Faculty of Dentistry/ Arab American University
Jenin, Palestine, 240 jenin, Palestinian Territories
Location status: Recruiting
NCT Number: NCT07408778
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.
Interested in participating?
Request Info40 year and older
All sexes
Interventional
Not applicable
Jenin, Palestine, 240 jenin, Palestinian Territories
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Placement of one endosseous implant in the mandibular parasymphyseal/canine region on the participant's preferred chewing side, followed by delivery of a mandibular overdenture retained with a standardized attachment protocol and follow-up schedule.
Placement of two endosseous implants in the mandibular interforaminal region (bilateral lateral incisor-canine area), followed by delivery of a mandibular overdenture retained with the same standardized attachment protocol and follow-up schedule.
Time frame: Baseline (pre-surgery), 3 months after overdenture insertion, 6 months after overdenture insertion, and 12 months after overdenture insertion
Oral health-related quality of life (OHRQoL) will be assessed using the Oral Health Impact Profile for edentulous adults (OHIP-EDENT). OHIP-EDENT includes 19 items across 7 domains: functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability, and handicap. Each item is rated on a 5-point Likert scale from 0 ("never") to 4 ("very often"). Total score range is 0-76; lower scores indicate better oral health-related quality of life (OHRQoL).
Time frame: Baseline (pre-surgery), 3 months after overdenture insertion, 6 months after overdenture insertion, and 12 months after overdenture insertion.
McGill Denture Satisfaction Questionnaire (MDSQ) includes 8 core questions. Each item is scored on a 100-mm VAS (0 = "no satisfaction at all"; 100 = "complete satisfaction"). Total score = sum of 8 items (range 0-800); higher scores indicate greater satisfaction.
Time frame: Baseline (pre-surgery), 3 months after overdenture insertion, 6 months after overdenture insertion, and 12 months after overdenture insertion.
Masticatory performance will be assessed using the two-color chewing gum mixing test. Chewed specimens are imaged and analyzed using ViewGum® software to calculate the Variance of Hue (VoH; range 0-1). Lower VoH indicates better color mixing (better masticatory performance).
Time frame: 24 hours after implant surgery, 7 days after implant surgery, and 21 days after implant surgery.
Postoperative pain/discomfort will be measured using a Visual Analog Scale (VAS). The VAS has an intensity range from 0 to 100, where 0 indicates "no pain" and 100 indicates "worst pain." Higher VAS scores indicate worse outcome (greater postoperative pain/discomfort).
Time frame: Baseline (pre-surgery, expected burden); within 7 days after implant surgery (experienced surgical-stage burden); at overdenture insertion (experienced prosthodontic-stage burden).
Patient-reported treatment burden will be assessed using the Expected and Perceived Treatment Burden Questionnaire (20 items rated on a 4-point Likert scale: 1 = not burdensome at all to 4 = extremely burdensome); overall and stage-specific burden scores will be calculated as the mean item score (range 1-4), where higher scores indicate greater burden (worse outcome), and an expectation-perception discrepancy will be calculated for each stage as perceived burden - expected burden (positive values indicate greater burden than expected).
Time frame: Overdenture insertion (baseline), 3 months after overdenture insertion, and 12 months after overdenture insertion
Marginal bone level (MBL) will be measured on standardized periapical radiographs as the vertical distance (mm) from the implant platform to the first bone-to-implant contact at the mesial and distal aspects; for each implant and timepoint, mean MBL will be calculated as the average of mesial and distal measurements, and mean MBL change (mm) will be computed as the follow-up mean MBL minus the baseline mean MBL.
Time frame: Up to 12 months after overdenture insertion.
Presence of implant in situ without removal.
Time frame: Baseline (at overdenture insertion), 3 months after overdenture insertion, 12 months after overdenture insertion.
PPD will be measured at 4 sites/implant (mesial, distal, buccal, lingual) with a periodontal probe as the distance (mm) from the peri-implant mucosal margin to the base of the peri-implant sulcus; the implant-level outcome will be the mean of the four site measurements at each timepoint.
Time frame: 3 months and 12 months after overdenture insertion.
Peri-implant plaque will be assessed at 4 sites/implant (mesial, distal, buccal, lingual) using a periodontal probe by visual inspection along abutment surfaces and scored using the Mombelli modified plaque index (0-3): 0 = no plaque; 1 = plaque detected on probing; 2 = plaque visible to the naked eye; 3 = abundance of soft matter; the implant-level outcome will be the mean of the four site scores per implant at each timepoint.
Time frame: Baseline (at overdenture insertion), 3 months after overdenture insertion, 12 months after overdenture insertion.
BOP will be recorded at 4 sites/implant (mesial, distal, buccal, lingual) as present/absent after gentle probing; the implant-level outcome is the percentage of bleeding sites per implant (0-100%) at each timepoint.
Time frame: Up to 12 months after overdenture insertion.
Number and type of prosthetic maintenance events and complications related to the mandibular implant-retained overdenture recorded from clinical charts through 12 months after overdenture insertion. Events will be summarized as (a) total number of events per participant and (b) number of participants with ≥1 event. Higher values indicate worse outcome (greater maintenance/complication burden).
Time frame: From implant surgery through overdenture insertion.
Total clinician chair time (minutes) for surgical and prosthodontic procedures required to deliver the implant-retained mandibular overdenture. Lower values indicate greater treatment efficiency.
Contact information is provided by the study sponsor or research team.
Jafar AbuAssba, BDS, MSc
CONTACT
Rola M Shadid, BDS, MSc
CONTACT
Rola Shadid
Other
Patient-reported Outcomes and Masticatory Performance of Mandibular Overdentures Retained by One Parasymphyseal Implant or Two Implants: Randomized Clinical Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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