Implant Supported OverdentureIODsNCT07580534
Clinical Evaluation of Conventional and 3D-printed Implant-supported Overdentures Retained With New Attachment Systems
A study testing Crossover Assignment in people with Implant Supported Overdenture and Wear, Occlusal, run by Al-Azhar University at 1 site in Egypt.
Trial summary
Randomized Crossover Clinical Trial Comparing Two Denture Designs (A and B) Retained by Two Locator Systems (ST and EMI) in Implant Overdenture Patients Read more about this study
- Who is it for?
- Ages Up to 70 years
- Conditions the study is for
- Implant Supported Overdenture, Wear, Occlusal
- What is being tested?
- Crossover Assignment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2024to Aug 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 Up to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Completely edentulous patients
- Non-smokers
- Patients free from intra-oral diseases that may affect implant-overdenture prognosis
- Patients free from systemic conditions that may influence bone resorption or implant success
- Able and willing to comply with study visits and follow-up schedule
Who cannot join
- Smokers or tobacco users
- Presence of active oral lesions, infections, or mucosal pathology
- Systemic diseases affecting bone metabolism (e.g., uncontrolled diabetes, osteoporosis requiring bisphosphonates)
- History of head and neck radiation
- Severe parafunctional habits (e.g., bruxism)
- Inability to attend follow-up appointments or provide informed consent
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
Faculty of Dental Medicine, Al-Azhar University, (Assiut Branch)
Asyut
About this study
Randomized Crossover Clinical Trial Comparing Two Denture Designs (A and B) Retained by Two Locator Systems (ST and EMI) in Implant Overdenture Patients
Read the detailed description
This randomized crossover clinical trial evaluates patient-reported outcomes and clinical performance of implant overdentures (IODs) using two different denture designs (A and B) retained by two locator attachment systems: Locator ST and Locator EMI. Each participant will receive both denture designs in a crossover sequence, allowing direct within-subject comparison.
- Conditions
- Implant Supported Overdenture, Wear, Occlusal
- Being tested
- Crossover Assignment
- Keywords
- Implant overdentures (IODs), Denture wear, Peri-implant soft tissue health, Crossover clinical trial, Prosthodontic outcomes, attachment system
- Medical subject headings
- Tooth Attrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Crossover AssignmentOther
Participants receive Denture A, a conventional mandibular implant overdenture, retained by two Locator ST attachments placed in the interforaminal region. Outcomes include OHIP-19, VAS satisfaction, retention force, attachment wear, periodontal parameters, and denture tooth wear resistance.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Denture A with Locator ST Participants receive Denture A retained by Locator ST attachments. | Experimental | Participants receive Denture A retained by Locator ST attachments. Receives: Other: Crossover Assignment |
| Denture A with Locator EMI | Experimental | Participants receive Denture A retained by two Locator EMI attachments. Same outcome measures as above, allowing comparison of attachment type influence on patient-reported and clinical outcomes. Receives: Other: Crossover Assignment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention Force of Implant Overdentures (IODs)
Retention force measured using a digital force gauge to quantify the dislodgement force required to remove the overdenture from the implants. Measurements will be reported in Newtons (N).
Measured: Outcome measures were assessed at four clearly defined time points: 1. Baseline (Immediately after overdenture pick up) 2. 3 month follow up 3. 6 month follow up 4. 9 month follow up These time points correspond to the evaluation of implant overdentures
Denture Wear of Implant Overdentures (IODs)
Denture wear assessed by measuring surface loss on occlusal surface using digital analysis. Wear depth recorded in millimeters (mm) at each evaluation point.
Measured: Wear was evaluated relative to the baseline measurement taken immediately after pick-up, with follow-up assessment 9-month per denture type: 1. 3 month follow up 2. 6 month follow up 3. 9 month follow up
Peri-implant Soft Tissue Health (Modified Plaque Index and Modified Bleeding Index Scores)
Peri-implant soft tissue health assessed using the Modified Plaque Index (mPI) and Modified Bleeding Index (mBI).
Both indices are ordinal clinical scales scored according to standard peri-implant evaluation criteria:
mPI range: 0-3 0 = no plaque 3 = abundant plaque
mBI range: 0-3 0 = no bleeding 3 = profuse bleeding
Interpretation:
Higher scores indicate worse peri-implant soft tissue health.
Unit of Measure:
Ordinal index scores (mPI, mBI)
Measured: Assessments performed over an 18-month total follow-up period, at the following intervals: 1 - Immediately after pick-up (baseline) 2 - 3 months 3 - 6 months 4 - 9 months 5 - 12 months 6 - 15 months 7 - 18 months
Crestal bone level changes
Crestal bone levels measured on standardized periapical radiographs taken with a paralleling technique. Bone level is defined as the distance from the implant shoulder to the first bone-to-implant contact.
