Peri Implant Bone LossNCT06720389
Effect of Two Different Digital Construction Techniques of Implant-assisted Overdentures
A study testing peri implant bone loss was assessed by CBCT and posterior ridge resorption was assessed by CBCT in people with Peri Implant Bone Loss, run by Mansoura University at 1 site in Egypt.
Trial summary
twenty patients received mandibular overdenture constructed by different construction techniques were classified equally and randomly into two groups peri implant bone loss was assessed by CBCT at baseline (T0), at1 year(T1), at 3 years(T3) and posterior ridge resorption was assessed by CBCT at baseline (T0), at 1… Read more about this study
- Who is it for?
- Ages 50 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Peri Implant Bone Loss
- What is being tested?
- peri implant bone loss was assessed by CBCT and posterior ridge resorption was assessed by CBCT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Oct 2022to 6 Nov 2024
- 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 50 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All patient wearing maxillary conventional denture.
- All patients had temporary mandibular overdenture supported by vertically inserted 4-implant at least six months ago.
- A Cone Beam Computed Tomography (CBCT) done to verify the accurate position and success of the inserted implant.
- They were healthy, free from any systemic diseases relating to bone resorption such as uncontrolled diabetics or osteoporosis. This was achieved through medical history and clinical examination by physician.
- At least 15 mm restorative space must be available (from the mucosa covering the crest of the residual ridge to proposed occlusal plane) to permit construction of all types of tested prosthesis (class I according to Ahuja and Cagna). This was detected by a tentative jaw relation.
- All patients are of angel's class I maxillo-mandibular relationships.
Who cannot join
- Patients had head and neck radiotherapy, patients with bleeding disorders or hepatic patients.
- Patients with metabolic disorders as diabetes mellitus, osteoporosis and hepatic disorders that might affect osseointegration.
- Long term immunosuppress and corticosteroid drug therapy.
- Patient with abnormal habits as clenching and bruxism.
- Smoking patient.
- Uncooperative patients.
- Neuromuscular diseases.
- Patient with problems in TMJ.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Two Different Digital Construction Techniques of Implant-assisted Overdentures: a 3-year Prospective Radiographic Study
twenty patients received mandibular overdenture constructed by different construction techniques were classified equally and randomly into two groups peri implant bone loss was assessed by CBCT at baseline (T0), at1 year(T1), at 3 years(T3) and posterior ridge resorption was assessed by CBCT at baseline (T0), at 1 year( T1), at 3 years (T3). By superimposition of pre and post CBCT.
Read the detailed description
twenty patients received mandibular overdenture constructed by different construction techniques were classified equally and randomly into two groups (n = 10 per group): Group A: received milled mandibular overdenture opposed by maxillary complete denture. Group B: received 3D-printed mandibular overdenture opposed by maxillary acrylic complete denture. peri implant bone loss was assessed by CBCT at baseline (T0), at1 year(T1), at 3 years(T3) and posterior ridge resorption was assessed by CBCT at baseline (T0), at 1 year( T1), at 3 years (T3). By superimposition of pre and post CBCT.
- Conditions
- Peri Implant Bone Loss
- Being tested
- peri implant bone loss was assessed by CBCT, posterior ridge resorption was assessed by CBCT
- Keywords
- Milled denture base, 3D-printing denture base,
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
peri implant bone loss was assessed by CBCTRadiation
using CBCT, vertical bone loss (VBL) was measured at baseline (T0), at1 year(T1), at 3 years(T3)
posterior ridge resorption was assessed by CBCTOther
posterior ridge resorption was assessed by CBCT at baseline (T0), at 1 year( T1), at 3 years (T3). By superimposition of pre and post CBCT.
| Study group | Role | What they receive |
|---|---|---|
| milled mandibular overdenture opposed by maxillary complete denture | Active comparator | A denture base milled from a pre-polymerized block of polymethylmethacrylate (Ivobase CAD) along with milled denture teeth from a block of tooth coloured material PMMA (SR Vivodent CAD). Receives: Radiation: peri implant bone loss was assessed by CBCT; Other: posterior ridge resorption was assessed by CBCT |
| 3D-Printed mandibular overdenture | Active comparator | The printer (Rasdent 3d printer) was loaded with material of 3D-printed denture base and 3D- printed denture teeth (Dentca denture teeth shade A2). The mandibular denture teeth were printed as one unit then bonded to the lower printed denture base. Receives: Radiation: peri implant bone loss was assessed by CBCT; Other: posterior ridge resorption was assessed by CBCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
peri implant bone loss
peri implant bone loss was assessed by CBCT
Measured: at baseline (T0), at1 year(T1), at 3 years(T3)
posterior ridge resorption
posterior ridge resorption was assessed by CBCT at baseline (T0), at 1 year( T1), at 3 years (T3). By superimposition of pre and post CBCT.
Measured: at baseline (T0), at 1 year( T1), at 3 years (T3).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2024
- Study start12 Oct 2022
- Primary completion4 Aug 2024
- Study completion6 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peri 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06720389
- Sponsor's protocol ID
- A01010024RP
- Status last verified
- Dec 2024
- First submitted
- 3 Dec 2024
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
El Khamisy NES, Emera RMK, Elmanci TM, Aboelez MA. Effect of two different digital construction techniques of mandibular implant-assisted overdentures on peri-implant bone loss and posterior ridge resorption: a 3-year prospective randomized clinical trial. BMC Oral Health. 2025 Jul 2;25(1):1040. doi: 10.1186/s12903-025-06425-0.
