HearingNCT05744830
The Effect of a Removable Complete Denture Over One Implant in the Lower Jaw on Hearing Ability
A study testing Overdenture and Complete Denture in people with Hearing, run by Damascus University at 1 site in Syria.
Trial summary
The effect of a removable complete denture and the insertion of one implant in the lower jaw and the loading of this implant on the hearing ability of patients will be studied, so the hearing ability will be measured by using the PTA test for 30 patients in the age of 50-65 years old. Read more about this study
- Who is it for?
- Ages 50 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hearing
- What is being tested?
- Overdenture and Complete Denture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSyria
- Study dates
- 8 Nov 2022to 26 Sep 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 50 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age between 50-65 years old.
- No previous experience in removable complete dentures.
- Enough bone in the midline of the mandibular jaw that permits the placement of a single implant no less than 10 mm in length and 3.4 mm in width.
- Hearing threshold of the patient between 40-70 decibel.
- The ability of the patient to fill out the questionnaire and commit to follow up sessions.
Who cannot join
- Having one of the variables that are connected with hearing loss, which are:
- usage of hearing aids.
- Uncontrolled diabetes.
- Uncontrolled hypertension.
- Balance problems.
- In addition to risk factors that are associated with hearing loss, which are:
Show all 12Show fewer
- stroke
- kidney disease
- In addition to contraindications for implant surgery, which are:
- definitive contraindications: Recent myocardial infarction, valve replacements, cardiovascular diseases ,and presence of immunodeficiency, bleeding problems, drug abuse, and psychological disease.
- Relative contraindications:
- Osteoporosis, heavy smoking, uncontrolled diabetes, hypothyroidism.
Trial locations and contacts
1 site in 1 country.
Syria1 site
Department of removable prosthodontics, University of Damascus Dental School
Damascus, Damascus Governorate, 20872
About this study
Official title: The Effect of a Single Implant Retained Removable Complete Overdenture in the Mandible on Hearing Ability of Edentulous Patients- Randomised Controlled Trial
The effect of a removable complete denture and the insertion of one implant in the lower jaw and the loading of this implant on the hearing ability of patients will be studied, so the hearing ability will be measured by using the PTA test for 30 patients in the age of 50-65 years old. The hearing ability measurement will be done in 4 different periods of time. Before and after using the denture, before and after the implant insertion, and after loading the implant with the same complete denture. The implant surgery will be done in two phases: the first is to insert the implant in the bone and cover it by suturing until it integrates with the bone after 3 months, the second is to start the process of loading the implant with the denture.
Read the detailed description
Tanaka et al mentioned in their study that in accordance to the WHO, about one third of the people older than 65 years old is somehow affected by hearing loss. Although hearing loss is not a life-threatening condition but it is related to medical and psychological problems such as depression and social isolation. Reduction in the occlusal vertical dimension is considered one of the factors that cause a decline in hearing ability. A study of Shreedhar et al found that there is improvement in hearing ability between loading two implants in the canine regions in the mandible with a removable complete overdenture and after one month of the loading. In their study, the hearing threshold improved from 40 to 25 decibel and the improvement is associated with transmission of vibrations from the oral cavity through the bone. Implants in the mandible has been associated with improvement in hearing although the mandible is not in direct contact with the skull, and Ozer et al study found that the hearing acuity through the bone was not different between the upper and lower jaw. In Tanaka et al study teeth loss was associated with the increased prevalence of hearing loss. King et al found important improvement in previously existed hearing loss after the replacement of missing teeth with a removable complete overdenture. Furthermore, Schell et al study found that hearing acuity was worse in the edentulous patients group than the other groups, which suggests a relation between hearing loss and the dentate status. A similar study of Peeters et al mentioned that the discrepancy between patients who had complete dentures and patients who had loss in the occlusal vertical dimension strengthen the hypothesis that there is an association between hearing loss and the occlusal vertical dimension. As for the single implant retained complete overdenture, there has been several studies, which are mentioned in carl's Misch book that found this treatment to be valid, especially for patients who suffer from removable dentures and have problems in mastication.
The available evidence on the relationship between dentate status and hearing loss is limited, so understanding this relationship could help prevent or delay the occurrence of hearing loss. The possibility of suggesting implant placement and loading the implant with a removable complete overdenture as a way to improve bone-conducted hearing in edentulous patients will be studied.
