RecruitingNot Applicable

Single-implant Versus Two-implant Mandibular Overdentures

Palestinian Territories32 participantsStarted 2026-02-16

Plain-language summary

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.

Who can participate

Age range40 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion 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 randomized and attend follow-ups; written informed consent. * Primary stability target ≥25 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 ora…

What they're measuring

Change from baseline in Oral Health Impact Profile for Edentulous Adults (OHIP-EDENT) total score

Timeframe: Baseline (pre-surgery), 3 months after overdenture insertion, 6 months after overdenture insertion, and 12 months after overdenture insertion

Change from baseline in McGill Denture Satisfaction Questionnaire (MDSQ) total score

Timeframe: Baseline (pre-surgery), 3 months after overdenture insertion, 6 months after overdenture insertion, and 12 months after overdenture insertion.

Change from baseline in masticatory performance measured by two-color chewing gum mixing test (Variance of Hue [VoH])

Timeframe: Baseline (pre-surgery), 3 months after overdenture insertion, 6 months after overdenture insertion, and 12 months after overdenture insertion.

Trial details

NCT IDNCT07408778

SponsorRola Shadid

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-07

Contact for this trial

Rola M Shadid, BDS, MSc

+970594494066 rola.shadid@aaup.edu

View on ClinicalTrials.gov More Edentulism trials

Plain-language summary

Who can participate

Age range40 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change from baseline in Oral Health Impact Profile for Edentulous Adults (OHIP-EDENT) total score

Timeframe: Baseline (pre-surgery), 3 months after overdenture insertion, 6 months after overdenture insertion, and 12 months after overdenture insertion

Change from baseline in McGill Denture Satisfaction Questionnaire (MDSQ) total score

Timeframe: Baseline (pre-surgery), 3 months after overdenture insertion, 6 months after overdenture insertion, and 12 months after overdenture insertion.

Change from baseline in masticatory performance measured by two-color chewing gum mixing test (Variance of Hue [VoH])

Timeframe: Baseline (pre-surgery), 3 months after overdenture insertion, 6 months after overdenture insertion, and 12 months after overdenture insertion.