Complete EdentulismNCT07804823
Comparison Between OT-Equator Versus Ball and Socket Attachment Systems in Implant-Retained Mandibular Complete Overdentures
A study testing OT Equator Attachment System and Ball and Socket Attachment System in people with Complete Edentulism, run by Al-Azhar University at 1 site in Egypt.
Trial summary
This study compares two different attachment systems, OT Equator and Ball and Socket, used to retain mandibular complete overdentures supported by a single dental implant. The study aims to evaluate and compare the retention of the two attachment systems over a 12-month follow-up period. Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Complete Edentulism
- What is being tested?
- OT Equator Attachment System and Ball and Socket Attachment System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2024to 30 May 2026
- 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 70 years
- All sexes
- No healthy volunteers
- 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.
About this study
This study compares two different attachment systems, OT Equator and Ball and Socket, used to retain mandibular complete overdentures supported by a single dental implant. The study aims to evaluate and compare the retention of the two attachment systems over a 12-month follow-up period. The study will help determine whether one attachment system provides better and more stable retention of the overdenture over time.
Read the detailed description
This randomized clinical study is designed to compare two attachment systems used with single-implant-retained mandibular complete overdentures: the OT Equator and Ball and Socket attachment systems. The study will evaluate how these two attachment designs perform during routine use over a 12-month follow-up period.
Participants will receive a mandibular complete overdenture retained by a single implant placed in the mandibular anterior region. The overdenture will be connected to the implant using one of the two attachment systems under investigation. Participants will be followed regularly to assess changes in the retention of the overdenture over time.
The study is intended to provide clinical evidence regarding the performance and durability of these two commonly used attachment systems and to assist clinicians in selecting an appropriate attachment system for single-implant mandibular overdenture treatment.
- Conditions
- Complete Edentulism
- Being tested
- OT Equator Attachment System, Ball and Socket Attachment System
- Keywords
- Single Implant, Retention Force, Overdenture Retention, Ball and Socket, OT Equator, Mandibular Overdenture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OT Equator Attachment SystemDevice
A single-implant-retained mandibular complete overdenture using an OT Equator attachment system for retention.
Ball and Socket Attachment SystemDevice
A single-implant-retained mandibular complete overdenture using a Ball and Socket attachment system for retention.
| Study group | Role | What they receive |
|---|---|---|
| OT Equator Group | Experimental | Participants will receive a mandibular complete overdenture retained by a single dental implant using an OT Equator attachment system. Receives: Device: OT Equator Attachment System |
| Ball and Socket Group | Experimental | Participants will receive a mandibular complete overdenture retained by a single dental implant using a Ball and Socket attachment system. Receives: Device: Ball and Socket Attachment System |
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: Time Frame: Baseline (immediately after overdenture pick-up), 3 months, 6 months, and 12 months.
Peri implant Soft Tissue Health (Peri Implant Probing Depth )
Peri implant soft tissue health assessed using the Peri Implant Probing Depth (PIPD). Peri-implant probing depth (PIPD) is defined as the distance from the peri-implant mucosal margin to the base of the sulcus. Clinical measurements were performed using a standardized periodontal probe with a 0.5-mm diameter tip.
Measured: Assessments performed over an 12 month total follow up period, at the following intervals: Immediately after pick up (baseline), 3 months, 6 months, and 12 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 12 month total follow up period, at the following intervals: 1 - Immediately after pick up (baseline) 2 - 3 months 3 - 6 months 4 - 12 months.
Peri implant Soft Tissue Health {The Modified Plaque Index (mPI)}.
Peri implant soft tissue health assessed using the Modified Plaque Index (mPI). Dental plaque accumulation was assessed using the modified plaque index. Clinical measurements were performed using a standardized periodontal probe with a 0.5-mm diameter tip. The presence and amount of plaque were determined at 4 sites per implant (in the middle of the four surfaces: buccal, lingual, mesial, and distal) and scored from 0 to 3.
SCORE 0: No plaque detection. SCORE 1: film of plaque detected by probing. SCORE 2: plaque seen with the naked eye. SCORE 3: abundance of soft matter within the sulcus, gingival margin, and adjacent implant surface.
Measured: Assessments performed over an 12 month total follow up period, at the following intervals: Immediately after pick up (baseline), 3 months, 6 months, and 12 months.
Peri implant Soft Tissue Health {The Modified Sulcular Bleeding Index (mSBI)}.
Peri implant soft tissue health assessed using the Modified Sulcular Bleeding Index (mSBI).The inflammatory status of the peri-implant soft tissues was assessed using the Modified Sulcular Bleeding Index (mSBI). Clinical measurements were performed using a standardized periodontal probe with a 0.5-mm diameter tip. Bleeding response was evaluated at six sites per implant: mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual, and distolingual and scored as follows:
SCORE 0: No bleeding. SCORE 1: Isolated bleeding spots visible. SCORE 2: Blood forms a confluent red line on margin. SCORE 3: Heavy or profuse bleeding.
Measured: Assessments performed over an 12 month total follow up period, at the following intervals: Immediately after pick up (baseline), 3 months, 6 months, and 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2026
- Study start1 Oct 2024
- Primary completion30 Mar 2026
- Study completion30 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complete EdentulismStudies of the same condition, open and under way.
- 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
- Participants will be randomly assigned to one of two parallel intervention groups. Each group will receive a mandibular complete overdenture retained by a single dental implant using either an OT Equator or a Ball and Socket attachment system. The groups will be followed prospectively for 12 months and compared with respect to overdenture retention.
