Horizontal Ridge DeficiencyNCT03153995
Alveolar Ridge Augmentation Following Self-Inflating Soft Tissue Expander
A study testing soft tissue expansion in people with Horizontal Ridge Deficiency, run by Ain Shams University at 1 site in Egypt.
Trial summary
The objective of this study will be to assess and compare between sub-periosteal self- inflating osmotic tissue expanders used as preparatory surgery before alveolar ridge augmentation and periosteal releasing incision using autogenous onlay block bone graft. The assessment and comparison will be based on: 1. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Horizontal Ridge Deficiency
- What is being tested?
- soft tissue expansion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2017to 1 Nov 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- All patients should have partially edentulous ridge (missing upper one or two neighboring anterior teeth or premolars) of the maxilla. The edentulous area should require horizontal bone augmentation procedures owing to lack of sufficient residual bone.
- All patients should not have any particular medical history (medically free) according to Burket health medical history questionnaire (Glick et al.2008).
- All patients should not have any known contraindication to oral surgery.
Who cannot join
- Smokers will be excluded from our study.
- Patients with poor oral hygiene or not willing to perform oral hygiene measures.
- Patients who showed residual infections in the edentulous area or apparent infection in a neighboring tooth.
- Patients with systemic diseases such as diabetes mellitus and hemorrhagic disorders, patients receiving intravenous bisphosphonate therapy or systemic corticosteroid treatment.
- Patients with occlusal discrepancies will be excluded.
- Vulnerable groups (as pregnant and lactating females, and decisionaly impaired individuals) will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of dentistry Ain Shams university
Cairo, Cairo Governorate, 11553
About this study
Official title: Alveolar Ridge Augmentation Following Self-Inflating Soft Tissue Expander: A Randomized Controlled Clinical and Histological Study
The objective of this study will be to assess and compare between sub-periosteal self- inflating osmotic tissue expanders used as preparatory surgery before alveolar ridge augmentation and periosteal releasing incision using autogenous onlay block bone graft.
The assessment and comparison will be based on:
- Change in edentulous alveolar ridge in bucco-lingual dimension after alveolar ridge augmentation.
- Quantity of the soft tissue obtained after soft tissue expansion.
Read the detailed description
- Sixteen patients will be selected from the outpatient clinic of the department of, Oral medicine Periodontology, and oral diagnosis, Faculty of Dentistry, Ain Shams University.
- Three surgeries will be carried out for group I patient; the first is placement of soft tissue expander, the second surgery is bone grafting and placement of collagen membrane for ridge augmentation while the third (re-entry surgery) is implant placement in a routine fashion. two surgeries will be carried out for group II patient; the first is surgery is bone grafting for ridge augmentation while the second (re-entry surgery) is implant placement in a routine fashion.
-Measurements and evaluation of edentulous ridge will be done by CBCT
- Conditions
- Horizontal Ridge Deficiency
- Being tested
- soft tissue expansion
- Keywords
- expander
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
soft tissue expansionProcedure or surgery
Also called osmed
Three surgeries will be carried out for group I patients:
- Soft tissue expansion (1st surgery); at baseline
- Alveolar ridge augmentation (2nd surgery); after five weeks
- Implant surgery (3rd surgery); after six months
| Study group | Role | What they receive |
|---|---|---|
| sub-periosteal soft tissue expansion | Experimental | Eight patients will receive osmotic hydrogel expanders prior to bone augmentation procedures. All expanders will be placed in sub-periosteal positions using the tunnel technique. Receives: Procedure: soft tissue expansion |
| periosteal releasing incision | Active comparator | periosteal releasing incision will be performed for Eight patients during ridge augmentation surgery . Receives: Procedure: soft tissue expansion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ridge dimensional alteration by CBCT
The ridge width will be compared between the two treatment groups by CBCT
Measured: baseline, 6 months after surgery, 3 months after implant surgery
Secondary outcomes (1)
Soft tissue volume gain
Soft tissue volume gain will be assessed by volumetric analysis
Measured: baseline, 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2017
- Study start1 Nov 2017
- Primary completion1 Mar 2020
- Study completion1 Nov 2020
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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Talaat Ali, Ain Shams University
- Investigators
- Ahmed Amr, lecturer, Study director, Ainshams UniversityNevine Kheir eldin, professor, Study director, Ainshams UniversityEhab Abd elhamid, professor, Study director, Ainshams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03153995
- Sponsor's protocol ID
- FDASU-REC per-16-3
- Status last verified
- Nov 2020
- First submitted
- 4 May 2017
- Last updated
- 1 Dec 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 1 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alveolar Ridge Augmentation Following Self-Inflating Soft Tissue Expander: A Randomized Controlled Clinical and Histological Study
- ClinicalTrials.gov ID
- NCT03153995
- Acronym / sponsor ID
- FDASU-REC per-16-3
- Conditions
- Horizontal Ridge Deficiency
- Keywords
- expander
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Nov 2020 (actual)
- First posted
- 15 May 2017 (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 objective of this study will be to assess and compare between sub-periosteal self- inflating osmotic tissue expanders used as preparatory surgery before alveolar ridge augmentation and periosteal releasing incision using autogenous onlay block bone graft.
