An interventional study of Single-implant mandibular overdenture (parasymphyseal/canine region) and Two-implant mandibular overdenture (interforaminal) in Edentulism, sponsored by Rola Shadid. Recruiting at 1 site in Palestinian Territories. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-02-17.
Sponsored by Rola Shadid · Not applicable, Interventional, and Treatment
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.
This is the only study on the registry with Rola Shadid as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
One bone-level implant will be placed in the mandibular parasymphyseal/canine region on the preferred chewing side using a single-stage approach. A locator-type attachment (Sonator S) will be connected according to the manufacturer's instructions, and intraoral pick-up will be performed with cold-curing resin.
Procedure: Single-implant mandibular overdenture (parasymphyseal/canine region)
Two bone-level implants will be placed bilaterally in the mandibular interforaminal region (bilateral lateral incisor-canine area) using a single-stage approach. Locator-type attachments (Sonator S) will be connected according to the manufacturer's instructions, and intraoral pick-up will be performed with cold-curing resin.
Procedure: Two-implant mandibular overdenture (interforaminal)
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.
Change from baseline in Oral Health Impact Profile for Edentulous Adults (OHIP-EDENT) total score
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
Change from baseline in McGill Denture Satisfaction Questionnaire (MDSQ) total score
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.
Change from baseline in masticatory performance measured by two-color chewing gum mixing test (Variance of Hue [VoH])
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: Baseline (pre-surgery), 3 months after overdenture insertion, 6 months after overdenture insertion, and 12 months after overdenture insertion.
Visual Analog Scale (VAS) for postoperative pain
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: 24 hours after implant surgery, 7 days after implant surgery, and 21 days after implant surgery.
Expected and Perceived Treatment Burden Questionnaire Score (overall and stage-specific)
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: Baseline (pre-surgery, expected burden); within 7 days after implant surgery (experienced surgical-stage burden); at overdenture insertion (experienced prosthodontic-stage burden).
Marginal bone level (MBL) change around implants (mm)
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: Overdenture insertion (baseline), 3 months after overdenture insertion, and 12 months after overdenture insertion
Implant survival
Presence of implant in situ without removal.
Time frame: Up to 12 months after overdenture insertion.
Peri-implant probing depth (PPD), mean per implant (mm)
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: Baseline (at overdenture insertion), 3 months after overdenture insertion, 12 months after overdenture insertion.
Modified plaque index (mPI)
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: 3 months and 12 months after overdenture insertion.
Bleeding on probing (BOP) per implant (%)
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: Baseline (at overdenture insertion), 3 months after overdenture insertion, 12 months after overdenture insertion.
Prosthetic maintenance events and complications of implant-retained overdenture
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: Up to 12 months after overdenture insertion.
Treatment efficiency: total clinician chair time
Total clinician chair time (minutes) for surgical and prosthodontic procedures required to deliver the implant-retained mandibular overdenture. Lower values indicate greater treatment efficiency.
Time frame: From implant surgery through overdenture insertion.
Plan to share: Yes — De-identified individual participant data (including data dictionary/codebook) underlying the primary and secondary outcomes will be shared.
Supporting information: Study protocol, Sap, Icf, Csr
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