Bone LossNCT06166316
Effect of Implant Position on Clinical Outcomes
A study testing overdenture retained by locator attachments. in people with Bone Loss and Patient Satisfaction, run by Mansoura University at 1 site in Egypt.
Trial summary
the study aims to investigate the clinical influence of different implant locations; lateral incisor, canine, and first premolar areas; supporting 2-implant retained mandibular over-dentures with locator attachment on prosthesis retention and peri-implant health. Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Bone Loss, Patient Satisfaction
- What is being tested?
- overdenture retained by locator attachments.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jan 2020to 1 Oct 2023
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- mandibular two implants retained overdenture opposing complete edentulous maxillary arch.
- patients who attended the previous follow-up recalls with previous CBCT examination
Who cannot join
- Patients who didn't attend previous follow-up recalls.
- patients who didn't perform radiographic follow-up.
- patients who had para-functional habits.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Implant Position on Clinical Outcomes of Implant-retained Mandibular Overdenture. A 3-year Retrospective Study
the study aims to investigate the clinical influence of different implant locations; lateral incisor, canine, and first premolar areas; supporting 2-implant retained mandibular over-dentures with locator attachment on prosthesis retention and peri-implant health.
Read the detailed description
the study aims to investigate the clinical influence of different implant locations; lateral incisor, canine, and first premolar areas; supporting 2-implant retained mandibular over-dentures with locator attachment on prosthesis retention and peri-implant health.
- Thirty-six edentulous patients will be recalled from the database set of the clinic of the removable prosthodontic department, Faculty of Dentistry, Mansoura University. Patients will be recruited from previous studies, having two-implant mandibular overdentures.
- All selected patients with the following criteria: mandibular two implants retained overdenture opposing complete edentulous maxillary arch, attended the previous follow-up recalls with previous CBCT examination. Patients who didn't attend previous follow-up recalls, didn't perform radiographic follow-up, or had para-functional habits will be excluded from the study.
- The patients will be grouped based on the implant position:
Group I (12 patients): patients having mandibular two implants in lateral incisor positions.
Group II (12 patients): patients having mandibular two implants in the canine positions.
Group III (12 patients): patients having mandibular two implants in the premolar positions.
- Implant-retained overdenture construction procedures:
- Primary maxillary and mandibular impressions were made, and custom trays were fabricated using auto-polymerizing acrylic resin. The mandibular tray was fabricated with holes above the implant sites and molded with green impression compound modeling plastic.
- Definitive impressions were made with non-eugenol zinc oxide paste, and the impression copings were threaded to the implants, and polyether material was injected around the copings through the opening of the tray. Auto-polymerizing acrylic resin was used to pick up the copings with the tray. Implant analogs were screwed to the copings and the impressions was poured with stone.
- Locator abutment (Dentium, Co. Ltd., Korea) screwed in the analogs. Jaw relations were recorded, and semi-anatomical acrylic teeth eeee arranged in balanced occlusion.
- The locator housing and retentive clips were incorporated into the fitting surface of the overdentures during denture processing. Method of evaluation
- Assessment of the peri-implant soft tissue health including Plaque index, Probing depth, and bleeding index. Also, evaluation of the peri-implant bone loss was done at one, two, and three years after insertion using a CBCT, following the methodology described by Elsyad et al.
- Measurements of retention values: using the device of measuring the clinical retentive forces.
- Assessment of patient satisfaction and Oral Health-Related Quality of Life: using a visual analog scale (VAS) questionnaire.
- Conditions
- Bone Loss, Patient Satisfaction
- Being tested
- overdenture retained by locator attachments.
- Keywords
- peri-implant, retention, overdenture, patient satisfaction
- Medical subject headings
- Bone Diseases, Metabolic, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
overdenture retained by locator attachments.Device
- Implant-retained overdenture construction procedures:
- Primary maxillary and mandibular impressions were made, and custom trays were fabricated using auto-polymerizing acrylic resin.
