Atrophic Maxillary Ridge and Mandibular RidgeimplantNCT06274476
Prosthetic Rehabilitation of Thin Wiry Ridge by Ridge Splitting and Simultaneous Implants Placement
A study testing implant placement in people with Atrophic Maxillary Ridge and Mandibular Ridge, run by Cairo University at 1 site in Egypt.
Trial summary
evaluates the success of prosthetic rehabilitation of thin wiry ridge and implants placed simultaneously in splitted ridge both clinically and radiographically. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Atrophic Maxillary Ridge and Mandibular Ridge
- What is being tested?
- implant placement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteEgypt
- Study dates
- 9 Sep 2018to 1 Jan 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- ridge of 2 to 4 mm of initial alveolar crest width
- bone height of at least 8 mm from vitastructures
- good oral hygiene.
Who cannot join
- patients who smoke more than 10 cigarettes per day diabetes mellitus, osteoporosis, and periodontal disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Short-Term Evaluation of Prosthetic Rehabilitation of Thin Wiry Ridge by Ridge Splitting and Simultaneous Implants Placement: Non-randomized Control Trial
evaluates the success of prosthetic rehabilitation of thin wiry ridge and implants placed simultaneously in splitted ridge both clinically and radiographically.
Read the detailed description
twenty-one participants were enrolled of which 13 patients (8 females and 5 males) were suffering from maxillary ridge atrophy and 8 patients (5 females and 3 males) had mandibular ridge atrophy; a total of 42 implants were performed using the ridge expansion technique. The expansion was performed using the conventional disk technique, piezoelectric corticotomy, and self-threading expanders. Implants were placed and loaded with fixed partial denture after 4 months for the mandible and 6 months for the maxilla. Implant stability quotient (ISQ) was measured at T0 (implant placement) and TL (loading). Crestal bone levels were measured at different times: T0, TL, and T12 (12 months). Evaluation of prosthetic and surgical complications was carried out. Data were analyzed and compared using analysis of variance and paired t-tests at a significance level of 5%.
- Being tested
- implant placement
- Keywords
- implant, knife-edge ridge, ridge expansion, piezoelectric, implant-supported prosthesis, prosthetic complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
implant placementOther
Also called implant installation
ridge splitting piezo surgery and implant placement
| Study group | Role | What they receive |
|---|---|---|
| maxillary atrophic ridge | Experimental | received ridge splitting done by piezo surgery and implant placement in maxillary arch Receives: Other: implant placement |
| mandibular atrophic ridge | Active comparator | received ridge splitting done by saw technique using ridge expanders and implant placement in maxillary arch Receives: Other: implant placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
implant success
implant osseointgeration by radiographic evaluation .bone loss by mm, and bone density
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2024
- Study start9 Sep 2018
- Primary completion9 Dec 2019
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrophic Maxillary Ridge and Mandibular RidgeStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- maxillary and mandibular atrophic ridge
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sharaf Mohamed Yahia, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06274476
- Sponsor's protocol ID
- 2020/9/9
- Acronym
- implant
- Status last verified
- Feb 2024
- First submitted
- 15 Feb 2024
- Last updated
- 23 Feb 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 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-Term Evaluation of Prosthetic Rehabilitation of Thin Wiry Ridge by Ridge Splitting and Simultaneous Implants Placement: Non-randomized Control Trial
- ClinicalTrials.gov ID
- NCT06274476
- Acronym / sponsor ID
- implant / 2020/9/9
- Keywords
- implant, knife-edge ridge, ridge expansion, piezoelectric, implant-supported prosthesis, prosthetic complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 9 Sep 2018 (actual)
- Primary completion
- 9 Dec 2019 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 23 Feb 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.
evaluates the success of prosthetic rehabilitation of thin wiry ridge and implants placed simultaneously in splitted ridge both clinically and radiographically.
Detailed description
twenty-one participants were enrolled of which 13 patients (8 females and 5 males) were suffering from maxillary ridge atrophy and 8 patients (5 females and 3 males) had mandibular ridge atrophy; a total of 42 implants were performed using the ridge expansion technique. The expansion was performed using the conventional disk technique, piezoelectric corticotomy, and self-threading expanders. Implants were placed and loaded with fixed partial denture after 4 months for the mandible and 6 months for the maxilla. Implant stability quotient (ISQ) was measured at T0 (implant placement) and TL (loading). Crestal bone levels were measured at different times: T0, TL, and T12 (12 months). Evaluation of prosthetic and surgical complications was carried out. Data were analyzed and compared using analysis of variance and paired t-tests at a significance level of 5%.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- maxillary and mandibular atrophic ridge
| Arm | Type | Receives |
|---|---|---|
| maxillary atrophic ridge | Experimental | Other: implant placementreceived ridge splitting done by piezo surgery and implant placement in maxillary arch |
| mandibular atrophic ridge | Active comparator | Other: implant placementreceived ridge splitting done by saw technique using ridge expanders and implant placement in maxillary arch |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- ridge of 2 to 4 mm of initial alveolar crest width
- bone height of at least 8 mm from vitastructures
- good oral hygiene.
Key exclusion criteria (1 listed)
- patients who smoke more than 10 cigarettes per day diabetes mellitus, osteoporosis, and periodontal disease.
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 placementAlso: implant installationridge splitting piezo surgery and implant placement | Other | mandibular atrophic ridge, maxillary atrophic ridge |
Primary outcome
implant success
Time frame: 12 month
implant osseointgeration by radiographic evaluation .bone loss by mm, and bone density
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 23 Feb 2024.
- Individual participant dataSharing planned: No
Related trials for Atrophic Maxillary Ridge and Mandibular Ridge
Recruiting
Two Bovine Xenografts in Lateral Window Sinus Augmentation With or Without Bone Marrow Blood
Alveolar Bone Loss, Sinus Floor Augmentation
Not yet recruiting
Osseodensification Versus Alveolar Ridge Splitting
Maxillary Deficiency, Horizontal Alveolar Bone Defect
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 placement in people with Atrophic Maxillary Ridge and Mandibular Ridge, run by Cairo 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 1 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 23 Feb 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?
implant success (time frame: 12 month). 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 23 Feb 2024.