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Hasan, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07804823
- Sponsor's protocol ID
- AUAREC20240005-3
- Status last verified
- Aug 2026
- First submitted
- 30 Aug 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between OT-Equator Versus Ball and Socket Attachment Systems in Implant-Retained Mandibular Complete Overdentures
- ClinicalTrials.gov ID
- NCT07804823
- Acronym / sponsor ID
- AUAREC20240005-3
- Conditions
- Complete Edentulism
- Keywords
- Single Implant, Retention Force, Overdenture Retention, Ball and Socket, OT Equator, Mandibular Overdenture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 30 Mar 2026 (actual)
- Study completion
- 30 May 2026 (actual)
- First posted
- 4 Sep 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.
This study compares two different attachment systems, OT Equator and Ball and Socket, used to retain mandibular complete overdentures supported by a single dental implant. The study aims to evaluate and compare the retention of the two attachment systems over a 12-month follow-up period. The study will help determine whether one attachment system provides better and more stable retention of the overdenture over time.
Detailed description
This randomized clinical study is designed to compare two attachment systems used with single-implant-retained mandibular complete overdentures: the OT Equator and Ball and Socket attachment systems. The study will evaluate how these two attachment designs perform during routine use over a 12-month follow-up period.
Participants will receive a mandibular complete overdenture retained by a single implant placed in the mandibular anterior region. The overdenture will be connected to the implant using one of the two attachment systems under investigation. Participants will be followed regularly to assess changes in the retention of the overdenture over time.
The study is intended to provide clinical evidence regarding the performance and durability of these two commonly used attachment systems and to assist clinicians in selecting an appropriate attachment system for single-implant mandibular overdenture treatment.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of two parallel intervention groups. Each group will receive a mandibular complete overdenture retained by a single dental implant using either an OT Equator or a Ball and Socket attachment system. The groups will be followed prospectively for 12 months and compared with respect to overdenture retention.
| Arm | Type | Receives |
|---|---|---|
| OT Equator Group | Experimental | Device: OT Equator Attachment SystemParticipants will receive a mandibular complete overdenture retained by a single dental implant using an OT Equator attachment system. |
| Ball and Socket Group | Experimental | Device: Ball and Socket Attachment SystemParticipants will receive a mandibular complete overdenture retained by a single dental implant using a Ball and Socket attachment system. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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 |
|---|---|---|
| OT Equator Attachment SystemA single-implant-retained mandibular complete overdenture using an OT Equator attachment system for retention. | Device | OT Equator Group |
| Ball and Socket Attachment SystemA single-implant-retained mandibular complete overdenture using a Ball and Socket attachment system for retention. | Device | Ball and Socket Group |
Primary outcome
Retention Force of Implant Overdentures (IODs)
Time frame: Time Frame: Baseline (immediately after overdenture pick-up), 3 months, 6 months, and 12 months.
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)
Peri implant Soft Tissue Health (Peri Implant Probing Depth )
Time frame: Assessments performed over an 12 month total follow up period, at the following intervals: Immediately after pick up (baseline), 3 months, 6 months, and 12 months.
Peri implant soft tissue health assessed using the Peri Implant Probing Depth (PIPD). Peri-implant probing depth (PIPD) is defined as the distance from the peri-implant mucosal margin to the base of the sulcus. Clinical measurements were performed using a standardized periodontal probe with a 0.5-mm diameter tip.
Crestal bone level changes
Time frame: Radiographic measurements performed over an 12 month total follow up period, at the following intervals: 1 - Immediately after pick up (baseline) 2 - 3 months 3 - 6 months 4 - 12 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
Peri implant Soft Tissue Health {The Modified Plaque Index (mPI)}.
Time frame: Assessments performed over an 12 month total follow up period, at the following intervals: Immediately after pick up (baseline), 3 months, 6 months, and 12 months.
Peri implant soft tissue health assessed using the Modified Plaque Index (mPI). Dental plaque accumulation was assessed using the modified plaque index. Clinical measurements were performed using a standardized periodontal probe with a 0.5-mm diameter tip. The presence and amount of plaque were determined at 4 sites per implant (in the middle of the four surfaces: buccal, lingual, mesial, and distal) and scored from 0 to 3. SCORE 0: No plaque detection. SCORE 1: film of plaque detected by probing. SCORE 2: plaque seen with the naked eye. SCORE 3: abundance of soft matter within the sulcus, gingival margin, and adjacent implant surface.
Peri implant Soft Tissue Health {The Modified Sulcular Bleeding Index (mSBI)}.
Time frame: Assessments performed over an 12 month total follow up period, at the following intervals: Immediately after pick up (baseline), 3 months, 6 months, and 12 months.
Peri implant soft tissue health assessed using the Modified Sulcular Bleeding Index (mSBI).The inflammatory status of the peri-implant soft tissues was assessed using the Modified Sulcular Bleeding Index (mSBI). Clinical measurements were performed using a standardized periodontal probe with a 0.5-mm diameter tip. Bleeding response was evaluated at six sites per implant: mesiobuccal, midbuccal, distobuccal, mesiolingual, midlingual, and distolingual and scored as follows: SCORE 0: No bleeding. SCORE 1: Isolated bleeding spots visible. SCORE 2: Blood forms a confluent red line on margin. SCORE 3: Heavy or profuse bleeding.
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 4 Sep 2026.
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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.
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 OT Equator Attachment System and Ball and Socket Attachment System in people with 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 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: finished, as of the sponsor's last update on 4 Sep 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?
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?
Retention Force of Implant Overdentures (IODs) (time frame: Time Frame: Baseline (immediately after overdenture pick-up), 3 months, 6 months, and 12 months.). The study lists 5 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 Sep 2026.