- Definitive impressions were made with non-eugenol zinc oxide paste, and the impression copings were threaded to the implants, and polyether material was injected around the copings through the opening of the tray. Auto-polymerizing acrylic resin was used to pick up the copings with the tray. Implant analogs were screwed to the copings and the impressions was poured with stone.
- Locator abutment (Dentium, Co. Ltd., Korea) screwed in the analogs. Jaw relations were recorded, and semi-anatomical acrylic teeth eeee arranged in balanced occlusion.
- The locator housing and retentive clips were incorporated into the fitting surface of the overdentures during denture processing.
| Study group | Role | What they receive |
|---|---|---|
| lateral incisor group | Active comparator | patients having mandibular two implants in lateral incisor positions. Receives: Device: overdenture retained by locator attachments. |
| canine group | Active comparator | patients having mandibular two implants in the canine positions. Receives: Device: overdenture retained by locator attachments. |
| premolar group | Active comparator | patients having mandibular two implants in the premolar positions. Receives: Device: overdenture retained by locator attachments. |
What is being measured
The primary outcome is the main question the study is designed to answer.
peri-implant plaque
modified plaque index
Measured: 3 years
peri-implant bleeding
bleeding index
Measured: 3years
peri-implant probing depth
measurements of probing depth in mm
Measured: 3 years
overdenture retention
Measurements of retention values: using the device of measuring the clinical retentive forces
Measured: 3 years
patient satisfaction
Assessment of patient satisfaction and Oral Health-Related Quality of Life: using a visual analog scale (VAS) questionnaire
Measured: 3 years
Secondary outcomes (1)
bone loss
evaluation of the peri-implant bone loss in mm
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2023
- Study start10 Jan 2020
- Primary completion30 Jan 2023
- Study completion1 Oct 2023
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 Bone LossStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Khloud Ezzat, PhD, Principal investigator, Lecturer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06166316
- Sponsor's protocol ID
- A01011023RP
- Status last verified
- Dec 2023
- First submitted
- 3 Dec 2023
- Last updated
- 20 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Raafat MH, Mourad KE, Elsyad MA. Effect of implant position on clinical outcomes of two implant overdentures: a 3-year randomized clinical trial. BMC Oral Health. 2026 May 9;26(1):866. doi: 10.1186/s12903-026-08441-0.
PubMed 42106766
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Implant Position on Clinical Outcomes of Implant-retained Mandibular Overdenture. A 3-year Retrospective Study
- ClinicalTrials.gov ID
- NCT06166316
- Acronym / sponsor ID
- A01011023RP
- Conditions
- Bone Loss, Patient Satisfaction
- Keywords
- peri-implant, retention, overdenture, patient satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 10 Jan 2020 (actual)
- Primary completion
- 30 Jan 2023 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 12 Dec 2023 (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 study aims to investigate the clinical influence of different implant locations; lateral incisor, canine, and first premolar areas; supporting 2-implant retained mandibular over-dentures with locator attachment on prosthesis retention and peri-implant health.
Detailed description
the study aims to investigate the clinical influence of different implant locations; lateral incisor, canine, and first premolar areas; supporting 2-implant retained mandibular over-dentures with locator attachment on prosthesis retention and peri-implant health.
- Thirty-six edentulous patients will be recalled from the database set of the clinic of the removable prosthodontic department, Faculty of Dentistry, Mansoura University. Patients will be recruited from previous studies, having two-implant mandibular overdentures.
- All selected patients with the following criteria: mandibular two implants retained overdenture opposing complete edentulous maxillary arch, attended the previous follow-up recalls with previous CBCT examination. Patients who didn't attend previous follow-up recalls, didn't perform radiographic follow-up, or had para-functional habits will be excluded from the study.
- The patients will be grouped based on the implant position:
Group I (12 patients): patients having mandibular two implants in lateral incisor positions.
Group II (12 patients): patients having mandibular two implants in the canine positions.
Group III (12 patients): patients having mandibular two implants in the premolar positions.
- Implant-retained overdenture construction procedures:
- Primary maxillary and mandibular impressions were made, and custom trays were fabricated using auto-polymerizing acrylic resin. The mandibular tray was fabricated with holes above the implant sites and molded with green impression compound modeling plastic.
