Dental Implant Bone LossImplants typesNCT07588789
The Aim of the Study Will be Clinically and Radio Graphically Comparison of Two Implant Designs Used to Treat Atrophied Mandible . Implant Design Comparison Will Done for Implant Stability,Peri-implant Soft Tissue Health Changes and Bone Changes .Patients Will be Divided Randomly Into Two Group
A study testing Basal Dental implant and Compressive Dental implant in people with Dental Implant Bone Loss and Peri-Implant Health, run by Mansoura University at 1 site in Egypt.
Trial summary
The aim of the present study will be clinical and radio graphical comparison of four basal and compressive implant designs will be installed in the interforamina area of atrophied edentulous mandible and immediately loaded by bar retained mandibular overdenture . Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Dental Implant Bone Loss, Peri-Implant Health
- What is being tested?
- Basal Dental implant and Compressive Dental implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2026to 2 May 2027
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -
- mandibular and maxillary alveolar ridges are completely edentulous (2) There is not sufficient bone in the mandibular posterior molar area to place implants and there is a thin ridge anteriorly (3) skeletal class I maxilla-mandibular relationship (4) Devoid o f any systemic disorders related to bone resorptio
Who cannot join
- present of systematic disease Chem therapy Bone diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Basal Versus Compressive Implant Designs Immediately Loaded With Bar Retained Complete Overdenture for Atrophied Edentulous Mandibular Ridge: Clinical and Radiographic Study of peri_implant Tissue Health
The aim of the present study will be clinical and radio graphical comparison of four basal and compressive implant designs will be installed in the interforamina area of atrophied edentulous mandible and immediately loaded by bar retained mandibular overdenture .
Implant design comparison will be done clinically and radiographically after six month and one year of implant loading
Read the detailed description
Patients will be divided randomly in to 2 equal groups:
- Group1: this group will receive immediate loaded screw retained complete overdenture supported by 4 basal implants design .
- Group2 :this group will receive immediate loaded screw retained complete overdenture supported by 4 compressive implants design
- After final implant placements, they will be immediately scanned by intraoral scanner to construct milled in titanium bar which will be immediately loaded into the implants
- Mandibular bar retained complete overdenture will be constructed.
Evaluation will be for:
- Peri implant tissue health that will be measured according to mombelli(12) at the time of insertion(T0), 6months(T1) and 12months (T2).
- Marginal bone height changes will be measured using standardized digital panoramic x-ray(13) after 6months (T0), 12month(T1) and 24months(T2) after prosthesis insertion.
- Periotest will evaluate the stability of the implants during implantation (T0) , 3months(T1) and 6months(T3) following surgery(14) .
- patient satisfaction at T6 for both groups.
- Conditions
- Dental Implant Bone Loss, Peri-Implant Health
- Being tested
- Basal Dental implant, Compressive Dental implant
- Keywords
- Basal compressive implants, complete overdenture for atrophied edentulous mandibular ridge: Clinical and radiographic study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Basal Dental implantDevice
Also called Basal implant group, Immediate loading
Placement of four basal dental implants in the atrophied edentulous mandible followed by immediate loading using a bar-retained mandibular overdenture.
Compressive Dental implantDevice
Placement of four compressive dental implants in the atrophied edentulous mandible followed by immediate loading using a bar-retained mandibular overdenture.
| Study group | Role | What they receive |
|---|---|---|
| Basal implant Group | Experimental | Patients in this group will receive four basal implants placed in the atrophied edentulous mandible. Implants will be immediately loaded using a bar-retained mandibular overdenture. Clinical and radiographic evaluations will be performed to assess implant stability and peri-implant tissue health over the follow-up period.for 3,6,12months intervventions Receives: Device: Basal Dental implant |
| Compressive Dental implant | Experimental | Patients in this group will receive four compressive implants placed in the atrophied edentulous mandible. Implants will be immediately loaded using a bar-retained mandibular overdenture. Clinical and radiographic evaluations will be performed to assess implant stability and peri-implant tissue health over the follow-up period. Receives: Device: Compressive Dental implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peri-implant tissue health
Peri-implant tissue health that will be measured according to mombelli for both groups
Measured: Baseline, 6 months, and 12 months after implant loading.
Marginal bone height changes
Marginal bone height changes will be measured using standardized digital panoramic x-ray for both groups
Measured: Baseline, 6 months, and 12 months after implant loading.
Implant stability
Periotest will evaluate the stability of the implants during implantation for both groups
Measured: Baseline, 3 months, and 6 months after implant loading.
