Horizontal Ridge DeficiencyNCT06580626
Various Techniques of Horizontal Ridge Augmentation
A study testing decompression technique, guided bone regenaration using Ethoss and ridge splitting technqiue in people with Horizontal Ridge Deficiency, run by Mansoura University at 1 site in Egypt.
Trial summary
42 patients will be selected from the Outpatient Clinic of the Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Mansoura University for replacement of missed single tooth or multiple teeth in posterior mandible by dental implant in horizontally atrophic ridge. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Horizontal Ridge Deficiency
- What is being tested?
- decompression technique, guided bone regenaration using Ethoss and ridge splitting technqiue
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2023to 1 Aug 2024
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patient's cooperation, motivation and good oral hygiene.
- Patient medically free from systemic diseases that absolutely contraindicate implant surgery.
- Moderately atrophic posterior mandibular alveolar ridge width (more than 4 mm), with minimum 10 mm height.
- Free from history of bruxism / parafunctional habits.
Who cannot join
- Patients with local pathological disease such as cyst, tumor at the planned surgical site.
- Pregnant patients.
- Heavy smoker patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Decompression Technique Versus Ridge Splitting and Ethoss Bone Regeneration in Horizontal Ridge Augmentation With Simultaneous Implant Placement
42 patients will be selected from the Outpatient Clinic of the Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Mansoura University for replacement of missed single tooth or multiple teeth in posterior mandible by dental implant in horizontally atrophic ridge.
- Conditions
- Horizontal Ridge Deficiency
- Being tested
- decompression technique, guided bone regenaration using Ethoss, ridge splitting technqiue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
decompression techniqueProcedure or surgery
14 implants will be placed in patients of missing single tooth or multiple teeth in posterior mandible with subsequent horizontal ridge augmentation by decompression technique.
guided bone regenaration using EthossProcedure or surgery
14 implants will be placed in patients of missing single tooth or multiple teeth in posterior mandible with subsequent horizontal ridge augmentation by guided bone regeneration using β-TCP/CS synthetic bone substitute.
ridge splitting technqiueProcedure or surgery
14 implants will be placed in patients of missing single tooth or multiple teeth in posterior mandible with subsequent horizontal ridge augmentation by ridge splitting technique using piezosurgery.
| Study group | Role | What they receive |
|---|---|---|
| decompression group | Experimental | Not described Receives: Procedure: decompression technique |
| Ethoss group | Experimental | Not described Receives: Procedure: guided bone regenaration using Ethoss |
| ridge splitting group | Experimental | Not described Receives: Procedure: ridge splitting technqiue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alveolar ridge width.
Overall width of the ridge was evaluated preoperatively, after implant placement immediately, after 6, and 12 months postoperative
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 posted30 Aug 2024
- Study start1 Jul 2023
- Primary completion1 Aug 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Horizontal Ridge DeficiencyStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heba Elsheikh, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06580626
- Sponsor's protocol ID
- A0108024OS
- Status last verified
- Aug 2024
- First submitted
- 28 Aug 2024
- Last updated
- 30 Aug 2024
- 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 30 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decompression Technique Versus Ridge Splitting and Ethoss Bone Regeneration in Horizontal Ridge Augmentation With Simultaneous Implant Placement
- ClinicalTrials.gov ID
- NCT06580626
- Acronym / sponsor ID
- A0108024OS
- Conditions
- Horizontal Ridge Deficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 30 Aug 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.
42 patients will be selected from the Outpatient Clinic of the Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Mansoura University for replacement of missed single tooth or multiple teeth in posterior mandible by dental implant in horizontally atrophic ridge.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| decompression group | Experimental | Procedure: decompression technique |
| Ethoss group | Experimental | Procedure: guided bone regenaration using Ethoss |
| ridge splitting group | Experimental | Procedure: ridge splitting technqiue |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patient's cooperation, motivation and good oral hygiene.
- Patient medically free from systemic diseases that absolutely contraindicate implant surgery.
- Moderately atrophic posterior mandibular alveolar ridge width (more than 4 mm), with minimum 10 mm height.
- Free from history of bruxism / parafunctional habits.
Key exclusion criteria (3 listed)
- Patients with local pathological disease such as cyst, tumor at the planned surgical site.
- Pregnant patients.
- Heavy smoker patients.
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 |
|---|---|---|
| decompression technique14 implants will be placed in patients of missing single tooth or multiple teeth in posterior mandible with subsequent horizontal ridge augmentation by decompression technique. | Procedure or surgery | decompression group |
| guided bone regenaration using Ethoss14 implants will be placed in patients of missing single tooth or multiple teeth in posterior mandible with subsequent horizontal ridge augmentation by guided bone regeneration using β-TCP/CS synthetic bone substitute. | Procedure or surgery | Ethoss group |
| ridge splitting technqiue14 implants will be placed in patients of missing single tooth or multiple teeth in posterior mandible with subsequent horizontal ridge augmentation by ridge splitting technique using piezosurgery. | Procedure or surgery | ridge splitting group |
Primary outcome
Alveolar ridge width.
Time frame: 1 year
Overall width of the ridge was evaluated preoperatively, after implant placement immediately, after 6, and 12 months postoperative
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 30 Aug 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.
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 decompression technique, guided bone regenaration using Ethoss and ridge splitting technqiue in people with Horizontal Ridge Deficiency, run by Mansoura 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 30 Aug 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?
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?
Alveolar ridge width. (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 30 Aug 2024.