Oral Health Impact Profile Short Version 14 (OHIP 14)NCT07046104
Implant Retained Overdenture VERSUS Implant Canine Retained Overdenture.
A study testing implant retained overdenture prosthesis and implant canine retained overdenture 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 Background: mandibular class 1 modification 1 RPD can be retained by mesially placed implant only, or canines can be used to share in retention using telescopic attachment. 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 overdenture prosthesis and implant canine retained overdenture prosthesis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Jan 2023to 7 Aug 2024
- 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 Implant Retained Overdenture VERSUS Implant Canine Retained Overdenture. Crossover Clinical Study.
ABSTRACT Background: mandibular class 1 modification 1 RPD can be retained by mesially placed implant only, or canines can be used to share in retention using telescopic attachment. So, the aim of this clinical study is to evaluate patient satisfaction and oral health impact profile (OHIP-14) for implant retained Overdenture versus implant-tooth retained Overdenture.
Methods: This clinical cross-over study included 10 partially edentulous patients with only remaining mandibular canines. Every patient received two mandibular implants at the 1st premolar region. Two mandibular implant retained overdenture will be constructed, opposing a maxillary single denture. One of the dentures was made with a design based on implant retention only but the other denture was made with dual implant-tooth retention design. The effects of each overdenture design were evaluated after 3 months. patients indicated satisfaction with their prosthesis using a visual analog scale (VAS)Regarding VAS, participants were 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). The questions cover several items related to overdentures such as retention, stability, comfort, ease of cleaning, ease of speaking, ease of chewing, limited activities due to embarrassment, quality of bolus, and appearance. , and oral health impact profile (OHIP-14) was recorded for both prostheses. The Wilcoxon signed-rank test was done to compare the statistically significant difference between the two groups. SPSS ver.23. P <.05 was considered significant.
- Being tested
- implant retained overdenture prosthesis, implant canine retained overdenture prosthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
implant retained overdenture prosthesisOther
implant retained only prosthesis
implant canine retained overdenture prosthesisOther
prosthesis retention from implant and canine
| Study group | Role | What they receive |
|---|---|---|
| implant retained group | Active comparator | two implants in molar position and two remaining canines Receives: Other: implant retained overdenture prosthesis |
| implant tooth retained group | Active comparator | implant in molar position and two remaining canines Receives: Other: implant canine retained overdenture 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)
Measured: 3 months
Secondary outcomes (1)
oral health impact profile (OHIP-14) was recorded for both prostheses.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study start12 Jan 2023
- Primary completion7 Jul 2024
- Study completion7 Aug 2024
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.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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
- NCT07046104
- Sponsor's protocol ID
- A0103024RP
- Status last verified
- Jan 2023
- First submitted
- 10 Jan 2025
- Last updated
- 1 Jul 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 1 Jul 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 Implant Retained Overdenture VERSUS Implant Canine Retained Overdenture. Crossover Clinical Study.
- ClinicalTrials.gov ID
- NCT07046104
- Acronym / sponsor ID
- A0103024RP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 12 Jan 2023 (actual)
- Primary completion
- 7 Jul 2024 (actual)
- Study completion
- 7 Aug 2024 (actual)
- First posted
- 1 Jul 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 Background: mandibular class 1 modification 1 RPD can be retained by mesially placed implant only, or canines can be used to share in retention using telescopic attachment. So, the aim of this clinical study is to evaluate patient satisfaction and oral health impact profile (OHIP-14) for implant retained Overdenture versus implant-tooth retained Overdenture.
Methods: This clinical cross-over study included 10 partially edentulous patients with only remaining mandibular canines. Every patient received two mandibular implants at the 1st premolar region. Two mandibular implant retained overdenture will be constructed, opposing a maxillary single denture. One of the dentures was made with a design based on implant retention only but the other denture was made with dual implant-tooth retention design. The effects of each overdenture design were evaluated after 3 months. patients indicated satisfaction with their prosthesis using a visual analog scale (VAS)Regarding VAS, participants were 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). The questions cover several items related to overdentures such as retention, stability, comfort, ease of cleaning, ease of speaking, ease of chewing, limited activities due to embarrassment, quality of bolus, and appearance. , and oral health impact profile (OHIP-14) was recorded for both prostheses. The Wilcoxon signed-rank test was done to compare the statistically significant difference between the two groups. SPSS ver.23. P <.05 was considered significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| implant retained group | Active comparator | Other: implant retained overdenture prosthesistwo implants in molar position and two remaining canines |
| implant tooth retained group | Active comparator | Other: implant canine retained overdenture prosthesisimplant in molar position and two remaining canines |
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 overdenture prosthesisimplant retained only prosthesis | Other | implant retained group |
| implant canine retained overdenture prosthesisprosthesis retention from implant and canine | Other | implant tooth retained group |
Primary outcome
patients indicated satisfaction with their prosthesis using a visual analog scale (VAS)
Time frame: 3 months
1 secondary outcome
oral health impact profile (OHIP-14) was recorded for both prostheses.
Time frame: 3 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 1 Jul 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 overdenture prosthesis and implant canine retained overdenture 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 1 Jul 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: 3 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 1 Jul 2025.