EdentulismNCT07408778
Single-implant Versus Two-implant Mandibular Overdentures
A study testing Single-implant mandibular overdenture (parasymphyseal/canine region) and Two-implant mandibular overdenture (interforaminal) in people with Edentulism, run by Rola Shadid at 1 site in Palestinian Territories.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Edentulism
- What is being tested?
- Single-implant mandibular overdenture (parasymphyseal/canine region) and Two-implant mandibular overdenture (interforaminal)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 sitePalestinian Territories
- Study dates
- 16 Feb 2026to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Technically acceptable complete dentures in both jaws for ≥3 and ≤24 months; dissatisfaction limited to mandibular retention/stability.
- Adequate anterior mandibular bone for implant ≥3.5×10 mm confirmed on CBCT; no bone augmentation needed.
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- Normal mucosal resilience (~2 mm displacement).
- Implant sites healed ≥4 months since extraction.
- Willingness to be randomized and attend follow-ups; written informed consent.
- Primary stability target ≥25 N-cm.
Who cannot join
- 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).
- Heavy smoking >20 cigarettes/day.
- TMD/orofacial pain; severe bruxism; moderate/severe cognitive impairment.
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- Prior implant therapy.
- Non-adherence risk or inability to attend longitudinal visits.
- Insufficient prosthetic space for attachment housing: inter-arch vertical distance <8.5 mm at parasymphyseal/canine region.
- Concurrent participation in another interventional study.
- Erosive lichen planus or other significant oral mucosal disease; head-and-neck irradiation history.
- Mandibular pathology on CBCT (e.g., cyst, tumor).
- Ridge dimensions <6 mm width or <10 mm height at planned sites.
- Active intraoral infection.
Trial locations and contacts
1 site in 1 country.
Palestinian Territories1 site
Faculty of Dentistry/ Arab American University
Jenin, Palestine, 240 jenin
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Edentulism
- Being tested
- Single-implant mandibular overdenture (parasymphyseal/canine region), Two-implant mandibular overdenture (interforaminal)
- Keywords
- mandibular denture instability, poor denture retention, implant-retained overdenture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-implant mandibular overdenture (parasymphyseal/canine region)Procedure or surgery
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.
Two-implant mandibular overdenture (interforaminal)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Single-implant mandibular overdenture (parasymphyseal/canine, preferred chewing side) | Experimental | 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. Receives: Procedure: Single-implant mandibular overdenture (parasymphyseal/canine region) |
| Two-implant mandibular overdenture (interforaminal) | Active comparator | 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. Receives: Procedure: Two-implant mandibular overdenture (interforaminal) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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).
Measured: Baseline (pre-surgery), 3 months after overdenture insertion, 6 months after overdenture insertion, and 12 months after overdenture insertion.
Secondary outcomes (9)
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).
Measured: 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).
Measured: 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.
Measured: Overdenture insertion (baseline), 3 months after overdenture insertion, and 12 months after overdenture insertion
Implant survival
Presence of implant in situ without removal.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: From implant surgery through overdenture insertion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start16 Feb 2026
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EdentulismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rola Shadid
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rola Shadid, Arab American University (Palestine)
- Investigators
- Rola M Shadid, BDS, MSc, Principal investigator, Arab American University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07408778
- Sponsor's protocol ID
- AAUP IRB Ref: J-2025A/46/N.
- Status last verified
- Feb 2026
- First submitted
- 26 Jan 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (including data dictionary/codebook) underlying the primary and secondary outcomes will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-reported Outcomes and Masticatory Performance of Mandibular Overdentures Retained by One Parasymphyseal Implant or Two Implants: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07408778
- Acronym / sponsor ID
- AAUP IRB Ref: J-2025A/46/N.
- Conditions
- Edentulism
- Keywords
- mandibular denture instability, poor denture retention, implant-retained overdenture
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Rola ShadidUniversity, hospital or other
- Study start
- 16 Feb 2026 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 13 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single-implant mandibular overdenture (parasymphyseal/canine, preferred chewing side) | Experimental | Procedure: Single-implant mandibular overdenture (parasymphyseal/canine region)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. |
| Two-implant mandibular overdenture (interforaminal) | Active comparator | Procedure: Two-implant mandibular overdenture (interforaminal)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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
- Technically acceptable complete dentures in both jaws for ≥3 and ≤24 months; dissatisfaction limited to mandibular retention/stability.
Key exclusion criteria (14 listed)
- 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).
- Heavy smoking >20 cigarettes/day.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single-implant mandibular overdenture (parasymphyseal/canine region)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. | Procedure or surgery | Single-implant mandibular overdenture (parasymphyseal/canine, preferred chewing side) |
| Two-implant mandibular overdenture (interforaminal)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. | Procedure or surgery | Two-implant mandibular overdenture (interforaminal) |
Primary outcome
Change from baseline in Oral Health Impact Profile for Edentulous Adults (OHIP-EDENT) total score
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).
Change from baseline in McGill Denture Satisfaction Questionnaire (MDSQ) total score
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.
Change from baseline in masticatory performance measured by two-color chewing gum mixing test (Variance of Hue [VoH])
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).
9 secondary outcomes
Visual Analog Scale (VAS) for postoperative pain
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)
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)
Time frame: Overdenture insertion (baseline), 3 months after overdenture insertion, and 12 months after overdenture insertion
Implant survival
Time frame: Up to 12 months after overdenture insertion.
Peri-implant probing depth (PPD), mean per implant (mm)
Time frame: Baseline (at overdenture insertion), 3 months after overdenture insertion, 12 months after overdenture insertion.
Modified plaque index (mPI)
Time frame: 3 months and 12 months after overdenture insertion.
Bleeding on probing (BOP) per implant (%)
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
Time frame: Up to 12 months after overdenture insertion.
Treatment efficiency: total clinician chair time
Time frame: From implant surgery through overdenture insertion.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (including data dictionary/codebook) underlying the primary and secondary outcomes will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rola M Shadid, BDS, MSc principal investigator
Arab American University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single-implant mandibular overdenture (parasymphyseal/canine region) and Two-implant mandibular overdenture (interforaminal) in people with Edentulism, run by Rola Shadid at 1 site in Palestinian Territories.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Palestinian Territories. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Oral Health Impact Profile for Edentulous Adults (OHIP-EDENT) total score (time frame: Baseline (pre-surgery), 3 months after overdenture insertion, 6 months after overdenture insertion, and 12 months after overdenture insertion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.