Evaluation of Microbial Colonization Around Implants and Overdenture Surfaces Using MK1 and Clip Attachments
Conditions
Brief 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. 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.
Interventions
DEVICEMK1 Attachment System
Double-structure bar implant-supported mandibular overdenture retained by MK1 attachments.
DEVICEBar-Clip Attachment System
Double-structure bar implant-supported mandibular overdenture retained by conventional clip attachments.
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Microbial Colonization | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of Microbial Growth Between Attachment Systems | Baseline (T0), 3 weeks (T1), 6 weeks (T2), and 9 weeks (T3). | Comparison of bacterial counts associated with double-structure bar overdentures retained by MK1 attachments versus conventional clip attachments. |
Countries
Egypt
Contacts
CONTACTMohammed Hussein Raafat abd elfatah
Outcome results
None listed