In this study, we are going to measure the hearing ability of edentulous patients 4 times: First, before using the complete denture. Second, after using it for one month and before placing the implant. Third, 10 days after placing the implant in the midline of the mandibular jaw. Fourth, after 1 month of loading the implant with the removable complete overdenture. The null hypothesis is that there is no statistically important difference in hearing thresholds by bone conduction between the studied periods of time. This study will be done on 30 patients and a written consent will be taken. The hearing ability test will be done in Al-Mowasat hospital after the examination of the patient by an otolaryngologist before the first hearing test. The hearing ability test is called Pure Tone Audiometry or PTA.
- Conditions
- Hearing
- Being tested
- Overdenture, Complete Denture
- Keywords
- Bone Conduction, Pure Tone Audiometry(PTA), Hearing ability, Single implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OverdentureOther
15 patients will receive removable complete dentures, then a single implant is placed in the midline of the mandible, then loaded with the denture.
Complete DentureOther
15 patients will only receive removable complete dentures
| Study group | Role | What they receive |
|---|---|---|
| Overdenture | Experimental | Each patient in this group will receive a single implant overdenture. Receives: Other: Overdenture |
| Complete Denture | Experimental | Each patient in this group will receive a removable complete denture without implants. Receives: Other: Complete Denture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hearing ability of edentulous patients
Hearing ability is expressed in the present study as hearing threshold (HT) measured by pure tone audiometry (PTA). PTA is performed by producing auditory stimuli from headphones strating from 30 decibels (dB). A gradual increase by 15dB is implemented until HT is reached. HT value is recorded when the participant hears the lowest tone and raises his/her hand.
Measured: hearing ability will be measured 3 days before and 1 month after using the removable complete denture.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2023
- Study start8 Nov 2022
- Primary completion26 Sep 2024
- Study completion26 Sep 2025
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 HearingStudies 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Collaborators
- Al Mouwasat Hospital
- Responsible party
- Sponsor
- Investigators
- Lujain Jadaan, DDS, Principal investigator, MSc student, Department of Prosthodotics, University of Damascus Dental School, DamascusAmmar Almustafa, DDS MSc PhD, Study director, Assistant Professor, Department of Prosthodotics, University of Damascus Dental School, DamascusSamer Mohsen, MD MSc PhD, Study director, Assistant Professor, Department of Audiology, Faculty of Medicine, Damascus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05744830
- Sponsor's protocol ID
- UDDS-Prosth-01-2023
- Status last verified
- Nov 2025
- First submitted
- 7 Feb 2023
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Krennmair G, Ulm C. The symphyseal single-tooth implant for anchorage of a mandibular complete denture in geriatric patients: a clinical report. Int J Oral Maxillofac Implants. 2001 Jan-Feb;16(1):98-104.
PubMed 11280368Lawrence HP, Garcia RI, Essick GK, Hawkins R, Krall EA, Spiro A 3rd, Vokonas PS, Kong L, King T, Koch GG. A longitudinal study of the association between tooth loss and age-related hearing loss. Spec Care Dentist. 2001 Jul-Aug;21(4):129-40. doi: 10.1111/j.1754-4505.2001.tb00242.x.
PubMed 11669061Liddelow G, Henry P. The immediately loaded single implant-retained mandibular overdenture: a 36-month prospective study. Int J Prosthodont. 2010 Jan-Feb;23(1):13-21.
PubMed 20234886Nagasaka H, Matsukubo T, Takaesu Y, Kobayashi Y, Sato T, Ishikawa T. Changes and equalization in hearing level induced by dental treatment and instruction in bilaterally equalized chewing: a clinical report. Bull Tokyo Dent Coll. 2002 Nov;43(4):243-50. doi: 10.2209/tdcpublication.43.243.
PubMed 12687730Peeters J, Naert I, Carette E, Manders E, Jacobs R. A potential link between oral status and hearing impairment: preliminary observations. J Oral Rehabil. 2004 Apr;31(4):306-10. doi: 10.1046/j.1365-2842.2003.01252.x.
PubMed 15089934Shreedhar S, Raza FB, Vaidyanathan AK, Veeravalli PT. Effect of an implant-retained complete overdenture on the hearing ability of edentulous patients: A clinical pilot study. J Prosthet Dent. 2021 Apr;125(4):628-635. doi: 10.1016/j.prosdent.2020.02.015. Epub 2020 Apr 26.
