Edentulous JawNCT05675566
Time-dependent Change in the Retention Force of the Implant Overdenture
An observational study of Edentulous Jaw, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
This descriptive longitudinal study aimed to investigate the retention force of implant-supported overdentures applied to edentulous individuals at Marmara University Faculty of Dentistry, examine the retention force and its time-dependent change, and evaluate patient satisfaction. Read more about this study
- Who is it for?
- Ages 50 to 65 years
- Conditions the study is for
- Edentulous Jaw
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2023to 1 Feb 2024
- Phase
- Observational
- 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 50 to 65 years
- All sexes
- Adult, Older adult
Study population: Our study will include individuals who have been rehabilitated with implant overdentures at Marmara University Faculty of Dentistry, Department of Prosthodontics.
Who may be able to join
- 50-65 years old,
- Volunteer to participate in the study,
- Upper edentulous jaw with full denture, lower edentulous jaw with two-implant overdenture
Who cannot join
- Pregnant or lactating women
- Those who do not want to sign the consent form,
- Patients with a history of malignancy, radiotherapy, or chemotherapy
- Patients whose maxilla was rehabilitated with implant overdenture
- More than 2 implants for lower jaw implant overdenture
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara University School of Dentistry
Istanbul, 34854
About this study
Official title: Investigation of Time-Dependent Change of Retention Force of Mandibular Implant Overdenture and Evaluation of Patient Satisfaction: A Clinical Follow-up Study
This descriptive longitudinal study aimed to investigate the retention force of implant-supported overdentures applied to edentulous individuals at Marmara University Faculty of Dentistry, examine the retention force and its time-dependent change, and evaluate patient satisfaction.
- Conditions
- Edentulous Jaw
- Keywords
- Dental Prosthesis, Implant-Supported
- Medical subject headings
- Jaw, Edentulous
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in retention force
The retention of a complete implant overdenture prosthesis is defined as the minimum retention force (N) required to separate the male part of the attachment from the female part. The retention strength will be measured 3 times with a force gauge that allows the application of the retention force perpendicular to the occlusal plane of the prosthesis and parallel to the long axis of the implant, and the values will be averaged with a digital dynamometer. As the measurement value increases, it is concluded that the retention of the prosthesis increases. The measurements will be recorded on the 'Patient Measurement Card' at each control session.
The retention of the implanted complete denture will be measured at the time of delivery of the implant overdenture to the patient and at the control sessions 1 week, 1 month, 3 months, and 6 months after the patient start to use the denture.
Measured: 6 months
Secondary outcomes (1)
Change in patient satisfaction
Patients' overall satisfaction, comfort, speech ability, prosthesis stability, retention, aesthetics, and ease of cleaning will be assessed using VAS measurements. The rating words will be 'very satisfied' and 'not at all satisfied,' and patients will be asked to draw a vertical line on a 10 cm horizontal line at the point that best represents their perception. The VAS total score is between 0-10. As the score increases, it is concluded that the patient's satisfaction increases. Patients will be asked to fill out the VAS questionnaire form during the 1st month (TI) after using the prosthesis and at 3 months and 6 months of control sessions.
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 posted9 Jan 2023
- Study start1 Feb 2023
- Primary completion1 Nov 2023
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Edentulous JawStudies of the same condition, open and under way.
- More trials run by Marmara 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ferit Bayram, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05675566
- Sponsor's protocol ID
- MUDHF_PTT_01
- Status last verified
- Mar 2024
- First submitted
- 22 Dec 2022
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Akoglu B, Ucankale M, Ozkan Y, Kulak-Ozkan Y. Five-year treatment outcomes with three brands of implants supporting mandibular overdentures. Int J Oral Maxillofac Implants. 2011 Jan-Feb;26(1):188-94.
PubMed 21365055Cousson PY, Bessadet M, Nicolas E, Veyrune JL, Lesourd B, Lassauzay C. Nutritional status, dietary intake and oral quality of life in elderly complete denture wearers. Gerodontology. 2012 Jun;29(2):e685-92. doi: 10.1111/j.1741-2358.2011.00545.x. Epub 2011 Oct 17.
PubMed 22004061Evtimovska E, Masri R, Driscoll CF, Romberg E. The change in retentive values of locator attachments and hader clips over time. J Prosthodont. 2009 Aug;18(6):479-83. doi: 10.1111/j.1532-849X.2009.00474.x. Epub 2009 Jun 3.
PubMed 19500236Fromentin O, Lassauzay C, Abi Nader S, Feine J, de Albuquerque Junior RF. Testing the retention of attachments for implant overdentures - validation of an original force measurement system. J Oral Rehabil. 2010 Jan;37(1):54-62. doi: 10.1111/j.1365-2842.2009.02020.x. Epub 2009 Nov 11.
PubMed 19912482Sultana N, Bartlett DW, Suleiman M. Retention of implant-supported overdentures at different implant angulations: comparing Locator and ball attachments. Clin Oral Implants Res. 2017 Nov;28(11):1406-1410. doi: 10.1111/clr.13003. Epub 2017 Feb 13.
