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Patient-reported Outcomes and Masticatory Performance of Mandibular Overdentures Retained by One Parasymphyseal Implant or Two Implants: Randomized Clinical 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.
Eligible completely edentulous adults will be randomized to receive either one endosseous implant in the mandibular parasymphyseal or canine region on the preferred chewing side or two endosseous implants in the mandibular interforaminal region, followed by restoration with a locator-type attachment retained mandibular overdenture. Oral health-related quality of life, patient satisfaction, and masticatory performance assessed by a two-color chewing gum mixing test are collected at baseline before surgery and at 3, 6, and 12 months after overdenture insertion. Secondary outcomes include postoperative pain recorded during the early postoperative period, radiographic marginal bone level change, peri-implant clinical parameters, prosthetic maintenance events, and clinician chair time from implant surgery through overdenture insertion.
Age
40 - No limit years
Sex
ALL
Healthy Volunteers
No
Faculty of Dentistry/ Arab American University
Jenin, Palestine, Palestinian Territories
Start Date
February 16, 2026
Primary Completion Date
July 1, 2026
Completion Date
July 1, 2027
Last Updated
February 17, 2026
32
ESTIMATED participants
Single-implant mandibular overdenture (parasymphyseal/canine region)
PROCEDURE
Two-implant mandibular overdenture (interforaminal)
PROCEDURE
Lead Sponsor
Rola Shadid
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07315607