Bone GraftRCTNCT05403112
Simultaneous Implant Placement With Autogenous Bone Ring
A study testing Bone ring with open sinus lifting in people with Bone Graft, run by Omar Saleh Ahmed Bassed at 1 site in Egypt.
Trial summary
This study is aiming to evaluate bone gain and secondary stability in autogenous bone ring technique using trephine bur compared to control group of sticky bone. Read more about this study
- Who is it for?
- Ages 26 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Bone Graft
- What is being tested?
- Bone ring with open sinus lifting
- 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
- 1 Sep 2022to 1 Sep 2023
- 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 26 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with edentulous vertically deficient posterior maxillary ridge a 4-5 mm. height of alveolar bone.
- Both males as well as females without any active periodontal disease.
- All patients are in a good health with no systemic, immunologic or debilitating diseases that could affect normal bone healing.
- All selected patients are non-smokers and non-alcoholics.
- Patients are free from T.M.J troubles, abnormal oral habits such as bruxism.
- The edentulous ridges are covered with optimal thickness of mucoperiosteum with no signs of inflammation, ulceration or scar tissue.
- Remaining natural teeth have good periodontal tissue support and occlusion showed sufficient inter arch space for future prosthesis.
Who cannot join
- On the local level, patients with maxillary sinus diseases, former sinus surgery and unfavorable inter maxillary relationship will be excluded.
- General contraindications to implant surgery.
- Subjected to irradiation in the head and neck area less than 1 year before implantation.
- Untreated periodontitis.
- Poor oral hygiene and motivation.
- Uncontrolled diabetes.
Show all 18Show fewer
- Pregnant or nursing.
- Substance abuse.
- Psychiatric problems or unrealistic expectations.
- Severe bruxism or clenching.
- Immunosuppressed or immunocompromised.
- Treated or under treatment with intravenous amino-bisphosphonates.
- Lack of opposite occluding dentition/prosthesis in the area intended for implant placement.
- Active infection or severe inflammation in the area intended for implant placement.
- Need of bone augmentation procedures at implant placement.
- Unable to open mouth sufficiently to accommodate the surgical tooling.
- Patients participating in other studies, if the present protocol could not be properly followed.
- Referred only for implant placement or unable to attend a 5-year follow-up.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Cairo University
Cairo, Giza Governorate, 12613
Omar Bassed, Master, 00201093667522, Omarsaleh@dentistry.cu.edu.eg
Mohammed Omara, Phd, +20 01286004984, omara_mohammed@ymail.com
About this study
Official title: Simultaneous Implant Placement With Autogenous Bone Ring Transplant vs Autologous Sticky Bone Graft in Maxillary Sinus Lifting " Randomization Clinical Trial"
This study is aiming to evaluate bone gain and secondary stability in autogenous bone ring technique using trephine bur compared to control group of sticky bone.
Read the detailed description
The main prerequisite of achieving proper implant placement with ideal functional and proper restoration particularly in the posterior maxilla may compromise with violation to Schneiderian membrane especially in pneumatized maxillary Antrum when RBH < 4 mm, Conventional lateral sinus floor elevation (CLSFE) is one of the most common surgical techniques used for increasing the available bone volume to place implants and restore function and esthetics in severe atrophic maxilla.
The objective of this study was to evaluate sinus elevation with simultaneous implant placement using open technique and bone ring versus sticky bone clinically and radiographically in terms of secondary stability and bone gain around the implant
- Conditions
- Bone Graft
- Being tested
- Bone ring with open sinus lifting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone ring with open sinus liftingProcedure or surgery
Also called Sticky bone with open sinus lifting, simultaneous implant
All patients involved in this study will be divided in to two group each group will receive a different technique of sinus lifting use autogenous bone ring technique with study group and autogenous sticky bone with control group.
| Study group | Role | What they receive |
|---|---|---|
| Group I: autogenous bone rings | Active comparator | sinus lifting was augmented by bone rings were harvested from chin Receives: Procedure: Bone ring with open sinus lifting |
| GroupII : autogenous sticky bone | Active comparator | sinus lifting was augmented by autogenous sticky bone was harvested from chin and immediate implant placement Receives: Procedure: Bone ring with open sinus lifting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change bone gain
bone gain (increase bone volume) Measuring the crestal bone height by CT.
Measured: Immediate post-operative and 6 months post-operative CT scans will be done to evaluate the bone density, apical bone gain will be measured
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2022
- Study start1 Sep 2022 (estimated)
- Primary completion1 Aug 2023 (estimated)
- Study completion1 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bone GraftStudies of the same condition, open and under way.
- 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
- randomization clinical trial
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Omar Saleh Ahmed Bassed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Omar Saleh Ahmed Bassed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05403112
- Sponsor's protocol ID
- Simultaneous implant placement
- Acronym
- RCT
- Status last verified
- Jun 2022
- First submitted
- 29 May 2022
- Last updated
- 27 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Starch-Jensen T, Deluiz D, Vitenson J, Bruun NH, Tinoco EMB. Maxillary Sinus Floor Augmentation with Autogenous Bone Graft Compared with a Composite Grafting Material or Bone Substitute Alone: a Systematic Review and Meta-Analysis Assessing Volumetric Stability of the Grafting Material. J Oral Maxillofac Res. 2021 Mar 31;12(1):e1. doi: 10.5037/jomr.2021.12101. eCollection 2021 Jan-Mar.
