Dental ImplantNCT07256106
Occlusion and Dis-Occlusion Time in Mandibular Overdentures Supported by Conventional Versus Mini- Dental Implants
A study testing mini dental implant and conventional dental implant in people with Dental Implant and Edentulous Mouth, run by Ain Shams University at 2 sites in Egypt.
Trial summary
The aim of the study will be comparing between the occlusion and disocclusion time in mandibular single overdenture supported with immediately loaded two conventional implants versus immediately loaded four mini-implants. Read more about this study
- Who is it for?
- Ages 55 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Implant, Edentulous Mouth
- What is being tested?
- mini dental implant and conventional dental implant
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 2 sitesEgypt
- Study dates
- 29 Nov 2025to 15 Apr 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 55 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients with completely edentulous mandibular ridges and fully dentate or partially dentate maxillary arch restored with fixed restoration,
- enough inter-arch space to allow for prosthetic rehabilitation with lower implant-retained overdentures
- good oral hygiene and motivation.
Who cannot join
- The excluded patients will be patients with major systemic diseases that may affect osseointegration as uncontrolled diabetes mellitus, pregnancy, patients under bisphosphonate treatment.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt2 sites, 2 recruiting
- Recruiting
Faculty of Dentistry Ain Shams University
Cairo, 11361
Ahmed Abdelfattah, BSc, MSc, MD, 01111191337, ahmedmostafa@dent.asu.edu.eg
- Recruiting
Faculty of Dentistry Ain Shams University
Cairo, 11361
Ahmed MA Mohamed, BSC,MSC,MD, 01111191337, AHMEDMOSTAFA@dent.asu.edu.eg
Amr MO Elfiky, BSC,MSC, 01144224292, aaa.fiky@gmail.com
About this study
Official title: Evaluation of The Occlusion and Dis-Occlusion Time in Mandibular Single Overdentures Supported by Conventional Versus Mini- Dental Implants; A Parallel Blinded Randomized Clinical Trial
The aim of the study will be comparing between the occlusion and disocclusion time in mandibular single overdenture supported with immediately loaded two conventional implants versus immediately loaded four mini-implants.
Research question Is there a difference in occlusion and disocclusion time between two mandibular single dentures, one supported by immediately loaded two conventional implants and the second one supported by immediately loaded four mini-implants? Primary outcome: occlusion and disocclusion time Secondary outcome: Kapur index The null hypothesis is that there is no difference between both treatment modalities on occlusion and disocclusion time.
Read the detailed description
Twenty eight patients will be selected to share in this study from the outpatient clinic of Prosthodontics Department, Faculty of Dentistry, Ain-Shams University.
Sample size was calculated according to these values producing a minimal sample size of Twenty eight patients being enough to find such a difference. The size was determined in the light of the study " Computerized occlusal analysis of mini-dental implant-retained mandibular overdentures: A 1-year prospective clinical study " 34 with alpha error probability of 0.05, 1-beta error probability , power of 0.8 and drop out ratio 5%.
The inclusion criteria will be patients with completely edentulous lower ridges and fully dentate or partially dentate maxillary arch restored with fixed restoration, exhibiting enough inter-arch space to allow for prosthetic rehabilitation with lower implant-retained overdentures and have good oral hygiene and motivation. The excluded patients will be patients with major systemic diseases that may affect osseointegration as uncontrolled diabetes mellitus, pregnancy, patients under bisphosphonate treatment.
The patients will make a complete oral and radiographic examination before inclusion in this study.
For allocation concealment, one of the postgraduate students who will be the only one to know the key so that the authors and the patients won't know in which group the patient will be. Afterwards, the authors will be informed by the randomization to be tabulated.
Ethical approval will be granted by the research ethics committee in the Faculty of Dentistry Ain Shams University (FDASUREC). All patients will be informed in details about the nature of the investigation and the aim of the study. Patients' data will be kept safe and confidential to protect the security and privacy of the patient information. All participants will be given notice about their privacy and their rights.
The patients will be divided into two equal groups; group (CI) and group (MI). Group CI patients will be rehabilitated with mandibular overdentures retained by two immediately loaded conventional implants inserted in the inter-foraminal region.
Group MI patients will be rehabilitated with single mandibular overdentures retained by four immediately loaded mini implants inserted in the inter-foraminal region.
During the first appointment, medical history, clinical and radiological evaluation will be recorded to verify the eligibility of each subject. To assess the residual bone anatomy, a CBCT scan will be performed according to the manufacturer's instructions with a proper field-of-view size to include both the upper and lower jaw. All patients were rehabilitated with complete single mandibular dentures prior to implant insertion. A radiopaque markers will be added to the patient's mandibular denture to make a radiographic stent. For each patient in both groups a CBCT will be made while wearing the radiographic stent.