Secondary outcomes (1)
patient satisfaction
patient satisfaction by 14-item Oral Health Impact (OHIP-14) evaluation test
Measured: baseline,6month after implant loading
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study start1 Apr 2026
- Primary completion2 Oct 2026
- Study completion2 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Implant Bone LossStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amany Awad Elsayed Awad, Mansoura University
- Investigators
- Gilan Altonbary, Ass.prof, Study chair, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07588789
- Sponsor's protocol ID
- MDP.25.06.21
- Acronym
- Implants types
- Status last verified
- Mar 2026
- First submitted
- 29 Apr 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Totally research information especially clinical study results data step of researh
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Basal Versus Compressive Implant Designs Immediately Loaded With Bar Retained Complete Overdenture for Atrophied Edentulous Mandibular Ridge: Clinical and Radiographic Study of peri_implant Tissue Health
- ClinicalTrials.gov ID
- NCT07588789
- Acronym / sponsor ID
- Implants types / MDP.25.06.21
- Conditions
- Dental Implant Bone Loss, Peri-Implant Health
- Keywords
- Basal compressive implants, complete overdenture for atrophied edentulous mandibular ridge: Clinical and radiographic study
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 2 Oct 2026 (actual)
- Study completion
- 2 May 2027 (estimated)
- First posted
- 15 May 2026 (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 will be clinical and radio graphical comparison of four basal and compressive implant designs will be installed in the interforamina area of atrophied edentulous mandible and immediately loaded by bar retained mandibular overdenture .
Implant design comparison will be done clinically and radiographically after six month and one year of implant loading
Detailed description
Patients will be divided randomly in to 2 equal groups:
- Group1: this group will receive immediate loaded screw retained complete overdenture supported by 4 basal implants design .
- Group2 :this group will receive immediate loaded screw retained complete overdenture supported by 4 compressive implants design
- After final implant placements, they will be immediately scanned by intraoral scanner to construct milled in titanium bar which will be immediately loaded into the implants
- Mandibular bar retained complete overdenture will be constructed.
Evaluation will be for:
- Peri implant tissue health that will be measured according to mombelli(12) at the time of insertion(T0), 6months(T1) and 12months (T2).
- Marginal bone height changes will be measured using standardized digital panoramic x-ray(13) after 6months (T0), 12month(T1) and 24months(T2) after prosthesis insertion.
- Periotest will evaluate the stability of the implants during implantation (T0) , 3months(T1) and 6months(T3) following surgery(14) .
- patient satisfaction at T6 for both groups.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Basal implant Group | Experimental | Device: Basal Dental implantPatients in this group will receive four basal implants placed in the atrophied edentulous mandible. Implants will be immediately loaded using a bar-retained mandibular overdenture. Clinical and radiographic evaluations will be performed to assess implant stability and peri-implant tissue health over the follow-up period.for 3,6,12months intervventions |
| Compressive Dental implant | Experimental | Device: Compressive Dental implantPatients in this group will receive four compressive implants placed in the atrophied edentulous mandible. Implants will be immediately loaded using a bar-retained mandibular overdenture. Clinical and radiographic evaluations will be performed to assess implant stability and peri-implant tissue health over the follow-up period. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- -
- mandibular and maxillary alveolar ridges are completely edentulous (2) There is not sufficient bone in the mandibular posterior molar area to place implants and there is a thin ridge anteriorly (3) skeletal class I maxilla-mandibular relationship (4) Devoid o f any systemic disorders related to bone resorptio
Key exclusion criteria (1 listed)
- present of systematic disease Chem therapy Bone diseases
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 |
|---|---|---|
| Basal Dental implantAlso: Basal implant group, Immediate loadingPlacement of four basal dental implants in the atrophied edentulous mandible followed by immediate loading using a bar-retained mandibular overdenture. | Device | Basal implant Group |
| Compressive Dental implantPlacement of four compressive dental implants in the atrophied edentulous mandible followed by immediate loading using a bar-retained mandibular overdenture. | Device | Compressive Dental implant |
Primary outcome
Peri-implant tissue health
Time frame: Baseline, 6 months, and 12 months after implant loading.
Peri-implant tissue health that will be measured according to mombelli for both groups
Marginal bone height changes
Time frame: Baseline, 6 months, and 12 months after implant loading.
Marginal bone height changes will be measured using standardized digital panoramic x-ray for both groups
Implant stability
Time frame: Baseline, 3 months, and 6 months after implant loading.
Periotest will evaluate the stability of the implants during implantation for both groups
1 secondary outcome
patient satisfaction
Time frame: baseline,6month after implant loading
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 4 Nov 2026.
- Individual participant dataSharing planned: No. Totally research information especially clinical study results data step of researh
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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.
Gilan Altonbary, Ass.prof study chair
Mansoura 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 Basal Dental implant and Compressive Dental implant in people with Dental Implant Bone Loss and Peri-Implant Health, run by Mansoura 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 2 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: under way, not looking for participants, as of the sponsor's last update on 4 Nov 2026. 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?
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?
Peri-implant tissue health (time frame: Baseline, 6 months, and 12 months after implant loading.). The study lists 3 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 4 Nov 2026; AzTrials last refreshed its copy on 7 Nov 2026.