Measured: Radiographic measurements performed over an 18-month total follow-up period, at the following intervals: 1 - Immediately after pick-up (baseline) 2 - 3 months 3 - 6 months 4 - 9 months 5 - 12 months 6 - 15 months 7 - 18 months
Oral Health-Related Quality of Life (OHIP-19 score)
Oral health-related quality of life assessed using the Oral Health Impact Profile-19 (OHIP-19) questionnaire. The OHIP-19 consists of 19 items, each scored on a 5-point ordinal scale from 0 to 4:
0 = never 4 = very often
Minimum score: 0 Maximum score: 76 Interpretation: Higher scores indicate worse oral health-related quality of life.
Measured: OHIP-19 scores recorded three times during each 9-month denture phase: 1 -Before pick-up 2 - Immediately after pick-up 3 - At 9 months follow up
Patient Satisfaction (Visual Analog Scale Score)
Patient satisfaction with the denture and attachment system measured using a 10-point Visual Analog Scale (VAS).
Participants rated their satisfaction on a scale from 0 to 10:
0 = completely dissatisfied 10 = completely satisfied
Measured: VAS satisfaction scores recorded three times during each 9-month denture phase: 1 - Before pick-up 2 - Immediately after pick-up 3 - At 9 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start1 Jun 2024
- Primary completionJun 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Implant Supported OverdentureStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This randomized crossover clinical trial investigates the impact of two different denture designs (Denture A and Denture B) retained by two locator attachment systems (Locator ST and Locator EMI) in patients rehabilitated with mandibular implant overdentures (IODs). The study aims to evaluate both clinical performance and patient-reported outcomes, providing a comprehensive assessment of treatment effectiveness. Each participant receives both denture designs in a crossover sequence, allowing direct within-subject comparison and minimizing inter-patient variability. The locator systems (ST and EMI) are tested with each denture design to determine whether attachment type influences patient satisfaction, prosthesis function, and oral health-related quality of life. Primary outcomes are measured using the Arabic version of the Oral Health Impact Profile-19 (OHIP-19) and Visual Analog Scales (VAS) for satisfaction domains (comfort, chewing ability, speech clarity, esthetics, and retention
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Moustafa, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07580534
- Sponsor's protocol ID
- Al-Azhar University, (Assiut B
- Acronym
- IODs
- Status last verified
- Apr 2026
- First submitted
- 25 Apr 2026
- Last updated
- 12 May 2026
- 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 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Conventional and 3D-printed Implant-supported Overdentures Retained With New Attachment Systems
- ClinicalTrials.gov ID
- NCT07580534
- Acronym / sponsor ID
- IODs / Al-Azhar University, (Assiut B
- Conditions
- Implant Supported Overdenture, Wear, Occlusal
- Keywords
- Implant overdentures (IODs), Denture wear, Peri-implant soft tissue health, Crossover clinical trial, Prosthodontic outcomes, attachment system
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 12 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.
Randomized Crossover Clinical Trial Comparing Two Denture Designs (A and B) Retained by Two Locator Systems (ST and EMI) in Implant Overdenture Patients
Detailed description
This randomized crossover clinical trial evaluates patient-reported outcomes and clinical performance of implant overdentures (IODs) using two different denture designs (A and B) retained by two locator attachment systems: Locator ST and Locator EMI. Each participant will receive both denture designs in a crossover sequence, allowing direct within-subject comparison.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This randomized crossover clinical trial investigates the impact of two different denture designs (Denture A and Denture B) retained by two locator attachment systems (Locator ST and Locator EMI) in patients rehabilitated with mandibular implant overdentures (IODs). The study aims to evaluate both clinical performance and patient-reported outcomes, providing a comprehensive assessment of treatment effectiveness. Each participant receives both denture designs in a crossover sequence, allowing direct within-subject comparison and minimizing inter-patient variability. The locator systems (ST and EMI) are tested with each denture design to determine whether attachment type influences patient satisfaction, prosthesis function, and oral health-related quality of life. Primary outcomes are measured using the Arabic version of the Oral Health Impact Profile-19 (OHIP-19) and Visual Analog Scales (VAS) for satisfaction domains (comfort, chewing ability, speech clarity, esthetics, and retention
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Denture A with Locator ST Participants receive Denture A retained by Locator ST attachments. | Experimental | Other: Crossover AssignmentParticipants receive Denture A retained by Locator ST attachments. |
| Denture A with Locator EMI | Experimental | Other: Crossover AssignmentParticipants receive Denture A retained by two Locator EMI attachments. Same outcome measures as above, allowing comparison of attachment type influence on patient-reported and clinical outcomes. |
