Evaluation of Microbial Colonization Around Implants and Overdenture Surfaces Using MK1 and Clip AttachmentsNCT07817498
Microbial Evaluation of MK1 and Clip Attachments in Implant Overdentures
A study testing MK1 Attachment System and Bar-Clip Attachment System in people with Evaluation of Microbial Colonization Around Implants and Overdenture Surfaces Using MK1 and Clip Attachments, run by Mansoura University at 1 site in Egypt.
Trial summary
This crossover clinical trial aims to compare the microbial colonization associated with double-structure bar implant-supported mandibular overdentures retained by either MK1 or conventional clip attachments. Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Evaluation of Microbial Colonization Around Implants and Overdenture Surfaces Using MK1 and Clip Attachments
- What is being tested?
- MK1 Attachment System and Bar-Clip Attachment System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2026to 1 Jan 2027
- 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 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Completely edentulous patients aged 45-65 years.
- Medically healthy patients with no systemic conditions affecting implant placement or osseointegration.
- Healthy maxillary and mandibular residual ridges covered by firm mucosa.
- Adequate mandibular bone volume in the interforaminal region to receive four implants (minimum 4 mm diameter and 12 mm length), confirmed by CBCT.
- Class I maxillomandibular relationship with sufficient interarch space for implant-supported overdentures.
Who cannot join
- Uncontrolled diabetes mellitus, immune disorders, osteoporosis, or other contraindications to implant therapy.
- Parafunctional habits such as bruxism or clenching.
- Flabby ridges or oral mucosal diseases.
- Severe temporomandibular joint disorders.
- History of allergy to denture or implant materials.
- Previous radiotherapy to the head and neck region.
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, 1 recruiting
- Recruiting
Mansoura university faculty of dentistry
Al Mansurah, 35511
faculty of dentistry, Mansoura university, 0025022671521, dentfac@mans.edu.eg
About this study
Official title: Microbial Evaluation in Patients Wear Double Structure Bars Implant Supported Mandibular Overdentures Attached by Clips or MK-1 Attachments
This crossover clinical trial aims to compare the microbial colonization associated with double-structure bar implant-supported mandibular overdentures retained by either MK1 or conventional clip attachments. Seven completely edentulous patients will receive both attachment systems sequentially, allowing each participant to serve as their own control. Microbial samples will be collected from the intaglio surface of the prosthesis and peri-implant areas at different follow-up intervals to assess the prevalence of oral microorganisms. The findings will help determine whether the type of attachment influences microbial accumulation and may contribute to improved maintenance and long-term success of implant-supported overdentures.
- Being tested
- MK1 Attachment System, Bar-Clip Attachment System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK1 Attachment SystemDevice
Double-structure bar implant-supported mandibular overdenture retained by MK1 attachments.
Bar-Clip Attachment SystemDevice
Double-structure bar implant-supported mandibular overdenture retained by conventional clip attachments.
| Study group | Role | What they receive |
|---|---|---|
| Double-structure bar mandibular overdenture with MK1 attachment | Experimental | Double-structure bar implant-supported mandibular overdenture retained by MK1 attachments. Receives: Device: MK1 Attachment System |
| Double-structure bar mandibular overdenture with clip attachment | Experimental | Double-structure bar implant-supported mandibular overdenture retained by conventional clip attachments. Receives: Device: Bar-Clip Attachment System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbial Colonization
Quantitative assessment of streptococci and staphylococci species collected from the fitting surface of the prosthesis and peri-implant areas using blood agar culture.
Measured: Baseline (T0), 3 weeks (T1), 6 weeks (T2), and 9 weeks (T3) after prosthesis delivery.
Secondary outcomes (1)
Comparison of Microbial Growth Between Attachment Systems
Comparison of bacterial counts associated with double-structure bar overdentures retained by MK1 attachments versus conventional clip attachments.
Measured: Baseline (T0), 3 weeks (T1), 6 weeks (T2), and 9 weeks (T3).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start1 Mar 2026
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Evaluation of Microbial Colonization Around Implants and Overdenture Surfaces Using MK1 and Clip AttachmentsStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 7 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07817498
- Sponsor's protocol ID
- MS.25.12.103
- Status last verified
- Jun 2026
- First submitted
- 8 Sep 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbial Evaluation in Patients Wear Double Structure Bars Implant Supported Mandibular Overdentures Attached by Clips or MK-1 Attachments
- ClinicalTrials.gov ID
- NCT07817498
- Acronym / sponsor ID
- MS.25.12.103
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 7 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 14 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 crossover clinical trial aims to compare the microbial colonization associated with double-structure bar implant-supported mandibular overdentures retained by either MK1 or conventional clip attachments. Seven completely edentulous patients will receive both attachment systems sequentially, allowing each participant to serve as their own control. Microbial samples will be collected from the intaglio surface of the prosthesis and peri-implant areas at different follow-up intervals to assess the prevalence of oral microorganisms. The findings will help determine whether the type of attachment influences microbial accumulation and may contribute to improved maintenance and long-term success of implant-supported overdentures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Double-structure bar mandibular overdenture with MK1 attachment | Experimental | Device: MK1 Attachment SystemDouble-structure bar implant-supported mandibular overdenture retained by MK1 attachments. |
| Double-structure bar mandibular overdenture with clip attachment | Experimental | Device: Bar-Clip Attachment SystemDouble-structure bar implant-supported mandibular overdenture retained by conventional clip attachments. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Completely edentulous patients aged 45-65 years.
- Medically healthy patients with no systemic conditions affecting implant placement or osseointegration.
- Healthy maxillary and mandibular residual ridges covered by firm mucosa.
- Adequate mandibular bone volume in the interforaminal region to receive four implants (minimum 4 mm diameter and 12 mm length), confirmed by CBCT.
- Class I maxillomandibular relationship with sufficient interarch space for implant-supported overdentures.
Key exclusion criteria (6 listed)
- Uncontrolled diabetes mellitus, immune disorders, osteoporosis, or other contraindications to implant therapy.
- Parafunctional habits such as bruxism or clenching.
- Flabby ridges or oral mucosal diseases.
- Severe temporomandibular joint disorders.
- History of allergy to denture or implant materials.
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 |
|---|---|---|
| MK1 Attachment SystemDouble-structure bar implant-supported mandibular overdenture retained by MK1 attachments. | Device | Double-structure bar mandibular overdenture with MK1 attachment |
| Bar-Clip Attachment SystemDouble-structure bar implant-supported mandibular overdenture retained by conventional clip attachments. | Device | Double-structure bar mandibular overdenture with clip attachment |
Primary outcome
Microbial Colonization
Time frame: Baseline (T0), 3 weeks (T1), 6 weeks (T2), and 9 weeks (T3) after prosthesis delivery.
Quantitative assessment of streptococci and staphylococci species collected from the fitting surface of the prosthesis and peri-implant areas using blood agar culture.
1 secondary outcome
Comparison of Microbial Growth Between Attachment Systems
Time frame: Baseline (T0), 3 weeks (T1), 6 weeks (T2), and 9 weeks (T3).
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 14 Sep 2026.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MK1 Attachment System and Bar-Clip Attachment System in people with Evaluation of Microbial Colonization Around Implants and Overdenture Surfaces Using MK1 and Clip Attachments, 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 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: looking for participants now, as of the sponsor's last update on 14 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?
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 Mohammed Hussein Raafat abd elfatah (+201092663488, mohammed.hussein@mans.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbial Colonization (time frame: Baseline (T0), 3 weeks (T1), 6 weeks (T2), and 9 weeks (T3) after prosthesis delivery.). 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 14 Sep 2026.