BridgeMD
Compares treatment options for Edentulism
Official title Single-implant Versus Two-implant Mandibular Overdentures
ClinicalTrials.gov ID: NCT07408778
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 and older
You may be able to join if
- 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.
- Technically acceptable complete dentures in both jaws for ≥3 and ≤24 months; dissatisfaction limited to mandibular retention/stability.
You likely can't join if
- 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.
See the full eligibility criteria
- 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.
- Technically acceptable complete dentures in both jaws for ≥3 and ≤24 months; dissatisfaction limited to mandibular retention/stability.
- Adequate anterior mandibular bone for implant ≥3.5×10 mm confirmed on CBCT; no bone augmentation needed.
- Normal mucosal resilience (\~2 mm displacement).
- Implant sites healed ≥4 months since extraction.
- Willingness to be assigned by chance and attend follow-ups; written informed consent.
- Primary stability target ≥25 N-cm.
- 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 treatment 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.
The study team makes the final eligibility decision.
Where it's taking place
- Jenin, Palestine, Palestinian Territories
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jenin, Palestine, Palestinian Territories. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.