Crestal Bone LossNCT06095843
"Bony Changes Around Dental Implant in Free Fibular Graft Versus Non-Vascularized Iliac Crest Graft"
A study testing placement of dental implants in people with Crestal Bone Loss and Survival Rate, run by Ain Shams University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to evaluate the bony changes around dental implants in non-vascularized iliac crest grafts and free vascularized fibular flap in mandibular reconstruction. The main question it aims to answer are: evaluate the bony changes around dental implants and it's survival rate in both groups Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Crestal Bone Loss, Survival Rate
- What is being tested?
- placement of dental implants
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2019to 30 Oct 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients following traumatic injuries
- gunshot injuries
- tumor ablative surgeries
- osteomylitis and osteonecrosis affecting the mandible
Who cannot join
- cardiovascular or pulmonary disease
- vascular or bone disorder
- previous fractures or surgeries related to the donor site
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "Bony Changes Around Dental Implant Placed in Free Vascularized Fibular Graft Versus Non-Vascularized Iliac Crest Graft in Mandibular Reconstruction"
The goal of this clinical trial is to evaluate the bony changes around dental implants in non-vascularized iliac crest grafts and free vascularized fibular flap in mandibular reconstruction.
The main question it aims to answer are:
- evaluate the bony changes around dental implants and it's survival rate in both groups
Read the detailed description
The current prospective study was conducted on 10 patients that were selected and admitted for early or delayed mandibular reconstructive surgery from the outpatient who were referred to the department of Oral and Maxillofacial Surgery Faculty of Dentisry, Ain Shams University in the period from January 2018 till June 2022.
The patients in this study were divided into two groups. First group endured non-vascularized iliac crest grafting with delayed implant insertion while the second group endured vascularized fibular flap with delayed implant insertion. Implant placement was done six months after performing reconstructive surgery.At the second stage surgery, all succeeded implants were loaded with fixed implant supported prothesis. Follow- up was done 1 week, 2 weeks, 4 weeks, 8 weeks and 12 weeks postoperatively.
Crestal bone stability was analyzed using CBCT radiographs along with the percentages of of the survived implants and ISQ values were measured using an ostell device.
- Conditions
- Crestal Bone Loss, Survival Rate
- Being tested
- placement of dental implants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placement of dental implantsProcedure or surgery
placement of dental implants in mandibular reconstruction.
| Study group | Role | What they receive |
|---|---|---|
| implants in free vascularized fibular flap | Active comparator | placement of dental implants in free fibular flaps after mandibular reconstruction Receives: Procedure: placement of dental implants |
| implants in non-vascularized iliac crest grafts | Active comparator | placement of dental implants in non-vascularized iliac crest grafts after mandibular reconstruction Receives: Procedure: placement of dental implants |
What is being measured
The primary outcome is the main question the study is designed to answer.
bony changes around dental implants
measuring crestal bone loss (mm)
Measured: 1 year
survival rate of dental implants
measuring survival rate of dental implants (%)
Measured: 1 year
stability of dental implants
measuring primary and secondary stability (ISK)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start1 Jan 2019
- Primary completion30 Oct 2022
- Study completion30 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crestal Bone LossStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maged Mohamed Mostafa, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06095843
- Sponsor's protocol ID
- 9D
- Status last verified
- Oct 2023
- First submitted
- 8 Nov 2022
- Last updated
- 24 Oct 2023
- Results posted
- No
- Data monitoring committee
- 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 24 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Bony Changes Around Dental Implant Placed in Free Vascularized Fibular Graft Versus Non-Vascularized Iliac Crest Graft in Mandibular Reconstruction"
- ClinicalTrials.gov ID
- NCT06095843
- Acronym / sponsor ID
- 9D
- Conditions
- Crestal Bone Loss, Survival Rate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 Oct 2022 (actual)
- Study completion
- 30 Oct 2022 (actual)
- First posted
- 23 Oct 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.
The goal of this clinical trial is to evaluate the bony changes around dental implants in non-vascularized iliac crest grafts and free vascularized fibular flap in mandibular reconstruction.
The main question it aims to answer are:
- evaluate the bony changes around dental implants and it's survival rate in both groups
Detailed description
The current prospective study was conducted on 10 patients that were selected and admitted for early or delayed mandibular reconstructive surgery from the outpatient who were referred to the department of Oral and Maxillofacial Surgery Faculty of Dentisry, Ain Shams University in the period from January 2018 till June 2022.
The patients in this study were divided into two groups. First group endured non-vascularized iliac crest grafting with delayed implant insertion while the second group endured vascularized fibular flap with delayed implant insertion. Implant placement was done six months after performing reconstructive surgery.At the second stage surgery, all succeeded implants were loaded with fixed implant supported prothesis. Follow- up was done 1 week, 2 weeks, 4 weeks, 8 weeks and 12 weeks postoperatively.
Crestal bone stability was analyzed using CBCT radiographs along with the percentages of of the survived implants and ISQ values were measured using an ostell device.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| implants in free vascularized fibular flap | Active comparator | Procedure: placement of dental implantsplacement of dental implants in free fibular flaps after mandibular reconstruction |
| implants in non-vascularized iliac crest grafts | Active comparator | Procedure: placement of dental implantsplacement of dental implants in non-vascularized iliac crest grafts after mandibular reconstruction |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients following traumatic injuries
- gunshot injuries
- tumor ablative surgeries
- osteomylitis and osteonecrosis affecting the mandible
Key exclusion criteria (3 listed)
- cardiovascular or pulmonary disease
- vascular or bone disorder
- previous fractures or surgeries related to the donor site
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 |
|---|---|---|
| placement of dental implantsplacement of dental implants in mandibular reconstruction. | Procedure or surgery | implants in free vascularized fibular flap, implants in non-vascularized iliac crest grafts |
Primary outcome
bony changes around dental implants
Time frame: 1 year
measuring crestal bone loss (mm)
survival rate of dental implants
Time frame: 1 year
measuring survival rate of dental implants (%)
stability of dental implants
Time frame: 1 year
measuring primary and secondary stability (ISK)
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 24 Oct 2023.
- Individual participant dataSharing planned: No
Related trials for Crestal Bone Loss
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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.
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 placement of dental implants in people with Crestal Bone Loss and Survival Rate, run by Ain Shams 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: finished, as of the sponsor's last update on 24 Oct 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?
bony changes around dental implants (time frame: 1 year). The study lists 3 primary outcomes in all. 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 24 Oct 2023; AzTrials last refreshed its copy on 7 Nov 2026.