PubMed 40604700
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Two Different Digital Construction Techniques of Implant-assisted Overdentures: a 3-year Prospective Radiographic Study
- ClinicalTrials.gov ID
- NCT06720389
- Acronym / sponsor ID
- A01010024RP
- Conditions
- Peri Implant Bone Loss
- Keywords
- Milled denture base, 3D-printing denture base,
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 12 Oct 2022 (actual)
- Primary completion
- 4 Aug 2024 (actual)
- Study completion
- 6 Nov 2024 (actual)
- First posted
- 6 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.
twenty patients received mandibular overdenture constructed by different construction techniques were classified equally and randomly into two groups peri implant bone loss was assessed by CBCT at baseline (T0), at1 year(T1), at 3 years(T3) and posterior ridge resorption was assessed by CBCT at baseline (T0), at 1 year( T1), at 3 years (T3). By superimposition of pre and post CBCT.
Detailed description
twenty patients received mandibular overdenture constructed by different construction techniques were classified equally and randomly into two groups (n = 10 per group): Group A: received milled mandibular overdenture opposed by maxillary complete denture. Group B: received 3D-printed mandibular overdenture opposed by maxillary acrylic complete denture. peri implant bone loss was assessed by CBCT at baseline (T0), at1 year(T1), at 3 years(T3) and posterior ridge resorption was assessed by CBCT at baseline (T0), at 1 year( T1), at 3 years (T3). By superimposition of pre and post CBCT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| milled mandibular overdenture opposed by maxillary complete denture | Active comparator | Radiation: peri implant bone loss was assessed by CBCT, Other: posterior ridge resorption was assessed by CBCTA denture base milled from a pre-polymerized block of polymethylmethacrylate (Ivobase CAD) along with milled denture teeth from a block of tooth coloured material PMMA (SR Vivodent CAD). |
| 3D-Printed mandibular overdenture | Active comparator | Radiation: peri implant bone loss was assessed by CBCT, Other: posterior ridge resorption was assessed by CBCTThe printer (Rasdent 3d printer) was loaded with material of 3D-printed denture base and 3D- printed denture teeth (Dentca denture teeth shade A2). The mandibular denture teeth were printed as one unit then bonded to the lower printed denture base. |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- All patient wearing maxillary conventional denture.
- All patients had temporary mandibular overdenture supported by vertically inserted 4-implant at least six months ago.
- A Cone Beam Computed Tomography (CBCT) done to verify the accurate position and success of the inserted implant.
- They were healthy, free from any systemic diseases relating to bone resorption such as uncontrolled diabetics or osteoporosis. This was achieved through medical history and clinical examination by physician.
- At least 15 mm restorative space must be available (from the mucosa covering the crest of the residual ridge to proposed occlusal plane) to permit construction of all types of tested prosthesis (class I according to Ahuja and Cagna). This was detected by a tentative jaw relation.
Key exclusion criteria (8 listed)
- Patients had head and neck radiotherapy, patients with bleeding disorders or hepatic patients.
- Patients with metabolic disorders as diabetes mellitus, osteoporosis and hepatic disorders that might affect osseointegration.
- Long term immunosuppress and corticosteroid drug therapy.
- Patient with abnormal habits as clenching and bruxism.
- Smoking patient.
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 |
|---|---|---|
| peri implant bone loss was assessed by CBCTusing CBCT, vertical bone loss (VBL) was measured at baseline (T0), at1 year(T1), at 3 years(T3) | Radiation | 3D-Printed mandibular overdenture, milled mandibular overdenture opposed by maxillary complete denture |
| posterior ridge resorption was assessed by CBCTposterior ridge resorption was assessed by CBCT at baseline (T0), at 1 year( T1), at 3 years (T3). By superimposition of pre and post CBCT. | Other | 3D-Printed mandibular overdenture, milled mandibular overdenture opposed by maxillary complete denture |
Primary outcome
peri implant bone loss
Time frame: at baseline (T0), at1 year(T1), at 3 years(T3)
peri implant bone loss was assessed by CBCT
posterior ridge resorption
Time frame: at baseline (T0), at 1 year( T1), at 3 years (T3).
posterior ridge resorption was assessed by CBCT at baseline (T0), at 1 year( T1), at 3 years (T3). By superimposition of pre and post 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 18 Dec 2024.
- Derived from this study: PubMed 40604700El Khamisy NES, Emera RMK, Elmanci TM, Aboelez MA. Effect of two different digital construction techniques of mandibular implant-assisted overdentures on peri-implant bone loss and posterior ridge resorption: a 3-year prospective randomized clinical trial. BMC Oral Health. 2025 Jul 2;25(1):1040. doi: 10.1186/s12903-025-06425-0.
- Individual participant dataSharing planned: No
Related trials for Peri Implant Bone Loss
Active, not recruiting
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
Dental Implant Bone Loss, Peri-Implant Health
Active, not recruiting
Influence of Implant Insertion Depth on Peri-implant Bone Changes Around Short Implants
Tooth Loss, Edentulism
Not yet recruitingObservational study
Diagnostic Accuracy of Large Language Models for Peri-Implant Marginal Bone Loss on Panoramic Radiographs
Peri-implantitis, Alveolar Bone Loss
RecruitingObservational study
Access to Probing and Peri-implant Diseases
Peri-implantitis, Peri-implant Bone Loss
RecruitingObservational study
Markers of Bone Destruction and Oxidative Stress in Peri-implantitis
Periodontal Diseases, Periimplant Diseases
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 peri implant bone loss was assessed by CBCT and posterior ridge resorption was assessed by CBCT in people with Peri Implant Bone Loss, 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 6 inclusion and 8 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 18 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?
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?
peri implant bone loss (time frame: at baseline (T0), at1 year(T1), at 3 years(T3)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06720389, which also lists 1 linked publication.
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 18 Dec 2024.