Single-implant Versus Two-implant Mandibular Overdentures
ConditionEdentulism
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorRola Shadid
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Single-implant mandibular overdenture (parasymphyseal/canine region)
Procedure/SurgeryPlacement 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.
Two-implant mandibular overdenture (interforaminal)
Procedure/SurgeryPlacement 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.
Treatment groups
32 Participants
are divided into 2 treatment groupsGroup A: Single-implant mandibular overdenture (parasymphyseal/canine, preferred chewing side)Experimental treatment 1 intervention
Group B: Two-implant mandibular overdenture (interforaminal)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 insertion2
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.3
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.Secondary outcomes
1
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.2
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).3
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 insertion4
Implant survival
Presence of implant in situ without removal.
Time frame
Up to 12 months after overdenture insertion.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Rola Shadid
Lead sponsor
Arab American University (Palestine)
Sponsor institution
Source ClinicalTrials.gov