Edentulous Alveolar Ridge In MandibleNCT06723678
Evaluation of Bone Changes Around Implants in Patients Treated With All on Four
A study testing Two distally inclined 45-degree angle posterior implants and Two distally inclined 30-degree angle posterior implants in people with Edentulous Alveolar Ridge In Mandible and Complete Edentulism, run by Al-Azhar University at 1 site in Egypt.
Trial summary
The Goal of the clinical trail is to evaluate the Bone height changes around two axially placed anterior implants and two distally inclined 30-degree angle posterior implants in comparison to two axially placed anterior implants and two distally inclined 45-degree angle posterior implants using cone beam CT (CBCT). Read more about this study
- Who is it for?
- Ages 50 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Edentulous Alveolar Ridge In Mandible, Complete Edentulism, All on Four Technique
- What is being tested?
- Two distally inclined 45-degree angle posterior implants and Two distally inclined 30-degree angle posterior implants
- 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
- 26 Nov 2024to 1 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All patients' ages must range from 50-65 years old.
- All patients' ridges should be covered with firm mucosa free from any signs of inflammation or ulceration and exhibit adequate height and width of the residual alveolar ridge.
- Patients should be free from any metabolic or bone disorders that contraindicate implant installation.
- All patients must have sufficient inter arch space
Who cannot join
- Patients with oral or systemic diseases.
- Patients with xerostomia or excessive salivation.
- Patients with parafunctional habits (bruxism or clenching).
- Heavy smoker or alcoholic patients.
- Patients with history of temporo-mandibular dysfunction.
- Patients with brain disorders or psychiatric disorders
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Al-Azhar University Girls Branch
Cairo, Nasr City, 4450001
Noha T Kamel, lecturer, +0201112295457, yunie0959@gmail.com
Rehab A Soliman, Lecturer, +2010023235360, rehab.abdallah@miuegypt.edu.eg
About this study
Official title: Radiographic Evaluation of Crestal Bone Changes Around Implants in Patients Treated With Delayed Loaded All on Four (Randomized Clinical Trail)
The Goal of the clinical trail is to evaluate the Bone height changes around two axially placed anterior implants and two distally inclined 30-degree angle posterior implants in comparison to two axially placed anterior implants and two distally inclined 45-degree angle posterior implants using cone beam CT (CBCT).
Patients will visit the clinic after the surgery and after the framework and denture insertion for check ups and during the follow up periods ( at denture insertion, 6 months and 12 months)
Read the detailed description
All patients will receive upper complete dentures and mandibular All on-4 screw-retained prosthesis. The upper complete denture will be mucosa supported and the lower will be All on-4 screw-retained prosthesis. Patients will be divided into two equal groups; Group I will receive two axially placed anterior implants and two distally inclined 30-degree angle posterior implants, while Group II will receive two axially placed anterior implants and two distally inclined 45-degree angle posterior implants.
Both groups will be functionally loaded after three months of insertion. Bone height changes around axial and distally inclined implants will be evaluated using cone beam CT (CBCT), All records will be taken at time of denture insertion, 6 and 12 months later.
- Conditions
- Edentulous Alveolar Ridge In Mandible, Complete Edentulism, All on Four Technique, Dental Implant, Edentulous Jaws, Edentulous Mouth
- Being tested
- Two distally inclined 45-degree angle posterior implants, Two distally inclined 30-degree angle posterior implants
- Keywords
- Completely edentulous patients, Dental Implants, All on four technique, Fixed Detachable Prosthesis, screw retained prosthesis
- Medical subject headings
- Jaw, Edentulous, Mouth, Edentulous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Two distally inclined 45-degree angle posterior implantsProcedure or surgery
During the surgery, two axially placed anterior implants and two distally inclined 45-degree angle posterior implants will be placed, after healing period, All on-4 screw-retained prosthesis will be delivered to the patients.
Two distally inclined 30-degree angle posterior implantsProcedure or surgery
During the surgery, two axially placed anterior implants and two distally inclined 30-degree angle posterior implants will be placed, after healing period, All on-4 screw-retained prosthesis will be delivered to the patients
| Study group | Role | What they receive |
|---|---|---|
| Two distally inclined 45-degree angle posterior implants. | Experimental | During the surgery, two axially placed anterior implants and two distally inclined 45-degree angle posterior implants. Receives: Procedure: Two distally inclined 45-degree angle posterior implants |
| Two distally inclined 30-degree angle posterior implants. | Active comparator | During the surgery, two axially placed anterior implants and two distally inclined 30-degree angle posterior implants. Receives: Procedure: Two distally inclined 30-degree angle posterior implants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone Height Changes
Bone height changes around axially placed anterior implants and distally inclined posterior implants will be evaluated using cone beam CT (CBCT)
Measured: All records will be taken at time of denture insertion, 6 and 12 months later.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start26 Nov 2024
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Edentulous Alveolar Ridge In MandibleStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noha Taha Kamel Taha Alloush, Misr International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06723678
- Sponsor's protocol ID
- P-PD-24-28
- Status last verified
- Dec 2024
- First submitted
- 5 Dec 2024
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Protocol and Clinical Study Report
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiographic Evaluation of Crestal Bone Changes Around Implants in Patients Treated With Delayed Loaded All on Four (Randomized Clinical Trail)
- ClinicalTrials.gov ID
- NCT06723678
- Acronym / sponsor ID
- P-PD-24-28
- Conditions
- Edentulous Alveolar Ridge In Mandible, Complete Edentulism, All on Four Technique, Dental Implant, Edentulous Jaws, Edentulous Mouth
- Keywords
- Completely edentulous patients, Dental Implants, All on four technique, Fixed Detachable Prosthesis, screw retained prosthesis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 26 Nov 2024 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 9 Dec 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.