Surgical procedures:
All surgical procedures will be performed under local anesthesia on an outpatient basis by the same surgical team.
For group CI patient, two screw type conventional implants will be inserted in the symphesial region. Crestal incision extending about 5 mm distal to each proposed implant sites will be made. A full thickness mucoperiosteal flap will be reflected exposing the bone in the proposed area.
A round bur will be used to mark the implant sites guided by the surgical stent. Preparation of implant site will start with the pilot drill placed parallel to the midline in both implant sites. Two paralleling tools will be used to check parallelism. The osteotomy preparation will be continued until the final drill. Implants will be threaded in place and the mucoperiosteal flap will be repositioned and sutured.
For group MI patient, four screw type one piece mini dental implants will be inserted in the predetermined implant sites in the symphesial region. The position of the two distal implants will be marked 6 mm mesial to each mental foramen. The position of the other two implants will be marked equidistant from the distal implants with and at least 5 mm apart.
At the marked implant site, Cortical drill will be used to penetrate cortical bone. A pilot drill will be used to drill bone up and down in a vertical direction until the desired length reached. The implant will be picked up from the sterile vial and directly inserted into the prepared site.
Post-surgical procedures:
After the surgery, areas opposing to the inserted implants will be marked on the fitting surfaces of the mandibular single denture. Abrasive stone will be used to relieve the marked areas and create enough space for the metal housing, The metal housings will be seated on the implant heads. The denture will be placed in the patient's mouth to check and ensure complete seating and proper inter-cuspal relation. Auto-polymerized dough acrylic resin will be mixed and added to the relieved areas and the denture will be reseated inside the patient's mouth. Patients will be instructed to close in centric until complete polymerization take place. The lower single denture will be removed from the patient's mouth with the metal housings in the fitting surface. The excess acrylic resin will be removed.
Method of evaluation:
Occlusal parameters: occlusion time (OT) and disocclusion time (DT) will be recorded for each patient. The patient will be asked to close on sensor in centric occlusion holding their teeth together for 1 to 3 seconds then start right eccentric movement until disoccluding their teeth. The patient will then be asked to close on sensor in centric occlusion holding their teeth together for 1 to 3 seconds then start left eccentric movement until disoccluding their teeth. This will be repeated 4 times for the right excursion (DT-right) and 4 times for the left excursion (DT-left). OT, DT-right, and DT-left were then calculated by taking the averages of the recordings.
The retention and stability of the conventional dentures will be assessed intra-orally by a single experienced examiner using the modified Kapur criteria (Olshan modification).
- Conditions
- Dental Implant, Edentulous Mouth
- Being tested
- mini dental implant, conventional dental implant
- Keywords
- occlusion time, disocclusion time
- Medical subject headings
- Mouth, Edentulous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mini dental implantProcedure or surgery
For group MI patient, four screw type one piece mini dental implants will be inserted in the predetermined implant sites in the symphesial region. The position of the two distal implants will be marked 6 mm mesial to each mental foramen. The position of the other two implants will be marked equidistant from the distal implants with and at least 5 mm apart
conventional dental implantProcedure or surgery
For group CI patient, two screw type conventional implants will be inserted in the symphesial region.
| Study group | Role | What they receive |
|---|---|---|
| conventional implant supported mandibular overdenture | Active comparator | Group CI patients will be rehabilitated with mandibular overdentures retained by two immediately loaded conventional implants inserted in the inter-foraminal region. Receives: Procedure: conventional dental implant |
| mini-implant supported mandibular overdenture | Experimental | Group MI patients will be rehabilitated with single mandibular overdentures retained by four immediately loaded mini implants inserted in the inter-foraminal region. Receives: Procedure: mini dental implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
occlusion/dis occlusion time
Occlusal parameters: occlusion time (OT) and disocclusion time (DT) will be recorded for each patient. The patient will be asked to close on sensor in centric occlusion holding their teeth together for 1 to 3 seconds then start right eccentric movement until disoccluding their teeth. This will be repeated 4 times for the right excursion (DT-right) and 4 times for the left excursion (DT-left). OT, DT-right, and DT-left were then calculated by taking the averages of the recordings.
