Normal maxilla-mandibular relationship.
- minimum radiographic bone width bucco-palatally in canine and premolar regions to place at least 3.5mm implant diameter.
Key exclusion criteria (2 listed)
- 1- Skeletal mal-relation. 2- Unmotivated patients to maintain adequate oral hygiene to follow up. 3- Patients with neuromuscular and Psychiatric disorders. 4- Systematic disease affecting bone and periodontal health such as diabetic patients.
- 5- Insufficient inter-arch space less than 13mm. 6- Patients with physical reasons that could affect follow up. 7- patients administrating antibiotics 8- smoker patients 9- patients with any systemic or local condition that obstacles implant placement 10- patients with a history of radiotherapy in the head and neck region
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 |
|---|---|---|
| osteotomy for implant placementpreparing the bone for implant placement | Procedure or surgery | conventional drilling group, osseodensification drilling group |
Primary outcome
Peri-implant marginal bone loss
Time frame: 1 year
Radiographic follow up will be performed for marginal bone loss. Serial of standardized digital periapical radiographs using; long cone paralleling technique, XCP periapical film holder and an individually constructed radiographic acrylic template will be taken at the time of implant placement (base line) then at 4,12 months.
1 secondary outcome
Implant stability measurements
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing osteotomy for implant placement in people with Completely Edentulous Maxilla and Implant Placement, 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 7 inclusion and 2 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 29 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 marwa essam mohamed (01158291633, marwa.essam@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peri-implant marginal bone loss (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Sep 2022.