Single-implant Versus Two-implant Mandibular Overdentures
ConditionEdentulism
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorRola Shadid
About this trial
This randomized controlled trial compares a mandibular overdenture retained by one implant placed in the parasymphyseal or canine region with a mandibular overdenture retained by two implants placed in the interforaminal region in completely edentulous adults. Primary outcomes are oral health-related quality of life, patient satisfaction, and masticatory performance measured by a two-color chewing gum mixing test, assessed at baseline before implant surgery and at 3, 6, and 12 months after overdenture insertion.
Eligibility criteria
Qualifiers
Men and women ≥40 years.
ASA I-II; favorable general health or adequately controlled systemic disease (e.g., hypertension, diabetes).
Skeletal Class I relationship.
Completely edentulous mandible and maxilla.
Disqualifiers
Uncontrolled systemic disease; neurodegenerative disease; osteoporosis requiring antiresorptives.
Chronic systemic antibiotics/steroids; bleeding disorders; active cancer therapy; metabolic bone disease; HIV.
Investigational drug use within 30 days.
Alcohol dependence/illicit drug use; xerostomia (stimulated flow <0.7 mL/min).
Trial design
Treatments tested in this trial
- Single-implant mandibular overdenture (parasymphyseal/canine region)
- Two-implant mandibular overdenture (interforaminal)
Treatment groups
32 Participants
are divided into 2 treatment groupsSponsors and collaborators
Rola Shadid
Lead sponsor
Arab American University (Palestine)
Sponsor institution
Source ClinicalTrials.gov