PubMed 32345511Jadaan L, Mohsen S, Almustafa A. Hearing of Edentulous Patients With a Single Implant-Retained Removable Complete Overdenture: A Case Series. Spec Care Dentist. 2026 Jan-Feb;46(1):e70138. doi: 10.1111/scd.70138.
PubMed 41521677
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Single Implant Retained Removable Complete Overdenture in the Mandible on Hearing Ability of Edentulous Patients- Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05744830
- Acronym / sponsor ID
- UDDS-Prosth-01-2023
- Conditions
- Hearing
- Keywords
- Bone Conduction, Pure Tone Audiometry(PTA), Hearing ability, Single implant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Collaborators
- Al Mouwasat Hospital
- Study start
- 8 Nov 2022 (actual)
- Primary completion
- 26 Sep 2024 (actual)
- Study completion
- 26 Sep 2025 (actual)
- First posted
- 27 Feb 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.
The effect of a removable complete denture and the insertion of one implant in the lower jaw and the loading of this implant on the hearing ability of patients will be studied, so the hearing ability will be measured by using the PTA test for 30 patients in the age of 50-65 years old. The hearing ability measurement will be done in 4 different periods of time. Before and after using the denture, before and after the implant insertion, and after loading the implant with the same complete denture. The implant surgery will be done in two phases: the first is to insert the implant in the bone and cover it by suturing until it integrates with the bone after 3 months, the second is to start the process of loading the implant with the denture.
Detailed description
Tanaka et al mentioned in their study that in accordance to the WHO, about one third of the people older than 65 years old is somehow affected by hearing loss. Although hearing loss is not a life-threatening condition but it is related to medical and psychological problems such as depression and social isolation. Reduction in the occlusal vertical dimension is considered one of the factors that cause a decline in hearing ability. A study of Shreedhar et al found that there is improvement in hearing ability between loading two implants in the canine regions in the mandible with a removable complete overdenture and after one month of the loading. In their study, the hearing threshold improved from 40 to 25 decibel and the improvement is associated with transmission of vibrations from the oral cavity through the bone. Implants in the mandible has been associated with improvement in hearing although the mandible is not in direct contact with the skull, and Ozer et al study found that the hearing acuity through the bone was not different between the upper and lower jaw. In Tanaka et al study teeth loss was associated with the increased prevalence of hearing loss. King et al found important improvement in previously existed hearing loss after the replacement of missing teeth with a removable complete overdenture. Furthermore, Schell et al study found that hearing acuity was worse in the edentulous patients group than the other groups, which suggests a relation between hearing loss and the dentate status. A similar study of Peeters et al mentioned that the discrepancy between patients who had complete dentures and patients who had loss in the occlusal vertical dimension strengthen the hypothesis that there is an association between hearing loss and the occlusal vertical dimension. As for the single implant retained complete overdenture, there has been several studies, which are mentioned in carl's Misch book that found this treatment to be valid, especially for patients who suffer from removable dentures and have problems in mastication.
The available evidence on the relationship between dentate status and hearing loss is limited, so understanding this relationship could help prevent or delay the occurrence of hearing loss. The possibility of suggesting implant placement and loading the implant with a removable complete overdenture as a way to improve bone-conducted hearing in edentulous patients will be studied.
In this study, we are going to measure the hearing ability of edentulous patients 4 times: First, before using the complete denture. Second, after using it for one month and before placing the implant. Third, 10 days after placing the implant in the midline of the mandibular jaw. Fourth, after 1 month of loading the implant with the removable complete overdenture. The null hypothesis is that there is no statistically important difference in hearing thresholds by bone conduction between the studied periods of time. This study will be done on 30 patients and a written consent will be taken. The hearing ability test will be done in Al-Mowasat hospital after the examination of the patient by an otolaryngologist before the first hearing test. The hearing ability test is called Pure Tone Audiometry or PTA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Overdenture | Experimental | Other: OverdentureEach patient in this group will receive a single implant overdenture. |
| Complete Denture | Experimental | Other: Complete DentureEach patient in this group will receive a removable complete denture without implants. |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 50-65 years old.
