Marginal Bone Loss Around ImplantsNCT07536776
Radiographic and Retention Evaluation Over Seven Years for Four Implant Retained Overdenture
A study testing implant retained overdenture and four dental implant with locator attachment in people with Marginal Bone Loss Around Implants, run by Mansoura University at 1 site in Egypt.
Trial summary
ABSTRACT Statement of the problem: Insufficient long-term retrospective data is evaluating marginal bone loss and retention of four-implant Locator-retained mandibular overdentures. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Marginal Bone Loss Around Implants
- What is being tested?
- implant retained overdenture and four dental implant with locator attachment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Jan 2018to 20 Feb 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Inclusion Criteria Patients rehabilitated with a mandibular overdenture retained by four dental implants.
Four implants positioned in the anterior and premolar regions of the mandible. Four Locator attachments used to retain the mandibular overdenture. Availability of baseline clinical and radiographic records at the time of prosthesis insertion.
Availability of clinical and radiographic records at 1-year and 7-year follow-up.
Exclusion Criteria Patients with incomplete clinical or radiographic records. Patients without the required 1-year or 7-year follow-up records. Patients with radiographs that were inadequate for reliable assessment of peri-implant marginal bone levels.
Patients whose records did not allow assessment of prosthetic retention at the specified follow-up periods.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Marginal Bone Loss and Retention of Four-Implant Locator-Retained Mandibular Overdentures: 7 Years Follow up
ABSTRACT Statement of the problem: Insufficient long-term retrospective data is evaluating marginal bone loss and retention of four-implant Locator-retained mandibular overdentures.
Purpose: To assess marginal bone loss and retention of four-implant Locator-retained mandibular overdentures over seven years at the time of overdenture insertion (T0), 1 year (T1), and 7 years (T7) after insertion.
Material and methods: This retrospective study included 27 completely edentulous patients with maxillary single denture, and four parallel implants were placed interforaminal, and they already have a mandibular four-implant retained overdenture with LOCATOR attachments.
- Conditions
- Marginal Bone Loss Around Implants
- Being tested
- implant retained overdenture, four dental implant with locator attachment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
implant retained overdentureOther
4 implants retained prosthesis by locators
four dental implant with locator attachmentDevice
A mandibular overdenture retained by four dental implants using Locator attachments. The implants are positioned in the anterior and premolar regions of the mandible, and the prosthesis is retained by four Locator attachments. Patients are followed clinically and radiographically over the follow-up period.
| Study group | Role | What they receive |
|---|---|---|
| Implant-Retained Overdenture Group | Experimental | Not described Receives: Other: implant retained overdenture; Device: four dental implant with locator attachment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marginal Bone Loss by periapical radiography
Marginal bone loss will be assessed using standardized intraoral periapical radiographs. The vertical distance from the implant reference point to the alveolar bone crest will be measured on the mesial and distal surfaces of each implant. Measurements will be recorded at implant insertion (baseline), 1 year, and 7 years, and the mean value of the four implants will be calculated for each patient.
Measured: From the time of implant loading (Baseline), 1year and 7 years.
Secondary outcomes (1)
Prosthetic Retention by a digital force gauge
Prosthetic retention will be assessed by measuring the dislodging force required to remove the mandibular overdenture using a digital force gauge. The retention force will be recorded in Newtons (N) at baseline and at 7 years after insertion.
Measured: baseline, 1year and 7 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study start12 Jan 2018
- Primary completion15 Jan 2026
- Study completion20 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Marginal Bone Loss Around ImplantsStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 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
- NCT07536776
- Sponsor's protocol ID
- R.26.02.105
- Status last verified
- Aug 2026
- First submitted
- 11 Apr 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Marginal Bone Loss and Retention of Four-Implant Locator-Retained Mandibular Overdentures: 7 Years Follow up
- ClinicalTrials.gov ID
- NCT07536776
- Acronym / sponsor ID
- R.26.02.105
- Conditions
- Marginal Bone Loss Around Implants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 12 Jan 2018 (actual)
- Primary completion
- 15 Jan 2026 (actual)
- Study completion
- 20 Feb 2026 (actual)
- First posted
- 17 Apr 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.
ABSTRACT Statement of the problem: Insufficient long-term retrospective data is evaluating marginal bone loss and retention of four-implant Locator-retained mandibular overdentures.
Purpose: To assess marginal bone loss and retention of four-implant Locator-retained mandibular overdentures over seven years at the time of overdenture insertion (T0), 1 year (T1), and 7 years (T7) after insertion.
Material and methods: This retrospective study included 27 completely edentulous patients with maxillary single denture, and four parallel implants were placed interforaminal, and they already have a mandibular four-implant retained overdenture with LOCATOR attachments.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Implant-Retained Overdenture Group | Experimental | Other: implant retained overdenture, Device: four dental implant with locator attachment |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| implant retained overdenture4 implants retained prosthesis by locators | Other | Implant-Retained Overdenture Group |
| four dental implant with locator attachmentA mandibular overdenture retained by four dental implants using Locator attachments. The implants are positioned in the anterior and premolar regions of the mandible, and the prosthesis is retained by four Locator attachments. Patients are followed clinically and radiographically over the follow-up period. | Device | Implant-Retained Overdenture Group |
Primary outcome
Marginal Bone Loss by periapical radiography
Time frame: From the time of implant loading (Baseline), 1year and 7 years.
Marginal bone loss will be assessed using standardized intraoral periapical radiographs. The vertical distance from the implant reference point to the alveolar bone crest will be measured on the mesial and distal surfaces of each implant. Measurements will be recorded at implant insertion (baseline), 1 year, and 7 years, and the mean value of the four implants will be calculated for each patient.
1 secondary outcome
Prosthetic Retention by a digital force gauge
Time frame: baseline, 1year and 7 years.
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 13 Aug 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. 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 implant retained overdenture and four dental implant with locator attachment in people with Marginal Bone Loss Around Implants, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 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?
Marginal Bone Loss by periapical radiography (time frame: From the time of implant loading (Baseline), 1year and 7 years.). 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 13 Aug 2026.