Maxillary Ridge AugmentationNCT04720495
One-stage Versus Two-stage Inverted U-shaped Ridge Splitting
A study testing One stage ridge splitting with simultaneous implant placement and Two-stage ridge splitting with implant placement in people with Maxillary Ridge Augmentation, run by Hams Hamed Abdelrahman at 1 site in Egypt.
Trial summary
Fourteen patients having anterior maxillary undercut defect were selected to match a list of inclusion and exclusion criteria. The participants were randomly allocated using a computer system into two groups: Group A undergo inverted U-shaped maxillary ridge splitting using piezotomes with simultaneous implant… Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- Maxillary Ridge Augmentation
- What is being tested?
- One stage ridge splitting with simultaneous implant placement and Two-stage ridge splitting with implant placement
- 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 Oct 2019to 30 Sep 2020
- 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 20 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult patients (20-45) years of age with no sex predilection
- At least one tooth missing in the anterior maxilla
- The presence of a labial undercut >2 mm in thickness which is not able to house an implant
- The presence of adequate bone width near the alveolar bone crest
- The absence of a vertical bone defect.
Who cannot join
- History of any systemic disease that would contraindicate surgery example uncontrolled diabetes.
- Pregnancy or lactation.
- Long-term amino-bisphosphonate therapy.
- Smoking more than 10 cigarettes per day.
- Alcohol or drug abuse.
- Uncontrolled periodontal disease.
Show all 9Show fewer
- Active infection.
- Inadequate inter-incisal space.
- Bruxism or clenching.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University
Alexandria
About this study
Official title: One-stage Versus Two-stage Inverted U-shaped Ridge Splitting With Simultaneous Implant Placement for Treatment of Anterior Maxillary Alveolar Ridge Undercut (a Comparative Randomized Clinical Trial)
Fourteen patients having anterior maxillary undercut defect were selected to match a list of inclusion and exclusion criteria.
The participants were randomly allocated using a computer system into two groups:
Group A undergo inverted U-shaped maxillary ridge splitting using piezotomes with simultaneous implant placement in the same surgery.
Group B undergo inverted U-shaped maxillary ridge splitting as a first stage and after four weeks, ridge expansion and implant placement will be performed with only envelop flap.
Assessment included measurements of bone gain at the undercut defect and bone density labial to implants in each group from the cone-beam computed tomography
- Conditions
- Maxillary Ridge Augmentation
- Being tested
- One stage ridge splitting with simultaneous implant placement, Two-stage ridge splitting with implant placement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One stage ridge splitting with simultaneous implant placementProcedure or surgery
A full mucoperiosteal flap was raised using the sharp periosteal elevator to expose the bone crestally and buccally.
An inverted U-shaped bone cut, down to the cancellous bone, was done in the undercut area with a piezoelectric device.
The horizontal bone cut was made apical to the most concave point in the undercut area with a distance of 3 mm.
The two vertical bone cuts were placed at least 1 mm away from the adjacent roots and extended beyond the undercut area.
The released bone end was minimally elevated using a periosteotome through a greenstick fracture.
All implants were installed with the implant shoulders flush to the bone level using a low-speed drilling procedure.
Two-stage ridge splitting with implant placementProcedure or surgery
The first surgery is the same as one stage ridge splitting Four weeks later, after revascularization between the bone block and the mucoperiosteum, the second surgery will be performed.
A crestal incision was done and the envelope flap slightly elevated to preserve the blood supply.