- No previous experience in removable complete dentures.
- Enough bone in the midline of the mandibular jaw that permits the placement of a single implant no less than 10 mm in length and 3.4 mm in width.
- Hearing threshold of the patient between 40-70 decibel.
- The ability of the patient to fill out the questionnaire and commit to follow up sessions.
Key exclusion criteria (12 listed)
- usage of hearing aids.
- Uncontrolled diabetes.
- Uncontrolled hypertension.
- Balance problems.
- stroke
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 |
|---|---|---|
| Overdenture15 patients will receive removable complete dentures, then a single implant is placed in the midline of the mandible, then loaded with the denture. | Other | Overdenture |
| Complete Denture15 patients will only receive removable complete dentures | Other | Complete Denture |
Primary outcome
Hearing ability of edentulous patients
Time frame: hearing ability will be measured 3 days before and 1 month after using the removable complete denture.
Hearing ability is expressed in the present study as hearing threshold (HT) measured by pure tone audiometry (PTA). PTA is performed by producing auditory stimuli from headphones strating from 30 decibels (dB). A gradual increase by 15dB is implemented until HT is reached. HT value is recorded when the participant hears the lowest tone and raises his/her hand.
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 17 Nov 2025.
- Background: PubMed 11280368Krennmair G, Ulm C. The symphyseal single-tooth implant for anchorage of a mandibular complete denture in geriatric patients: a clinical report. Int J Oral Maxillofac Implants. 2001 Jan-Feb;16(1):98-104.
- Background: PubMed 11669061Lawrence HP, Garcia RI, Essick GK, Hawkins R, Krall EA, Spiro A 3rd, Vokonas PS, Kong L, King T, Koch GG. A longitudinal study of the association between tooth loss and age-related hearing loss. Spec Care Dentist. 2001 Jul-Aug;21(4):129-40. doi: 10.1111/j.1754-4505.2001.tb00242.x.
- Background: PubMed 20234886Liddelow G, Henry P. The immediately loaded single implant-retained mandibular overdenture: a 36-month prospective study. Int J Prosthodont. 2010 Jan-Feb;23(1):13-21.
- Background: PubMed 12687730Nagasaka H, Matsukubo T, Takaesu Y, Kobayashi Y, Sato T, Ishikawa T. Changes and equalization in hearing level induced by dental treatment and instruction in bilaterally equalized chewing: a clinical report. Bull Tokyo Dent Coll. 2002 Nov;43(4):243-50. doi: 10.2209/tdcpublication.43.243.
- Background: PubMed 15089934Peeters J, Naert I, Carette E, Manders E, Jacobs R. A potential link between oral status and hearing impairment: preliminary observations. J Oral Rehabil. 2004 Apr;31(4):306-10. doi: 10.1046/j.1365-2842.2003.01252.x.
- Background: PubMed 32345511Shreedhar S, Raza FB, Vaidyanathan AK, Veeravalli PT. Effect of an implant-retained complete overdenture on the hearing ability of edentulous patients: A clinical pilot study. J Prosthet Dent. 2021 Apr;125(4):628-635. doi: 10.1016/j.prosdent.2020.02.015. Epub 2020 Apr 26.
- Derived from this study: PubMed 41521677Jadaan L, Mohsen S, Almustafa A. Hearing of Edentulous Patients With a Single Implant-Retained Removable Complete Overdenture: A Case Series. Spec Care Dentist. 2026 Jan-Feb;46(1):e70138. doi: 10.1111/scd.70138.
- Individual participant dataSharing planned: No
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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.
Lujain Jadaan, DDS principal investigator
MSc student, Department of Prosthodotics, University of Damascus Dental School, Damascus
Ammar Almustafa, DDS MSc PhD study director
Assistant Professor, Department of Prosthodotics, University of Damascus Dental School, Damascus
Samer Mohsen, MD MSc PhD study director
Assistant Professor, Department of Audiology, Faculty of Medicine, Damascus 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 Overdenture and Complete Denture in people with Hearing, run by Damascus University at 1 site in Syria.
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 5 inclusion and 12 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 17 Nov 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 Syria. 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?
Hearing ability of edentulous patients (time frame: hearing ability will be measured 3 days before and 1 month after using the removable complete denture.). 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 NCT05744830, 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 17 Nov 2025.