Actively Recruiting

Phase Not Applicable
Age: 40Years +
All Genders
NCT07408778

Single-implant Versus Two-implant Mandibular Overdentures

Led by Rola Shadid · Updated on 2026-02-17

32

Participants Needed

1

Research Sites

71 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Single-implant Versus Two-implant Mandibular Overdentures

Who Can Participate

Age: 40Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Men and women 40 years or older
  • 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 at least 3 and up to 24 months; dissatisfaction limited to mandibular retention/stability
  • Adequate anterior mandibular bone for implant 3.5x10 mm confirmed on CBCT; no bone augmentation needed
  • Normal mucosal resilience (~2 mm displacement)
  • Implant sites healed at least 4 months since extraction
  • Willingness to be randomized and attend follow-ups; written informed consent
  • Primary stability target 25 N-cm
Not Eligible

You will not qualify if you...

  • 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 or illicit drug use; xerostomia (stimulated flow <0.7 mL/min)
  • Heavy smoking more than 20 cigarettes per day
  • Temporomandibular disorder or orofacial pain; severe bruxism; moderate/severe cognitive impairment
  • Prior implant therapy
  • Risk for non-adherence or inability to attend longitudinal visits
  • Insufficient prosthetic space for attachment housing: inter-arch vertical distance less than 8.5 mm at parasymphyseal/canine region
  • Concurrent participation in another interventional study
  • Erosive lichen planus or other significant oral mucosal disease; history of head-and-neck irradiation
  • Mandibular pathology on CBCT (e.g., cyst, tumor)
  • Ridge dimensions less than 6 mm width or less than 10 mm height at planned sites
  • Active intraoral infection

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Faculty of Dentistry/ Arab American University

Jenin, Palestine, Palestinian Territories, 240 jenin

Actively Recruiting

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Research Team

R

Rola M Shadid, BDS, MSc

CONTACT

J

Jafar AbuAssba, BDS, MSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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