Horizontal Ridge DeficiencyNCT03635658
Assessment of GBR in Augmentation of Horizontally Atrophic Maxillary Ridge Using Collagen Membrane Versus Using Titanium Mesh
A study testing titanium mesh and collagen membrane (Sausage technique) in people with Horizontal Ridge Deficiency, run by Cairo University.
Trial summary
this study is aiming to Assess postoperative complications and bone quality and quantity in augmentation of horizontally atrophic maxillary ridge using a 1:1 mixture of autograft and xenograft particulate bone covered with collagen membrane with the new Sausage technique™ versus using the same mixture covered with… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Horizontal Ridge Deficiency
- What is being tested?
- titanium mesh and collagen membrane (Sausage technique)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2018to 1 Oct 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with horizontal atrophied maxillary ridge (thin ridge) less than 4mm.
- All ages and both sexes were included in this study.
- Patients should be free from any systemic disease that may affect normal healing of bone, and predictable outcome.
- Patients with physical and psychological tolerance
Who cannot join
- Patients with high risk systemic diseases like uncontrolled diabetes mellitus. As uncontrolled diabetes mellitus has a negative impact on normal bone healing. 8
- Heavy smokers.4
- Alcohol or drug abuse
- Gingival bleeding or full mouth plaque index ≥ 25%.4
- Patients with physical and psychological intolerance. As psychological stress will affect the immune system and patient's fitness including healing capacity. 9
- Unavailability for regular follow-ups
About this study
Official title: Assessment of Guided Bone Regeneration in Augmentation of Horizontally Atrophic Maxillary Ridge Using Collagen Membrane Versus Using Titanium Mesh: a Randomized Controlled Clinical Trial
this study is aiming to Assess postoperative complications and bone quality and quantity in augmentation of horizontally atrophic maxillary ridge using a 1:1 mixture of autograft and xenograft particulate bone covered with collagen membrane with the new Sausage technique™ versus using the same mixture covered with titanium mesh.
Read the detailed description
patients with atrophic maxillary ridge < 4 mm will be selected in this study for augmentation for future implant placement. The full thickness flap will be elevated including one extra tooth on each side of the edentulous area or if completely edentulous 5 mm on each side.. the bone bed will be prepared by cleaning any debris and Multiple decortication holes will be performed with a 2.0 mm round bur. the harvested bone from the chin is then mixed with the xenograft with ratio 1:1 and then put on the recipient site and will be covered with a collagen membrane with the Sausage technique (intervention group) and the other group the graft will be covered with titanium mesh (control group).
flap is repositioned and sutured. followup for 6 months and then CBCT is done. Reopening after 6 months, core biopsy is taken by a 2 mm thickness trephine from the healed augmented bone at the site of implant placement and will be sent for histomorphometric analysis and the bone thickness (buccolingual ) dimension is measured using a caliper and from the CBCT (cone beam CT) the bone width gain will be calculates and recorded.
postoperative complications( infection, wound dehiscence or membrane exposure) will be monitored and recorded.
- Conditions
- Horizontal Ridge Deficiency
- Being tested
- titanium mesh, collagen membrane (Sausage technique)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
titanium meshProcedure or surgery
the non resorbable titanium mesh is used to fix the 1:1 mixture of autograft and xenograft particulate bone on the severely atrophies maxillary ridge.
collagen membrane (Sausage technique)Procedure or surgery
the resorbable collagen membrane is used to fix the 1:1 mixture of autograft and xenograft particulate bone on the severely atrophies maxillary ridge.
| Study group | Role | What they receive |
|---|---|---|
| titanium mesh | Active comparator | using non resorbable titanium mesh to fix and cover the onlay bone graft mixture to the atrophic maxillary ridge. Receives: Procedure: titanium mesh |
| collagen membrane(Sausage technique) | Experimental | using resorbable collagen membrane with the sausage technique to fix the onlay bone graft mixture to the resorbed atrophic maxillary ridge Receives: Procedure: collagen membrane (Sausage technique) |
What is being measured
The primary outcome is the main question the study is designed to answer.
membrane exposure
clinical postoperative complications as flap dehiscence and membrane exposure into the oral cavity, its a binary outcome (yes/No) examined and recorded by the investigator.
Measured: within 3 weeks
infection
suppuration collection related to the membrane and flap, its a binary outcome (yes/No) examined and recorded by the investigator.
Measured: 10 days
inflammation
redness and tenderness of the flap, its a binary outcome (yes/No) examined and recorded by the investigator.
Measured: 10 days
Secondary outcomes (2)
bone width gain
the amount of bone gained( in millimeter) after augmentation compared to the initial ridge thickness measured clinically using a caliper 2 mm below the crest of the ridge, and radiographically using the Planmeca Promax 3D CBCT unit which will be viewed on planmeca romexis software to calculate the measures needed in millimeter by the outcome assessor.