Who may qualify
- Ages
- Up to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Completely edentulous patients
- Non-smokers
- Patients free from intra-oral diseases that may affect implant-overdenture prognosis
- Patients free from systemic conditions that may influence bone resorption or implant success
- Able and willing to comply with study visits and follow-up schedule
Key exclusion criteria (6 listed)
- Smokers or tobacco users
- Presence of active oral lesions, infections, or mucosal pathology
- Systemic diseases affecting bone metabolism (e.g., uncontrolled diabetes, osteoporosis requiring bisphosphonates)
- History of head and neck radiation
- Severe parafunctional habits (e.g., bruxism)
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 |
|---|---|---|
| Crossover AssignmentParticipants receive Denture A, a conventional mandibular implant overdenture, retained by two Locator ST attachments placed in the interforaminal region. Outcomes include OHIP-19, VAS satisfaction, retention force, attachment wear, periodontal parameters, and denture tooth wear resistance. | Other | Arm 1: Denture A with Locator ST Participants receive Denture A retained by Locator ST attachments., Denture A with Locator EMI |
Primary outcome
Retention Force of Implant Overdentures (IODs)
Time frame: Outcome measures were assessed at four clearly defined time points: 1. Baseline (Immediately after overdenture pick up) 2. 3 month follow up 3. 6 month follow up 4. 9 month follow up These time points correspond to the evaluation of implant overdentures
Retention force measured using a digital force gauge to quantify the dislodgement force required to remove the overdenture from the implants. Measurements will be reported in Newtons (N).
Denture Wear of Implant Overdentures (IODs)
Time frame: Wear was evaluated relative to the baseline measurement taken immediately after pick-up, with follow-up assessment 9-month per denture type: 1. 3 month follow up 2. 6 month follow up 3. 9 month follow up
Denture wear assessed by measuring surface loss on occlusal surface using digital analysis. Wear depth recorded in millimeters (mm) at each evaluation point.
Peri-implant Soft Tissue Health (Modified Plaque Index and Modified Bleeding Index Scores)
Time frame: Assessments performed over an 18-month total follow-up period, at the following intervals: 1 - Immediately after pick-up (baseline) 2 - 3 months 3 - 6 months 4 - 9 months 5 - 12 months 6 - 15 months 7 - 18 months
Peri-implant soft tissue health assessed using the Modified Plaque Index (mPI) and Modified Bleeding Index (mBI). Both indices are ordinal clinical scales scored according to standard peri-implant evaluation criteria: mPI range: 0-3 0 = no plaque 3 = abundant plaque mBI range: 0-3 0 = no bleeding 3 = profuse bleeding Interpretation: Higher scores indicate worse peri-implant soft tissue health. Unit of Measure: Ordinal index scores (mPI, mBI)
Crestal bone level changes
Time frame: Radiographic measurements performed over an 18-month total follow-up period, at the following intervals: 1 - Immediately after pick-up (baseline) 2 - 3 months 3 - 6 months 4 - 9 months 5 - 12 months 6 - 15 months 7 - 18 months
Crestal bone levels measured on standardized periapical radiographs taken with a paralleling technique. Bone level is defined as the distance from the implant shoulder to the first bone-to-implant contact.
Oral Health-Related Quality of Life (OHIP-19 score)
Time frame: OHIP-19 scores recorded three times during each 9-month denture phase: 1 -Before pick-up 2 - Immediately after pick-up 3 - At 9 months follow up
Oral health-related quality of life assessed using the Oral Health Impact Profile-19 (OHIP-19) questionnaire. The OHIP-19 consists of 19 items, each scored on a 5-point ordinal scale from 0 to 4: 0 = never 4 = very often Minimum score: 0 Maximum score: 76 Interpretation: Higher scores indicate worse oral health-related quality of life.
Patient Satisfaction (Visual Analog Scale Score)
Time frame: VAS satisfaction scores recorded three times during each 9-month denture phase: 1 - Before pick-up 2 - Immediately after pick-up 3 - At 9 months follow up
Patient satisfaction with the denture and attachment system measured using a 10-point Visual Analog Scale (VAS). Participants rated their satisfaction on a scale from 0 to 10: 0 = completely dissatisfied 10 = completely satisfied
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 May 2026.
- Individual participant dataSharing planned: No
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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.
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 Crossover Assignment in people with Implant Supported Overdenture and Wear, Occlusal, 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 5 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: enrolling by invitation, as of the sponsor's last update on 12 May 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?
Retention Force of Implant Overdentures (IODs) (time frame: Outcome measures were assessed at four clearly defined time points: 1. Baseline (Immediately after overdenture pick up) 2. 3 month follow up 3. 6 month follow up 4. 9 month follow up These time points correspond to the evaluation of implant overdentures). The study lists 6 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 12 May 2026.