PubMed 28191678Ucankale M, Akoglu B, Ozkan Y, Ozkan YK. The effect of different attachment systems with implant-retained overdentures on maximum bite force and EMG. Gerodontology. 2012 Mar;29(1):24-9. doi: 10.1111/j.1741-2358.2010.00389.x. Epub 2010 Jun 30.
PubMed 20604812Uludag B, Polat S, Sahin V, Comut AA. Effects of implant angulations and attachment configurations on the retentive forces of locator attachment-retained overdentures. Int J Oral Maxillofac Implants. 2014 Sep-Oct;29(5):1053-7. doi: 10.11607/jomi.3401.
PubMed 25216129
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Time-Dependent Change of Retention Force of Mandibular Implant Overdenture and Evaluation of Patient Satisfaction: A Clinical Follow-up Study
- ClinicalTrials.gov ID
- NCT05675566
- Acronym / sponsor ID
- MUDHF_PTT_01
- Conditions
- Edentulous Jaw
- Keywords
- Dental Prosthesis, Implant-Supported
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 9 Jan 2023 (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 descriptive longitudinal study aimed to investigate the retention force of implant-supported overdentures applied to edentulous individuals at Marmara University Faculty of Dentistry, examine the retention force and its time-dependent change, and evaluate patient satisfaction.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Our study will include individuals who have been rehabilitated with implant overdentures at Marmara University Faculty of Dentistry, Department of Prosthodontics.
Key inclusion criteria (3 listed)
- 50-65 years old,
- Volunteer to participate in the study,
- Upper edentulous jaw with full denture, lower edentulous jaw with two-implant overdenture
Key exclusion criteria (5 listed)
- Pregnant or lactating women
- Those who do not want to sign the consent form,
- Patients with a history of malignancy, radiotherapy, or chemotherapy
- Patients whose maxilla was rehabilitated with implant overdenture
- More than 2 implants for lower jaw implant overdenture
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in retention force
Time frame: 6 months
The retention of a complete implant overdenture prosthesis is defined as the minimum retention force (N) required to separate the male part of the attachment from the female part. The retention strength will be measured 3 times with a force gauge that allows the application of the retention force perpendicular to the occlusal plane of the prosthesis and parallel to the long axis of the implant, and the values will be averaged with a digital dynamometer. As the measurement value increases, it is concluded that the retention of the prosthesis increases. The measurements will be recorded on the 'Patient Measurement Card' at each control session. The retention of the implanted complete denture will be measured at the time of delivery of the implant overdenture to the patient and at the control sessions 1 week, 1 month, 3 months, and 6 months after the patient start to use the denture.
1 secondary outcome
Change in patient satisfaction
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 12 Mar 2024.
- Background: PubMed 21365055Akoglu B, Ucankale M, Ozkan Y, Kulak-Ozkan Y. Five-year treatment outcomes with three brands of implants supporting mandibular overdentures. Int J Oral Maxillofac Implants. 2011 Jan-Feb;26(1):188-94.
- Background: PubMed 22004061Cousson PY, Bessadet M, Nicolas E, Veyrune JL, Lesourd B, Lassauzay C. Nutritional status, dietary intake and oral quality of life in elderly complete denture wearers. Gerodontology. 2012 Jun;29(2):e685-92. doi: 10.1111/j.1741-2358.2011.00545.x. Epub 2011 Oct 17.
- Background: PubMed 19500236Evtimovska E, Masri R, Driscoll CF, Romberg E. The change in retentive values of locator attachments and hader clips over time. J Prosthodont. 2009 Aug;18(6):479-83. doi: 10.1111/j.1532-849X.2009.00474.x. Epub 2009 Jun 3.
- Background: PubMed 19912482Fromentin O, Lassauzay C, Abi Nader S, Feine J, de Albuquerque Junior RF. Testing the retention of attachments for implant overdentures - validation of an original force measurement system. J Oral Rehabil. 2010 Jan;37(1):54-62. doi: 10.1111/j.1365-2842.2009.02020.x. Epub 2009 Nov 11.
- Background: PubMed 28191678Sultana N, Bartlett DW, Suleiman M. Retention of implant-supported overdentures at different implant angulations: comparing Locator and ball attachments. Clin Oral Implants Res. 2017 Nov;28(11):1406-1410. doi: 10.1111/clr.13003. Epub 2017 Feb 13.
- Background: PubMed 20604812Ucankale M, Akoglu B, Ozkan Y, Ozkan YK. The effect of different attachment systems with implant-retained overdentures on maximum bite force and EMG. Gerodontology. 2012 Mar;29(1):24-9. doi: 10.1111/j.1741-2358.2010.00389.x. Epub 2010 Jun 30.
- Background: PubMed 25216129Uludag B, Polat S, Sahin V, Comut AA. Effects of implant angulations and attachment configurations on the retentive forces of locator attachment-retained overdentures. Int J Oral Maxillofac Implants. 2014 Sep-Oct;29(5):1053-7. doi: 10.11607/jomi.3401.
- Individual participant dataSharing planned: Undecided
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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.
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?
An observational study of Edentulous Jaw, run by Marmara University at 1 site in Turkey (Türkiye).
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 3 inclusion and 5 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 12 Mar 2024. 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 Turkey (Türkiye). 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?
Change in retention force (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05675566, which also lists 7 linked publications.
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 12 Mar 2024.