The implants will be placed in the same manner as one stage ridge splitting
| Study group | Role | What they receive |
|---|---|---|
| One stage ridge splitting | Active comparator | Not described Receives: Procedure: One stage ridge splitting with simultaneous implant placement |
| Two-stage ridge splitting | Experimental | Not described Receives: Procedure: Two-stage ridge splitting with implant placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in bone density buccal to the implant
Bone density was evaluated by CBCT
Measured: baseline and 4 months
Change in bone width gain at the undercut area
Bone width gain was evaluated by CBCT
Measured: baseline and 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start1 Oct 2019
- Primary completion30 Sep 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maxillary Ridge AugmentationStudies 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
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hams Hamed Abdelrahman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hams Hamed Abdelrahman, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04720495
- Sponsor's protocol ID
- Ridge_splitting
- Status last verified
- Jan 2021
- First submitted
- 19 Jan 2021
- Last updated
- 22 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One-stage Versus Two-stage Inverted U-shaped Ridge Splitting With Simultaneous Implant Placement for Treatment of Anterior Maxillary Alveolar Ridge Undercut (a Comparative Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT04720495
- Acronym / sponsor ID
- Ridge_splitting
- Conditions
- Maxillary Ridge Augmentation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Hams Hamed AbdelrahmanUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 22 Jan 2021 (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.
Fourteen patients having anterior maxillary undercut defect were selected to match a list of inclusion and exclusion criteria.
The participants were randomly allocated using a computer system into two groups:
Group A undergo inverted U-shaped maxillary ridge splitting using piezotomes with simultaneous implant placement in the same surgery.
Group B undergo inverted U-shaped maxillary ridge splitting as a first stage and after four weeks, ridge expansion and implant placement will be performed with only envelop flap.
Assessment included measurements of bone gain at the undercut defect and bone density labial to implants in each group from the cone-beam computed tomography
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| One stage ridge splitting | Active comparator | Procedure: One stage ridge splitting with simultaneous implant placement |
| Two-stage ridge splitting | Experimental | Procedure: Two-stage ridge splitting with implant placement |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Adult patients (20-45) years of age with no sex predilection
- At least one tooth missing in the anterior maxilla
- The presence of a labial undercut >2 mm in thickness which is not able to house an implant
- The presence of adequate bone width near the alveolar bone crest
- The absence of a vertical bone defect.
Key exclusion criteria (9 listed)
- History of any systemic disease that would contraindicate surgery example uncontrolled diabetes.
- Pregnancy or lactation.
- Long-term amino-bisphosphonate therapy.
- Smoking more than 10 cigarettes per day.
- Alcohol or drug abuse.
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 |
|---|---|---|
| One stage ridge splitting with simultaneous implant placementA full mucoperiosteal flap was raised using the sharp periosteal elevator to expose the bone crestally and buccally. An inverted U-shaped bone cut, down to the cancellous bone, was done in the undercut area with a piezoelectric device. The horizontal bone cut was made apical to the most concave point in the undercut area with a distance of 3 mm. The two vertical bone cuts were placed at least 1 mm away from the adjacent roots and extended beyond the undercut area. The released bone end was minimally elevated using a periosteotome through a greenstick fracture. All implants were installed with the implant shoulders flush to the bone level using a low-speed drilling procedure. | Procedure or surgery | One stage ridge splitting |
| Two-stage ridge splitting with implant placementThe first surgery is the same as one stage ridge splitting Four weeks later, after revascularization between the bone block and the mucoperiosteum, the second surgery will be performed. A crestal incision was done and the envelope flap slightly elevated to preserve the blood supply. The implants will be placed in the same manner as one stage ridge splitting | Procedure or surgery | Two-stage ridge splitting |
Primary outcome
Change in bone density buccal to the implant
Time frame: baseline and 4 months
Bone density was evaluated by CBCT
Change in bone width gain at the undercut area
Time frame: baseline and 4 months
Bone width gain was evaluated by CBCT
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 22 Jan 2021.
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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 One stage ridge splitting with simultaneous implant placement and Two-stage ridge splitting with implant placement in people with Maxillary Ridge Augmentation, run by Hams Hamed Abdelrahman 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 9 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 22 Jan 2021. 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?
Change in bone density buccal to the implant (time frame: baseline and 4 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?
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 22 Jan 2021.