Oral Health Impact Profile Short Version 14 (OHIP 14)NCT07144787
Four Implant Retained Mandibular Overdenture VERSUS Fixed-detachable Prosthesis.
A study testing implant retained complete Overdenture and Fixed-detachable prosthesis in people with Oral Health Impact Profile Short Version 14 (OHIP 14), run by Mansoura University at 1 site in Egypt.
Trial summary
ABSTRACT Statement of the problem: completely edentulous patient can be treated by four implants for implant retained overdenture or fixed detachable prosthesis. Purpose: the purpose of this clinical study is to evaluate patient satisfaction and oral health impact profile (OHIP-14) for four implant retained complete… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Oral Health Impact Profile Short Version 14 (OHIP 14)
- What is being tested?
- implant retained complete Overdenture and Fixed-detachable prosthesis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2024to 12 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- This research will be done on patients who were previously received 2 mesially placed implants in the 1st premolar region with only two remaining mandibular canines with opposing maxillary single denture
Who cannot join
- uncontrolled diabetic patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patient Satisfaction and Oral Health Related Quality of Life for Four Implant Retained Mandibular Overdenture VERSUS Fixed-detachable Prosthesis. Crossover Clinical Study
ABSTRACT Statement of the problem: completely edentulous patient can be treated by four implants for implant retained overdenture or fixed detachable prosthesis.
Purpose: the purpose of this clinical study is to evaluate patient satisfaction and oral health impact profile (OHIP-14) for four implant retained complete Overdenture versus Fixed-detachable prosthesis.
Material and methods: This clinical cross-over study included 10 completely edentulous patients with maxillary single denture and four parallel implants were placed intraforminal. Every patient received two mandibular implants at the 1st premolar region and two mandibular implants in lateral incisor region. Ten completely edentulous patients received implant retained overdenture for six months (Group I), then fixed detachable prostheses on four implants for the following six months (Group II). For both designs, patient satisfaction using visual analogue scale (VAS) and oral health impact profile (OHIP-14) will be recorded for both prostheses. SPSS program will be used for statistical analysis.
- Being tested
- implant retained complete Overdenture, Fixed-detachable prosthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
implant retained complete OverdentureOther
four implant retained complete Overdenture versus Fixed-detachable prosthesis
Fixed-detachable prosthesisOther
four implant retained complete Overdenture versus Fixed-detachable prosthesis.
| Study group | Role | What they receive |
|---|---|---|
| implant retained complete Overdenture | Active comparator | implant retained complete Overdenture Receives: Other: implant retained complete Overdenture |
| Fixed-detachable prosthesis. | Active comparator | Fixed-detachable prosthesis. Receives: Other: Fixed-detachable prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
patients indicated satisfaction with their prosthesis using a visual analog scale (VAS)
participants will be asked to score their answer according to the amount of satisfaction on a 100 mm line (Score 0 = no satisfaction at all and score 100 = complete satisfaction).
Measured: 6 months
Secondary outcomes (1)
oral health impact profile (OHIP-14) was recorded for both prostheses.
Regarding the oral health-related quality of life (OHRQoL), oral health impact profile (OHIP-14), the questions covered seven domains: functional limitation, physical pain, physical disability, psychologic discomfort, psychologic disability, social disability, and handicap. Also, these questions will be translated into Arabic by linguistic professionals who act in collaboration with the authors to prepare the final version. The translation will be made using a forward-backward approach. The answers of the questionnaire include score 1 = never, score 2 = hardly ever, score 3 = occasionally, score 4 = fairly often, and score 5 = very often.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study start1 May 2024
- Primary completion1 Aug 2024
- Study completion12 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Health Impact Profile Short Version 14 (OHIP 14)Studies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07144787
- Sponsor's protocol ID
- A02010024RP
- Status last verified
- Aug 2025
- First submitted
- 25 Aug 2025
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Satisfaction and Oral Health Related Quality of Life for Four Implant Retained Mandibular Overdenture VERSUS Fixed-detachable Prosthesis. Crossover Clinical Study
- ClinicalTrials.gov ID
- NCT07144787
- Acronym / sponsor ID
- A02010024RP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 12 Jan 2025 (actual)
- First posted
- 28 Aug 2025 (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.
ABSTRACT Statement of the problem: completely edentulous patient can be treated by four implants for implant retained overdenture or fixed detachable prosthesis.
Purpose: the purpose of this clinical study is to evaluate patient satisfaction and oral health impact profile (OHIP-14) for four implant retained complete Overdenture versus Fixed-detachable prosthesis.
Material and methods: This clinical cross-over study included 10 completely edentulous patients with maxillary single denture and four parallel implants were placed intraforminal. Every patient received two mandibular implants at the 1st premolar region and two mandibular implants in lateral incisor region. Ten completely edentulous patients received implant retained overdenture for six months (Group I), then fixed detachable prostheses on four implants for the following six months (Group II). For both designs, patient satisfaction using visual analogue scale (VAS) and oral health impact profile (OHIP-14) will be recorded for both prostheses. SPSS program will be used for statistical analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| implant retained complete Overdenture | Active comparator | Other: implant retained complete Overdentureimplant retained complete Overdenture |
| Fixed-detachable prosthesis. | Active comparator | Other: Fixed-detachable prosthesisFixed-detachable prosthesis. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- This research will be done on patients who were previously received 2 mesially placed implants in the 1st premolar region with only two remaining mandibular canines with opposing maxillary single denture
Key exclusion criteria (1 listed)
- uncontrolled diabetic patients
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 |
|---|---|---|
| implant retained complete Overdenturefour implant retained complete Overdenture versus Fixed-detachable prosthesis | Other | implant retained complete Overdenture |
| Fixed-detachable prosthesisfour implant retained complete Overdenture versus Fixed-detachable prosthesis. | Other | Fixed-detachable prosthesis. |
Primary outcome
patients indicated satisfaction with their prosthesis using a visual analog scale (VAS)
Time frame: 6 months
participants will be asked to score their answer according to the amount of satisfaction on a 100 mm line (Score 0 = no satisfaction at all and score 100 = complete satisfaction).
1 secondary outcome
oral health impact profile (OHIP-14) was recorded for both prostheses.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing implant retained complete Overdenture and Fixed-detachable prosthesis in people with Oral Health Impact Profile Short Version 14 (OHIP 14), run by Mansoura University at 1 site in Egypt.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 24 Dec 2025. 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
patients indicated satisfaction with their prosthesis using a visual analog scale (VAS) (time frame: 6 months). 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 24 Dec 2025.