The Goal of the clinical trail is to evaluate the Bone height changes around two axially placed anterior implants and two distally inclined 30-degree angle posterior implants in comparison to two axially placed anterior implants and two distally inclined 45-degree angle posterior implants using cone beam CT (CBCT).
Patients will visit the clinic after the surgery and after the framework and denture insertion for check ups and during the follow up periods ( at denture insertion, 6 months and 12 months)
Detailed description
All patients will receive upper complete dentures and mandibular All on-4 screw-retained prosthesis. The upper complete denture will be mucosa supported and the lower will be All on-4 screw-retained prosthesis. Patients will be divided into two equal groups; Group I will receive two axially placed anterior implants and two distally inclined 30-degree angle posterior implants, while Group II will receive two axially placed anterior implants and two distally inclined 45-degree angle posterior implants.
Both groups will be functionally loaded after three months of insertion. Bone height changes around axial and distally inclined implants will be evaluated using cone beam CT (CBCT), All records will be taken at time of denture insertion, 6 and 12 months later.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Two distally inclined 45-degree angle posterior implants. | Experimental | Procedure: Two distally inclined 45-degree angle posterior implantsDuring the surgery, two axially placed anterior implants and two distally inclined 45-degree angle posterior implants. |
| Two distally inclined 30-degree angle posterior implants. | Active comparator | Procedure: Two distally inclined 30-degree angle posterior implantsDuring the surgery, two axially placed anterior implants and two distally inclined 30-degree angle posterior implants. |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- All patients' ages must range from 50-65 years old.
- All patients' ridges should be covered with firm mucosa free from any signs of inflammation or ulceration and exhibit adequate height and width of the residual alveolar ridge.
- Patients should be free from any metabolic or bone disorders that contraindicate implant installation.
- All patients must have sufficient inter arch space
Key exclusion criteria (6 listed)
- Patients with oral or systemic diseases.
- Patients with xerostomia or excessive salivation.
- Patients with parafunctional habits (bruxism or clenching).
- Heavy smoker or alcoholic patients.
- Patients with history of temporo-mandibular dysfunction.
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 |
|---|---|---|
| Two distally inclined 45-degree angle posterior implantsDuring the surgery, two axially placed anterior implants and two distally inclined 45-degree angle posterior implants will be placed, after healing period, All on-4 screw-retained prosthesis will be delivered to the patients. | Procedure or surgery | Two distally inclined 45-degree angle posterior implants. |
| Two distally inclined 30-degree angle posterior implantsDuring the surgery, two axially placed anterior implants and two distally inclined 30-degree angle posterior implants will be placed, after healing period, All on-4 screw-retained prosthesis will be delivered to the patients | Procedure or surgery | Two distally inclined 30-degree angle posterior implants. |
Primary outcome
Bone Height Changes
Time frame: All records will be taken at time of denture insertion, 6 and 12 months later.
Bone height changes around axially placed anterior implants and distally inclined posterior implants will be evaluated using cone beam CT (CBCT)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
- Individual participant dataSharing planned: Yes. Study Protocol and Clinical Study Report
Related trials for Edentulous Alveolar Ridge In Mandible
Recruiting
Two Bovine Xenografts in Lateral Window Sinus Augmentation With or Without Bone Marrow Blood
Alveolar Bone Loss, Sinus Floor Augmentation
Recruiting
Crestal Bone Loss Around Narrow Diameter Implants Versus Standard Diameter Implants With Bone Augmentation in Horizontally Deficient Posterior Mandibular Sites.
Horizontal Atrophy of Edentulous Alveolar Ridge
Active, not recruiting
Compare the Difference in Occlusal Force Distribution and Denture Retention Using 2 Different Denture Base Materials in Implant Retained Overdenture
Edentulous Alveolar Ridge In Mandible, Complete Edentulism
Recruiting
Clinical Effects of Keratinized Mucosa Augmentation Around Dental Implant With Free Gingival Graft in Different Surgical Timing at Mandibular Posterior Sites
Edentulous Alveolar Ridge In Mandible
Active, not recruiting
Using Two Different Attachments in Mandibular Implant Overdenture Cases in Order to Retention and Patient Satisfaction
Edentulous Alveolar Ridge, Complete Edentulism
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Two distally inclined 45-degree angle posterior implants and Two distally inclined 30-degree angle posterior implants in people with Edentulous Alveolar Ridge In Mandible and Complete Edentulism, run by Al-Azhar 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 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: looking for participants now, as of the sponsor's last update on 12 Dec 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Noha T Kamel, Lecturer (+201112295457, yunie0959@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone Height Changes (time frame: All records will be taken at time of denture insertion, 6 and 12 months later.). 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 12 Dec 2024.