Measured: at 6 months
bone quality
histomorphometric analysis of the bone biopsy taken from the augmented bone to show the quality of the formed bone and the percentage of every type of tissue formed in the specimen taken( unit is area percentage %)
Measured: at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2018
- Study start1 Oct 2018 (estimated)
- Primary completion1 Mar 2019 (estimated)
- Study completion1 Oct 2020 (estimated)
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.
- More trials run by Cairo 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
- Model description
- the participants are divided into two groups one control and the other is the intervention
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Randa khaled Ismail, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03635658
- Sponsor's protocol ID
- CEBD-CU-2018-08-12
- Status last verified
- Aug 2018
- First submitted
- 13 Aug 2018
- Last updated
- 17 Aug 2018
- 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 17 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Guided Bone Regeneration in Augmentation of Horizontally Atrophic Maxillary Ridge Using Collagen Membrane Versus Using Titanium Mesh: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03635658
- Acronym / sponsor ID
- CEBD-CU-2018-08-12
- Conditions
- Horizontal Ridge Deficiency
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Oct 2018 (estimated)
- Primary completion
- 1 Mar 2019 (estimated)
- Study completion
- 1 Oct 2020 (estimated)
- First posted
- 17 Aug 2018 (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 Assess postoperative complications and bone quality and quantity in augmentation of horizontally atrophic maxillary ridge using a 1:1 mixture of autograft and xenograft particulate bone covered with collagen membrane with the new Sausage technique™ versus using the same mixture covered with titanium mesh.
Detailed description
patients with atrophic maxillary ridge < 4 mm will be selected in this study for augmentation for future implant placement. The full thickness flap will be elevated including one extra tooth on each side of the edentulous area or if completely edentulous 5 mm on each side.. the bone bed will be prepared by cleaning any debris and Multiple decortication holes will be performed with a 2.0 mm round bur. the harvested bone from the chin is then mixed with the xenograft with ratio 1:1 and then put on the recipient site and will be covered with a collagen membrane with the Sausage technique (intervention group) and the other group the graft will be covered with titanium mesh (control group).
flap is repositioned and sutured. followup for 6 months and then CBCT is done. Reopening after 6 months, core biopsy is taken by a 2 mm thickness trephine from the healed augmented bone at the site of implant placement and will be sent for histomorphometric analysis and the bone thickness (buccolingual ) dimension is measured using a caliper and from the CBCT (cone beam CT) the bone width gain will be calculates and recorded.
postoperative complications( infection, wound dehiscence or membrane exposure) will be monitored and recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- the participants are divided into two groups one control and the other is the intervention
| Arm | Type | Receives |
|---|---|---|
| titanium mesh | Active comparator | Procedure: titanium meshusing non resorbable titanium mesh to fix and cover the onlay bone graft mixture to the atrophic maxillary ridge. |
| collagen membrane(Sausage technique) | Experimental | Procedure: collagen membrane (Sausage technique)using resorbable collagen membrane with the sausage technique to fix the onlay bone graft mixture to the resorbed atrophic maxillary ridge |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with horizontal atrophied maxillary ridge (thin ridge) less than 4mm.
- All ages and both sexes were included in this study.
- Patients should be free from any systemic disease that may affect normal healing of bone, and predictable outcome.
- Patients with physical and psychological tolerance
Key exclusion criteria (6 listed)
- Patients with high risk systemic diseases like uncontrolled diabetes mellitus. As uncontrolled diabetes mellitus has a negative impact on normal bone healing. 8
- Heavy smokers.4
- Alcohol or drug abuse
- Gingival bleeding or full mouth plaque index ≥ 25%.4
- Patients with physical and psychological intolerance. As psychological stress will affect the immune system and patient's fitness including healing capacity. 9
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 |
|---|---|---|
| titanium meshthe non resorbable titanium mesh is used to fix the 1:1 mixture of autograft and xenograft particulate bone on the severely atrophies maxillary ridge. | Procedure or surgery | titanium mesh |
| collagen membrane (Sausage technique)the resorbable collagen membrane is used to fix the 1:1 mixture of autograft and xenograft particulate bone on the severely atrophies maxillary ridge. | Procedure or surgery | collagen membrane(Sausage technique) |
Primary outcome
membrane exposure
Time frame: within 3 weeks
clinical postoperative complications as flap dehiscence and membrane exposure into the oral cavity, its a binary outcome (yes/No) examined and recorded by the investigator.
infection
Time frame: 10 days
suppuration collection related to the membrane and flap, its a binary outcome (yes/No) examined and recorded by the investigator.
inflammation
Time frame: 10 days
redness and tenderness of the flap, its a binary outcome (yes/No) examined and recorded by the investigator.
2 secondary outcomes
bone width gain
Time frame: at 6 months
bone quality
Time frame: at 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2018.
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Comparison of Two Autogenous Bone and Xenograft Ratios for Horizontal Ridge Augmentation
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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.
Questions about this trial
What is this clinical trial studying?
A study testing titanium mesh and collagen membrane (Sausage technique) in people with Horizontal Ridge Deficiency, run by Cairo University.
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 6 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 17 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
membrane exposure (time frame: within 3 weeks). 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 17 Aug 2018.