PubMed 33959236Omara M, Abdelwahed N, Ahmed M, Hindy M. Simultaneous implant placement with ridge augmentation using an autogenous bone ring transplant. Int J Oral Maxillofac Surg. 2016 Apr;45(4):535-44. doi: 10.1016/j.ijom.2015.11.001. Epub 2015 Nov 28.
PubMed 26644216
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simultaneous Implant Placement With Autogenous Bone Ring Transplant vs Autologous Sticky Bone Graft in Maxillary Sinus Lifting " Randomization Clinical Trial"
- ClinicalTrials.gov ID
- NCT05403112
- Acronym / sponsor ID
- RCT / Simultaneous implant placement
- Conditions
- Bone Graft
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Omar Saleh Ahmed BassedUniversity, hospital or other
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- 1 Aug 2023 (estimated)
- Study completion
- 1 Sep 2023 (estimated)
- First posted
- 3 Jun 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.
This study is aiming to evaluate bone gain and secondary stability in autogenous bone ring technique using trephine bur compared to control group of sticky bone.
Detailed description
The main prerequisite of achieving proper implant placement with ideal functional and proper restoration particularly in the posterior maxilla may compromise with violation to Schneiderian membrane especially in pneumatized maxillary Antrum when RBH < 4 mm, Conventional lateral sinus floor elevation (CLSFE) is one of the most common surgical techniques used for increasing the available bone volume to place implants and restore function and esthetics in severe atrophic maxilla.
The objective of this study was to evaluate sinus elevation with simultaneous implant placement using open technique and bone ring versus sticky bone clinically and radiographically in terms of secondary stability and bone gain around the implant
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- randomization clinical trial
| Arm | Type | Receives |
|---|---|---|
| Group I: autogenous bone rings | Active comparator | Procedure: Bone ring with open sinus liftingsinus lifting was augmented by bone rings were harvested from chin |
| GroupII : autogenous sticky bone | Active comparator | Procedure: Bone ring with open sinus liftingsinus lifting was augmented by autogenous sticky bone was harvested from chin and immediate implant placement |
Who may qualify
- Ages
- 26 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Patients with edentulous vertically deficient posterior maxillary ridge a 4-5 mm. height of alveolar bone.
- Both males as well as females without any active periodontal disease.
- All patients are in a good health with no systemic, immunologic or debilitating diseases that could affect normal bone healing.
- All selected patients are non-smokers and non-alcoholics.
- Patients are free from T.M.J troubles, abnormal oral habits such as bruxism.
Key exclusion criteria (18 listed)
- On the local level, patients with maxillary sinus diseases, former sinus surgery and unfavorable inter maxillary relationship will be excluded.
- General contraindications to implant surgery.
- Subjected to irradiation in the head and neck area less than 1 year before implantation.
- Untreated periodontitis.
- Poor oral hygiene and motivation.
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 |
|---|---|---|
| Bone ring with open sinus liftingAlso: Sticky bone with open sinus lifting, simultaneous implantAll patients involved in this study will be divided in to two group each group will receive a different technique of sinus lifting use autogenous bone ring technique with study group and autogenous sticky bone with control group. | Procedure or surgery | Group I: autogenous bone rings, GroupII : autogenous sticky bone |
Primary outcome
Change bone gain
Time frame: Immediate post-operative and 6 months post-operative CT scans will be done to evaluate the bone density, apical bone gain will be measured
bone gain (increase bone volume) Measuring the crestal bone height by CT.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2022.
- Results publication: PubMed 33959236Starch-Jensen T, Deluiz D, Vitenson J, Bruun NH, Tinoco EMB. Maxillary Sinus Floor Augmentation with Autogenous Bone Graft Compared with a Composite Grafting Material or Bone Substitute Alone: a Systematic Review and Meta-Analysis Assessing Volumetric Stability of the Grafting Material. J Oral Maxillofac Res. 2021 Mar 31;12(1):e1. doi: 10.5037/jomr.2021.12101. eCollection 2021 Jan-Mar.
- Results publication: PubMed 26644216Omara M, Abdelwahed N, Ahmed M, Hindy M. Simultaneous implant placement with ridge augmentation using an autogenous bone ring transplant. Int J Oral Maxillofac Surg. 2016 Apr;45(4):535-44. doi: 10.1016/j.ijom.2015.11.001. Epub 2015 Nov 28.
- Egyptian dental journalLink provided by the sponsor.
- 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 Bone ring with open sinus lifting in people with Bone Graft, run by Omar Saleh Ahmed Bassed 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 18 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 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.
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 Omar Bassed, Master (+201093667522, Omarsaleh@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change bone gain (time frame: Immediate post-operative and 6 months post-operative CT scans will be done to evaluate the bone density, apical bone gain will be measured). 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 NCT05403112, which also lists 2 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 27 Jun 2022.