- Definitive impressions were made with non-eugenol zinc oxide paste, and the impression copings were threaded to the implants, and polyether material was injected around the copings through the opening of the tray. Auto-polymerizing acrylic resin was used to pick up the copings with the tray. Implant analogs were screwed to the copings and the impressions was poured with stone.
- Locator abutment (Dentium, Co. Ltd., Korea) screwed in the analogs. Jaw relations were recorded, and semi-anatomical acrylic teeth eeee arranged in balanced occlusion.
- The locator housing and retentive clips were incorporated into the fitting surface of the overdentures during denture processing. Method of evaluation
- Assessment of the peri-implant soft tissue health including Plaque index, Probing depth, and bleeding index. Also, evaluation of the peri-implant bone loss was done at one, two, and three years after insertion using a CBCT, following the methodology described by Elsyad et al.
- Measurements of retention values: using the device of measuring the clinical retentive forces.
- Assessment of patient satisfaction and Oral Health-Related Quality of Life: using a visual analog scale (VAS) questionnaire.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| lateral incisor group | Active comparator | Device: overdenture retained by locator attachments.patients having mandibular two implants in lateral incisor positions. |
| canine group | Active comparator | Device: overdenture retained by locator attachments.patients having mandibular two implants in the canine positions. |
| premolar group | Active comparator | Device: overdenture retained by locator attachments.patients having mandibular two implants in the premolar positions. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- mandibular two implants retained overdenture opposing complete edentulous maxillary arch.
- patients who attended the previous follow-up recalls with previous CBCT examination
Key exclusion criteria (3 listed)
- Patients who didn't attend previous follow-up recalls.
- patients who didn't perform radiographic follow-up.
- patients who had para-functional habits.
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 |
|---|---|---|
| overdenture retained by locator attachments.• Implant-retained overdenture construction procedures: 1. Primary maxillary and mandibular impressions were made, and custom trays were fabricated using auto-polymerizing acrylic resin. 2. Definitive impressions were made with non-eugenol zinc oxide paste, and the impression copings were threaded to the implants, and polyether material was injected around the copings through the opening of the tray. Auto-polymerizing acrylic resin was used to pick up the copings with the tray. Implant analogs were screwed to the copings and the impressions was poured with stone. 3. Locator abutment (Dentium, Co. Ltd., Korea) screwed in the analogs. Jaw relations were recorded, and semi-anatomical acrylic teeth eeee arranged in balanced occlusion. 4. The locator housing and retentive clips were incorporated into the fitting surface of the overdentures during denture processing. | Device | canine group, lateral incisor group, premolar group |
Primary outcome
peri-implant plaque
Time frame: 3 years
modified plaque index
peri-implant bleeding
Time frame: 3years
bleeding index
peri-implant probing depth
Time frame: 3 years
measurements of probing depth in mm
overdenture retention
Time frame: 3 years
Measurements of retention values: using the device of measuring the clinical retentive forces
patient satisfaction
Time frame: 3 years
Assessment of patient satisfaction and Oral Health-Related Quality of Life: using a visual analog scale (VAS) questionnaire
1 secondary outcome
bone loss
Time frame: 3 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 20 Dec 2023.
- Derived from this study: PubMed 42106766Raafat MH, Mourad KE, Elsyad MA. Effect of implant position on clinical outcomes of two implant overdentures: a 3-year randomized clinical trial. BMC Oral Health. 2026 May 9;26(1):866. doi: 10.1186/s12903-026-08441-0.
- 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.
Khloud Ezzat, PhD principal investigator
Lecturer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing overdenture retained by locator attachments. in people with Bone Loss and Patient Satisfaction, 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 2 inclusion and 3 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 20 Dec 2023. 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 plaque (time frame: 3 years). 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?
On the ClinicalTrials.gov record for NCT06166316, 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 20 Dec 2023; AzTrials last refreshed its copy on 30 Oct 2026.