Implant ComplicationNCT06477874
Assessment of Implants Placed in Consolidated Graft With Different Bone Drills.
A study testing Dental implants placement in people with Implant Complication and Bone Graft; Mechanical Complications, run by Beni-Suef University at 1 site in Egypt.
Trial summary
The anterior iliac crest is a popular source of bone harvest. However, when fused to the intramembranous jaw bones, it yields low-density bones that qualitatively and quantitatively endanger the fixture's stability. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Implant Complication, Bone Graft; Mechanical Complications
- What is being tested?
- Dental implants placement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteEgypt
- Study dates
- 9 Jun 2024to 1 Apr 2025
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients of both sexes with an age range of 18-55 years.
- Patients subjected to a successful iliac crest mandibular bone graft after segmental mandibular resection.
- A minimal ridge height of ten millimeters and a ridge width of seven millimeters.
- Healthy soft tissue coverage, with a reasonable interaction space.
Who cannot join
- Clinical or radiographic signs of graft infection, rejection, or massive resorption.
- The previous exposure to radiotherapy or chemotherapy.
- Any systemic disease that would affect bone healing or implant osseointegration.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Department of Oral and Maxillofacial Surgery, Faculty of Oral and Dental Medicine, Modern University for Technology & Information.
Cairo
About this study
Official title: ASSESSMENT OF DENTAL IMPLANTS PLACED IN MANDIBULAR CONSOLIDATED ILIAC-CREST BONE GRAFTS USING DENSAH BURS VERSUS THE STANDARD DRILLS (A Randomized Controlled Trial)
The anterior iliac crest is a popular source of bone harvest. However, when fused to the intramembranous jaw bones, it yields low-density bones that qualitatively and quantitatively endanger the fixture's stability.
In 1994, Summers first documented using the bone-condensing approach to improve the primary stability of dental implants.
This study aims to determine whether osseodensifying the consolidated mandibular bone grafts will improve implant stability and marginal bone loss
- Being tested
- Dental implants placement
- Keywords
- Bone graft, Iliac crest, Implant stability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental implants placementProcedure or surgery
implants placed in consolidated bone grafts
| Study group | Role | What they receive |
|---|---|---|
| Test group | Active comparator | The dental implants placed after bone osseodensification using densah burs Receives: Procedure: Dental implants placement |
| Control group | Active comparator | The dental implants placed after conventional bone drilling with the standard drills Receives: Procedure: Dental implants placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic bone loss
Calibration of the amplitude of vertical bone loss
Measured: 6 months osseointegration period
Secondary outcomes (1)
Implant stability
Calibration of primary and secondary implant stability quotient
Measured: 6 months osseointegration period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2024
- Study start9 Jun 2024
- Primary completion1 Apr 2025 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Implant ComplicationStudies of the same condition, open and under way.
- More trials run by Beni-Suef 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Gibaly, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06477874
- Sponsor's protocol ID
- 14
- Status last verified
- Jun 2024
- First submitted
- 21 Jun 2024
- Last updated
- 27 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ASSESSMENT OF DENTAL IMPLANTS PLACED IN MANDIBULAR CONSOLIDATED ILIAC-CREST BONE GRAFTS USING DENSAH BURS VERSUS THE STANDARD DRILLS (A Randomized Controlled Trial)
- ClinicalTrials.gov ID
- NCT06477874
- Acronym / sponsor ID
- 14
- Keywords
- Bone graft, Iliac crest, Implant stability
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 9 Jun 2024 (actual)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 27 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The anterior iliac crest is a popular source of bone harvest. However, when fused to the intramembranous jaw bones, it yields low-density bones that qualitatively and quantitatively endanger the fixture's stability.
In 1994, Summers first documented using the bone-condensing approach to improve the primary stability of dental implants.
This study aims to determine whether osseodensifying the consolidated mandibular bone grafts will improve implant stability and marginal bone loss
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group | Active comparator | Procedure: Dental implants placementThe dental implants placed after bone osseodensification using densah burs |
| Control group | Active comparator | Procedure: Dental implants placementThe dental implants placed after conventional bone drilling with the standard drills |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients of both sexes with an age range of 18-55 years.
- Patients subjected to a successful iliac crest mandibular bone graft after segmental mandibular resection.
- A minimal ridge height of ten millimeters and a ridge width of seven millimeters.
- Healthy soft tissue coverage, with a reasonable interaction space.
Key exclusion criteria (3 listed)
- Clinical or radiographic signs of graft infection, rejection, or massive resorption.
- The previous exposure to radiotherapy or chemotherapy.
- Any systemic disease that would affect bone healing or implant osseointegration.
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 |
|---|---|---|
| Dental implants placementimplants placed in consolidated bone grafts | Procedure or surgery | Control group, Test group |
Primary outcome
Radiographic bone loss
Time frame: 6 months osseointegration period
Calibration of the amplitude of vertical bone loss
1 secondary outcome
Implant stability
Time frame: 6 months osseointegration period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dental implants placement in people with Implant Complication and Bone Graft; Mechanical Complications, run by Beni-Suef 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 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maged Seleet, PHD (01000367625, magedseleet@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic bone loss (time frame: 6 months osseointegration period). 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 27 Jun 2024.