Alveolar Ridge EnlargementNCT04376320
Comparison of Two Pre-prosthetic Surgical Techniques for Augmentation of Mandibular Vertical Ridge Defects
A study testing customised ceramic sheets (Group 1) and modified sausage technique (Group 2) in people with Alveolar Ridge Enlargement, run by Lydia Nabil at 1 site in Egypt.
Trial summary
The aim of this study is to compare two pre-prosthetic surgical techniques for augmentation of vertical mandibular ridge defects in preparation for implant placement, the first using customized ceramic membranes and the second using tenting titanium screws in conjunction with particulate bone graft and collagen… Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Alveolar Ridge Enlargement
- What is being tested?
- customised ceramic sheets (Group 1) and modified sausage technique (Group 2)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2020to 4 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 40 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- patients of both genders
- with age range from 40 to 60 years,
- having about 7 mm of vertical bone height in the posterior mandible above the inferior alveolar canal and
- requiring prosthetic rehabilitation with dental implants.
Who cannot join
- heavy smokers,
- patients undergoing radiotherapy or chemotherapy,
- those having infection or local lesions in the area of surgery, and
- patients with bone diseases which may compromise the results
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to compare two pre-prosthetic surgical techniques for augmentation of vertical mandibular ridge defects in preparation for implant placement, the first using customized ceramic membranes and the second using tenting titanium screws in conjunction with particulate bone graft and collagen membrane (modified sausage technique).
Read the detailed description
Background: Expansion of the periosteum and soft tissue matrix by tenting has been described as a method of Guided Bone Regeneration (GBR) for reconstruction of atrophic alveolar ridges.
Materials and Methods: The current study is a prospective controlled clinical trial, conducted on 14 patients, having about 7 mm of vertical bone height in the posterior mandible above the inferior alveolar canal. They are divided into 2 equal groups, each consisting of 7 patients. The first group receives customized ceramic membranes with a vertical height 5 mm above the crest of the ridge to tent out the soft tissue matrix, while in the second group, tenting of the soft tissue is done by fixation of two tenting screws, particulate bone graft is packed then covered by collagen membrane that is fixed by bone tacks (modified sausage technique).
- Conditions
- Alveolar Ridge Enlargement
- Being tested
- customised ceramic sheets (Group 1), modified sausage technique (Group 2)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
customised ceramic sheets (Group 1)Device
guided bone regeneration
modified sausage technique (Group 2)Combination product
guided bone regeneration
| Study group | Role | What they receive |
|---|---|---|
| Group 1(ceramic membrane) | Active comparator | using customized ceramic membranes for augmentation of vertical mandibular ridge defects in preparation for implant placement Receives: Device: customised ceramic sheets (Group 1) |
| Group 2 (modified sausage technique) | Active comparator | using tenting titanium screws in conjunction with particulate bone graft and collagen membrane (modified sausage technique) for augmentation of vertical mandibular ridge defects in preparation for implant placement Receives: Combination Product: modified sausage technique (Group 2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean percentage of change of alveolar bone height
change of alveolar bone height after surgery
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2020
- Study start1 Apr 2020
- Primary completion30 Sep 2020
- Study completion4 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Ridge EnlargementStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lydia Nabil
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lydia Nabil, University of Alexandria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04376320
- Sponsor's protocol ID
- UAlexandriaDentSurg
- Status last verified
- Nov 2020
- First submitted
- 29 Apr 2020
- Last updated
- 4 Nov 2020
- 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 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Pre-prosthetic Surgical Techniques for Augmentation of Mandibular Vertical Ridge Defects
- ClinicalTrials.gov ID
- NCT04376320
- Acronym / sponsor ID
- UAlexandriaDentSurg
- Conditions
- Alveolar Ridge Enlargement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Lydia NabilUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 4 Oct 2020 (actual)
- First posted
- 6 May 2020 (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 aim of this study is to compare two pre-prosthetic surgical techniques for augmentation of vertical mandibular ridge defects in preparation for implant placement, the first using customized ceramic membranes and the second using tenting titanium screws in conjunction with particulate bone graft and collagen membrane (modified sausage technique).
Detailed description
Background: Expansion of the periosteum and soft tissue matrix by tenting has been described as a method of Guided Bone Regeneration (GBR) for reconstruction of atrophic alveolar ridges.
Materials and Methods: The current study is a prospective controlled clinical trial, conducted on 14 patients, having about 7 mm of vertical bone height in the posterior mandible above the inferior alveolar canal. They are divided into 2 equal groups, each consisting of 7 patients. The first group receives customized ceramic membranes with a vertical height 5 mm above the crest of the ridge to tent out the soft tissue matrix, while in the second group, tenting of the soft tissue is done by fixation of two tenting screws, particulate bone graft is packed then covered by collagen membrane that is fixed by bone tacks (modified sausage technique).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1(ceramic membrane) | Active comparator | Device: customised ceramic sheets (Group 1)using customized ceramic membranes for augmentation of vertical mandibular ridge defects in preparation for implant placement |
| Group 2 (modified sausage technique) | Active comparator | Combination Product: modified sausage technique (Group 2)using tenting titanium screws in conjunction with particulate bone graft and collagen membrane (modified sausage technique) for augmentation of vertical mandibular ridge defects in preparation for implant placement |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- patients of both genders
- with age range from 40 to 60 years,
- having about 7 mm of vertical bone height in the posterior mandible above the inferior alveolar canal and
- requiring prosthetic rehabilitation with dental implants.
Key exclusion criteria (4 listed)
- heavy smokers,
- patients undergoing radiotherapy or chemotherapy,
- those having infection or local lesions in the area of surgery, and
- patients with bone diseases which may compromise the results
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 |
|---|---|---|
| customised ceramic sheets (Group 1)guided bone regeneration | Device | Group 1(ceramic membrane) |
| modified sausage technique (Group 2)guided bone regeneration | Combination product | Group 2 (modified sausage technique) |
Primary outcome
mean percentage of change of alveolar bone height
Time frame: 6 months
change of alveolar bone height after surgery
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 4 Nov 2020.
- 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 customised ceramic sheets (Group 1) and modified sausage technique (Group 2) in people with Alveolar Ridge Enlargement, run by Lydia Nabil 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 4 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 4 Nov 2020. 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?
mean percentage of change of alveolar bone height (time frame: 6 months). 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 4 Nov 2020.