Measured: 1 year
Secondary outcomes (1)
denture stability
stability of the over dentures will be assessed intra-orally by a single experienced examiner using the modified Kapur criteria (Olshan modification).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2025
- Study start29 Nov 2025
- Primary completion31 Mar 2026 (estimated)
- Study completion15 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental ImplantStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Model description
- Randomized Controlled Trial (RCT) with parallel assignment of the participants in two groups in ratio 1:1. Randomization will be guided by a computer-generated list. Both groups will be placed in twenty eight numbered closed opaque sealed envelopes according to the computer generated list of random numbers and an envelope will be allocated to each patient. For allocation concealment, one of the postgraduate students who will be the only one to know the key so that the authors and the patients won't know in which group the patient will be. Afterwards, the authors will be informed by the randomization to be tabulated.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mostafa Abdelfatah, Ain Shams University
- Investigators
- Ahmed Mohamed, MD, Principal investigator, Faculty of dentistry, ain shams university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07256106
- Sponsor's protocol ID
- FDASU-RECIR072505
- Status last verified
- Dec 2025
- First submitted
- 20 Nov 2025
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of The Occlusion and Dis-Occlusion Time in Mandibular Single Overdentures Supported by Conventional Versus Mini- Dental Implants; A Parallel Blinded Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07256106
- Acronym / sponsor ID
- FDASU-RECIR072505
- Conditions
- Dental Implant, Edentulous Mouth
- Keywords
- occlusion time, disocclusion time
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 29 Nov 2025 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 15 Apr 2026 (estimated)
- First posted
- 1 Dec 2025 (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 study will be comparing between the occlusion and disocclusion time in mandibular single overdenture supported with immediately loaded two conventional implants versus immediately loaded four mini-implants.
Research question Is there a difference in occlusion and disocclusion time between two mandibular single dentures, one supported by immediately loaded two conventional implants and the second one supported by immediately loaded four mini-implants? Primary outcome: occlusion and disocclusion time Secondary outcome: Kapur index The null hypothesis is that there is no difference between both treatment modalities on occlusion and disocclusion time.
Detailed description
Twenty eight patients will be selected to share in this study from the outpatient clinic of Prosthodontics Department, Faculty of Dentistry, Ain-Shams University.
Sample size was calculated according to these values producing a minimal sample size of Twenty eight patients being enough to find such a difference. The size was determined in the light of the study " Computerized occlusal analysis of mini-dental implant-retained mandibular overdentures: A 1-year prospective clinical study " 34 with alpha error probability of 0.05, 1-beta error probability , power of 0.8 and drop out ratio 5%.
The inclusion criteria will be patients with completely edentulous lower ridges and fully dentate or partially dentate maxillary arch restored with fixed restoration, exhibiting enough inter-arch space to allow for prosthetic rehabilitation with lower implant-retained overdentures and have good oral hygiene and motivation. The excluded patients will be patients with major systemic diseases that may affect osseointegration as uncontrolled diabetes mellitus, pregnancy, patients under bisphosphonate treatment.
The patients will make a complete oral and radiographic examination before inclusion in this study.
For allocation concealment, one of the postgraduate students who will be the only one to know the key so that the authors and the patients won't know in which group the patient will be. Afterwards, the authors will be informed by the randomization to be tabulated.
Ethical approval will be granted by the research ethics committee in the Faculty of Dentistry Ain Shams University (FDASUREC). All patients will be informed in details about the nature of the investigation and the aim of the study. Patients' data will be kept safe and confidential to protect the security and privacy of the patient information. All participants will be given notice about their privacy and their rights.
The patients will be divided into two equal groups; group (CI) and group (MI). Group CI patients will be rehabilitated with mandibular overdentures retained by two immediately loaded conventional implants inserted in the inter-foraminal region.
Group MI patients will be rehabilitated with single mandibular overdentures retained by four immediately loaded mini implants inserted in the inter-foraminal region.
During the first appointment, medical history, clinical and radiological evaluation will be recorded to verify the eligibility of each subject. To assess the residual bone anatomy, a CBCT scan will be performed according to the manufacturer's instructions with a proper field-of-view size to include both the upper and lower jaw. All patients were rehabilitated with complete single mandibular dentures prior to implant insertion. A radiopaque markers will be added to the patient's mandibular denture to make a radiographic stent. For each patient in both groups a CBCT will be made while wearing the radiographic stent.
Surgical procedures:
All surgical procedures will be performed under local anesthesia on an outpatient basis by the same surgical team.
For group CI patient, two screw type conventional implants will be inserted in the symphesial region. Crestal incision extending about 5 mm distal to each proposed implant sites will be made. A full thickness mucoperiosteal flap will be reflected exposing the bone in the proposed area.
A round bur will be used to mark the implant sites guided by the surgical stent. Preparation of implant site will start with the pilot drill placed parallel to the midline in both implant sites. Two paralleling tools will be used to check parallelism. The osteotomy preparation will be continued until the final drill. Implants will be threaded in place and the mucoperiosteal flap will be repositioned and sutured.