The assessment and comparison will be based on:
- Change in edentulous alveolar ridge in bucco-lingual dimension after alveolar ridge augmentation.
- Quantity of the soft tissue obtained after soft tissue expansion.
Detailed description
- Sixteen patients will be selected from the outpatient clinic of the department of, Oral medicine Periodontology, and oral diagnosis, Faculty of Dentistry, Ain Shams University.
- Three surgeries will be carried out for group I patient; the first is placement of soft tissue expander, the second surgery is bone grafting and placement of collagen membrane for ridge augmentation while the third (re-entry surgery) is implant placement in a routine fashion. two surgeries will be carried out for group II patient; the first is surgery is bone grafting for ridge augmentation while the second (re-entry surgery) is implant placement in a routine fashion.
-Measurements and evaluation of edentulous ridge will be done by CBCT
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sub-periosteal soft tissue expansion | Experimental | Procedure: soft tissue expansionEight patients will receive osmotic hydrogel expanders prior to bone augmentation procedures. All expanders will be placed in sub-periosteal positions using the tunnel technique. |
| periosteal releasing incision | Active comparator | Procedure: soft tissue expansionperiosteal releasing incision will be performed for Eight patients during ridge augmentation surgery . |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- All patients should have partially edentulous ridge (missing upper one or two neighboring anterior teeth or premolars) of the maxilla. The edentulous area should require horizontal bone augmentation procedures owing to lack of sufficient residual bone.
- All patients should not have any particular medical history (medically free) according to Burket health medical history questionnaire (Glick et al.2008).
- All patients should not have any known contraindication to oral surgery.
Key exclusion criteria (6 listed)
- Smokers will be excluded from our study.
- Patients with poor oral hygiene or not willing to perform oral hygiene measures.
- Patients who showed residual infections in the edentulous area or apparent infection in a neighboring tooth.
- Patients with systemic diseases such as diabetes mellitus and hemorrhagic disorders, patients receiving intravenous bisphosphonate therapy or systemic corticosteroid treatment.
- Patients with occlusal discrepancies will be excluded.
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 |
|---|---|---|
| soft tissue expansionAlso: osmedThree surgeries will be carried out for group I patients: * Soft tissue expansion (1st surgery); at baseline * Alveolar ridge augmentation (2nd surgery); after five weeks * Implant surgery (3rd surgery); after six months | Procedure or surgery | periosteal releasing incision, sub-periosteal soft tissue expansion |
Primary outcome
Change in ridge dimensional alteration by CBCT
Time frame: baseline, 6 months after surgery, 3 months after implant surgery
The ridge width will be compared between the two treatment groups by CBCT
1 secondary outcome
Soft tissue volume gain
Time frame: baseline, 4 weeks
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 1 Dec 2020.
- Individual participant dataSharing planned: No
Related trials for Horizontal Ridge Deficiency
Not yet recruiting
Autogenous and Xenograft Bone Mix in Alveolar Ridge Reconstruction
Horizontal Alveolar Ridge Deficiency
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Comparison of Three Autogenous Bone and Xenograft Ratios for Horizontal Ridge Augmentation
Horizontal Alveolar Ridge Deficiency
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Comparison of Two Autogenous Bone and Xenograft Ratios for Horizontal Ridge Augmentation
Horizontal Alveolar Ridge Deficiency
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Shell Technique for Implant Site Development
Ridge Augmentation, Ridge Deficiency
Recruiting
Histological and Histomorphometric Assessment With Inflammatory Profile Analysis of Bone Tissue After Horizontal Ridge Augmentation Using Customized Porous Zirconia Shell
Alveolar Bone Loss, Alveolar Ridge Deficiency
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.
Ahmed Amr, lecturer study director
Ainshams University
Nevine Kheir eldin, professor study director
Ainshams University
Ehab Abd elhamid, professor study director
Ainshams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing soft tissue expansion in people with Horizontal Ridge Deficiency, run by Ain Shams 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 3 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: finished, as of the sponsor's last update on 1 Dec 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?
Change in ridge dimensional alteration by CBCT (time frame: baseline, 6 months after surgery, 3 months after implant surgery). 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 1 Dec 2020.