Microbial Evaluation of MK1 and Clip Attachments in Implant Overdentures
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-65
SponsorMansoura University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Crossover
Treatments tested in this trial
MK1 Attachment System
DeviceDouble-structure bar implant-supported mandibular overdenture retained by MK1 attachments.
Bar-Clip Attachment System
DeviceDouble-structure bar implant-supported mandibular overdenture retained by conventional clip attachments.
Treatment groups
7 Participants
are divided into 2 treatment groupsGroup A: Double-structure bar mandibular overdenture with MK1 attachmentExperimental treatment 1 intervention
Group B: Double-structure bar mandibular overdenture with clip attachmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
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.
Time frame
Baseline (T0), 3 weeks (T1), 6 weeks (T2), and 9 weeks (T3).Sponsors and contacts
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Source ClinicalTrials.gov