For group MI patient, four screw type one piece mini dental implants will be inserted in the predetermined implant sites in the symphesial region. The position of the two distal implants will be marked 6 mm mesial to each mental foramen. The position of the other two implants will be marked equidistant from the distal implants with and at least 5 mm apart.
At the marked implant site, Cortical drill will be used to penetrate cortical bone. A pilot drill will be used to drill bone up and down in a vertical direction until the desired length reached. The implant will be picked up from the sterile vial and directly inserted into the prepared site.
Post-surgical procedures:
After the surgery, areas opposing to the inserted implants will be marked on the fitting surfaces of the mandibular single denture. Abrasive stone will be used to relieve the marked areas and create enough space for the metal housing, The metal housings will be seated on the implant heads. The denture will be placed in the patient's mouth to check and ensure complete seating and proper inter-cuspal relation. Auto-polymerized dough acrylic resin will be mixed and added to the relieved areas and the denture will be reseated inside the patient's mouth. Patients will be instructed to close in centric until complete polymerization take place. The lower single denture will be removed from the patient's mouth with the metal housings in the fitting surface. The excess acrylic resin will be removed.
Method of evaluation:
Occlusal parameters: occlusion time (OT) and disocclusion time (DT) will be recorded for each patient. The patient will be asked to close on sensor in centric occlusion holding their teeth together for 1 to 3 seconds then start right eccentric movement until disoccluding their teeth. The patient will then be asked to close on sensor in centric occlusion holding their teeth together for 1 to 3 seconds then start left eccentric movement until disoccluding their teeth. This will be repeated 4 times for the right excursion (DT-right) and 4 times for the left excursion (DT-left). OT, DT-right, and DT-left were then calculated by taking the averages of the recordings.
The retention and stability of the conventional dentures will be assessed intra-orally by a single experienced examiner using the modified Kapur criteria (Olshan modification).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial (RCT) with parallel assignment of the participants in two groups in ratio 1:1. Randomization will be guided by a computer-generated list. Both groups will be placed in twenty eight numbered closed opaque sealed envelopes according to the computer generated list of random numbers and an envelope will be allocated to each patient. For allocation concealment, one of the postgraduate students who will be the only one to know the key so that the authors and the patients won't know in which group the patient will be. Afterwards, the authors will be informed by the randomization to be tabulated.
| Arm | Type | Receives |
|---|---|---|
| conventional implant supported mandibular overdenture | Active comparator | Procedure: conventional dental implantGroup CI patients will be rehabilitated with mandibular overdentures retained by two immediately loaded conventional implants inserted in the inter-foraminal region. |
| mini-implant supported mandibular overdenture | Experimental | Procedure: mini dental implantGroup MI patients will be rehabilitated with single mandibular overdentures retained by four immediately loaded mini implants inserted in the inter-foraminal region. |
Who may qualify
- Ages
- 55 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients with completely edentulous mandibular ridges and fully dentate or partially dentate maxillary arch restored with fixed restoration,
Key exclusion criteria (1 listed)
- The excluded patients will be patients with major systemic diseases that may affect osseointegration as uncontrolled diabetes mellitus, pregnancy, patients under bisphosphonate treatment.
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 |
|---|---|---|
| mini dental implantFor group MI patient, four screw type one piece mini dental implants will be inserted in the predetermined implant sites in the symphesial region. The position of the two distal implants will be marked 6 mm mesial to each mental foramen. The position of the other two implants will be marked equidistant from the distal implants with and at least 5 mm apart | Procedure or surgery | mini-implant supported mandibular overdenture |
| conventional dental implantFor group CI patient, two screw type conventional implants will be inserted in the symphesial region. | Procedure or surgery | conventional implant supported mandibular overdenture |
Primary outcome
occlusion/dis occlusion time
Time frame: 1 year
Occlusal parameters: occlusion time (OT) and disocclusion time (DT) will be recorded for each patient. The patient will be asked to close on sensor in centric occlusion holding their teeth together for 1 to 3 seconds then start right eccentric movement until disoccluding their teeth. This will be repeated 4 times for the right excursion (DT-right) and 4 times for the left excursion (DT-left). OT, DT-right, and DT-left were then calculated by taking the averages of the recordings.
1 secondary outcome
denture stability
Time frame: 1 year
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 30 Dec 2025.
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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.
Ahmed Mohamed, MD principal investigator
Faculty of dentistry, ain shams university
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mini dental implant and conventional dental implant in people with Dental Implant and Edentulous Mouth, run by Ain Shams University at 2 sites 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: looking for participants now, as of the sponsor's last update on 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 ahmed mohamed, MD (01111191337 ext. 002, ahmedmostafa@dent.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
occlusion/dis occlusion time (time frame: 1 year). 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 30 Dec 2025.