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Single-implant Versus Two-implant Mandibular Overdentures

RecruitingNAAges 40 Years - anyAllRola Shadid
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Men and women โ‰ฅ40 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. * Technically acceptable complete dentures in both jaws for โ‰ฅ3 and โ‰ค24 months; dissatisfaction limited to mandibular retention/stability. * Adequate anterior mandibular bone for implant โ‰ฅ3.5ร—10 mm confirmed on CBCT; no bone augmentation needed. * Normal mucosal resilience (\~2 mm displacement). * Implant sites healed โ‰ฅ4 months since extraction. * Willingness to be randomized and attend follow-ups; written informed consent. * Primary stability target โ‰ฅ25 N-cm. Exclusion Criteria: * 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). * Heavy smoking \>20 cigarettes/day. * TMD/orofacial pain; severe bruxism; moderate/severe cognitive impairment. * Prior implant therapy. * Non-adherence risk or inability to attend longitudinal visits. * Insufficient prosthetic space for attachment housing: inter-arch vertical distance \<8.5 mm at parasymphyseal/canine region. * Concurrent participation in another interventional study. * Erosive lichen planus or other significant oral mucosal disease; head-and-neck irradiation history. * Mandibular pathology on CBCT (e.g., cyst, tumor). * Ridge dimensions \<6 mm width or \<10 mm height at planned sites. * Active intraoral infection.
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What it tests

  • Single-implant mandibular overdenture (parasymphyseal/canine region)
  • Two-implant mandibular overdenture (interforaminal)
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Where

1 site
Faculty of Dentistry/ Arab American University
Jenin, Palestinian Territories
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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