Atrophic MaxillaNCT05352620
Smart Box With OT Equator Attachment in Retaining Implant-assisted Overdenture for the Atrophic Maxilla.
A study testing Implant assisted maxillary overdenture in people with Atrophic Maxilla and Edentulous Jaw, run by Hams Hamed Abdelrahman at 1 site in Egypt.
Trial summary
The aim of the present study is to clinically and radiographically evaluate the effect of the use of recently developed Smart Box accompanied with OT Equator attachment in retaining of the inclined implant assisted overdenture for atrophic maxilla and to compare the vertical bone changes around axial implants with OT… Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Atrophic Maxilla, Edentulous Jaw
- What is being tested?
- Implant assisted maxillary overdenture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2018to 1 May 2019
- 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 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male patients with comparable age (30- 65 years).
- All patients should have retruded, posteriorly atrophic completely edentulous maxilla with sinus pneumatization leaving less than 7mm bone height posteriorly and a sufficient amount of bone in the inter bicuspids region.
- Opposing mandibular dentate arch including bilateral posterior teeth.
- All patients should have an adequate zone of keratinized mucosa.
- All patients should be free from any intra-oral or systemic diseases that would otherwise affect the osseointegration of dental implants.
- All patients should be well motivated, cooperative, and with adequate manual dexterity necessary to place and remove removable implant prosthesis to provide adequate oral hygiene around the endosseous implants.
Who cannot join
- Patients with flabby maxillary ridges.
- Patients who are unwilling to accept implant overdentures as a treatment modality.
- Patients with temporomandibular and neuromuscular disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Smart Box Accompanied With OT Equator Attachment in Retaining Immediately Loaded Inclined Implant Assisted Overdenture for Atrophic Maxilla
The aim of the present study is to clinically and radiographically evaluate the effect of the use of recently developed Smart Box accompanied with OT Equator attachment in retaining of the inclined implant assisted overdenture for atrophic maxilla and to compare the vertical bone changes around axial implants with OT Equator attachment and inclined implants with smart box attachment radiographically using CBCT
- Conditions
- Atrophic Maxilla, Edentulous Jaw
- Being tested
- Implant assisted maxillary overdenture
- Medical subject headings
- Atrophic Maxilla, Jaw, Edentulous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implant assisted maxillary overdentureOther
For each patient, an implant assisted maxillary overdenture will be fabricated using a minimally invasive flapless surgical technique with OT-Equator and Smart Box attachment
| Study group | Role | What they receive |
|---|---|---|
| Implant assisted maxillary overdenture | Experimental | Horseshoe Maxillary Complete overdenture construction (Stabilizing and connecting the Smart Box housing) Receives: Other: Implant assisted maxillary overdenture |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in peri-implant probing depth
The peri-implant sulcus depth will be measured using a graduated plastic periodontal probe.
Measured: Baseline, 3 months, 6 months, 9 months
Change in Clinical Attachment level
It is the distance from the junction implant/abutment to the most apically probable portion, in millimeters
Measured: Baseline, 3 months, 6 months, 9 months
Change in Implant Stability
The Osstell unit records a numeric value of 1-100 which is referred to as the implant stability quotient (ISQ)
Measured: at baseline and 9 months
Change in alveolar bone level
The level of alveolar bone around each abutment will be evaluated using CBCT.
Measured: at baseline and 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2022
- Study start1 Mar 2018
- Primary completion1 May 2019
- Study completion1 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrophic MaxillaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 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
- NCT05352620
- Sponsor's protocol ID
- Overdenture_2022
- Status last verified
- Apr 2022
- First submitted
- 23 Apr 2022
- Last updated
- 29 Apr 2022
- 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 29 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smart Box Accompanied With OT Equator Attachment in Retaining Immediately Loaded Inclined Implant Assisted Overdenture for Atrophic Maxilla
- ClinicalTrials.gov ID
- NCT05352620
- Acronym / sponsor ID
- Overdenture_2022
- Conditions
- Atrophic Maxilla, Edentulous Jaw
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Hams Hamed AbdelrahmanUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 1 May 2019 (actual)
- Study completion
- 1 May 2019 (actual)
- First posted
- 29 Apr 2022 (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 the present study is to clinically and radiographically evaluate the effect of the use of recently developed Smart Box accompanied with OT Equator attachment in retaining of the inclined implant assisted overdenture for atrophic maxilla and to compare the vertical bone changes around axial implants with OT Equator attachment and inclined implants with smart box attachment radiographically using CBCT
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Implant assisted maxillary overdenture | Experimental | Other: Implant assisted maxillary overdentureHorseshoe Maxillary Complete overdenture construction (Stabilizing and connecting the Smart Box housing) |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male patients with comparable age (30- 65 years).
- All patients should have retruded, posteriorly atrophic completely edentulous maxilla with sinus pneumatization leaving less than 7mm bone height posteriorly and a sufficient amount of bone in the inter bicuspids region.
- Opposing mandibular dentate arch including bilateral posterior teeth.
- All patients should have an adequate zone of keratinized mucosa.
- All patients should be free from any intra-oral or systemic diseases that would otherwise affect the osseointegration of dental implants.
Key exclusion criteria (3 listed)
- Patients with flabby maxillary ridges.
- Patients who are unwilling to accept implant overdentures as a treatment modality.
- Patients with temporomandibular and neuromuscular disorders.
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 |
|---|---|---|
| Implant assisted maxillary overdentureFor each patient, an implant assisted maxillary overdenture will be fabricated using a minimally invasive flapless surgical technique with OT-Equator and Smart Box attachment | Other | Implant assisted maxillary overdenture |
Primary outcome
change in peri-implant probing depth
Time frame: Baseline, 3 months, 6 months, 9 months
The peri-implant sulcus depth will be measured using a graduated plastic periodontal probe.
Change in Clinical Attachment level
Time frame: Baseline, 3 months, 6 months, 9 months
It is the distance from the junction implant/abutment to the most apically probable portion, in millimeters
Change in Implant Stability
Time frame: at baseline and 9 months
The Osstell unit records a numeric value of 1-100 which is referred to as the implant stability quotient (ISQ)
Change in alveolar bone level
Time frame: at baseline and 9 months
The level of alveolar bone around each abutment will be evaluated using 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 29 Apr 2022.
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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 Implant assisted maxillary overdenture in people with Atrophic Maxilla and Edentulous Jaw, 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 6 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 29 Apr 2022. 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 peri-implant probing depth (time frame: Baseline, 3 months, 6 months, 9 months). The study lists 4 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 29 Apr 2022.