Impact of a Denture and Implant on Hearing Ability
The Effect of a Single Implant Retained Removable Complete Overdenture in the Mandible on Hearing Ability of Edentulous Patients- Randomised Controlled Trial
NA · Damascus University · NCT05744830
This study is testing if using a removable denture along with a dental implant can help improve hearing in people aged 50 to 65 who have hearing loss.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 50 Years to 65 Years |
| Sex | All |
| Sponsor | Damascus University (other) |
| Locations | 1 site (Damascus, Dimashq) |
| Trial ID | NCT05744830 on ClinicalTrials.gov |
What this trial studies
This study investigates how a removable complete denture combined with a single implant in the lower jaw affects hearing ability in patients aged 50-65. The research will measure hearing ability using Pure Tone Audiometry (PTA) at four different time points: before and after using the denture, before and after implant insertion, and after loading the implant. The implant procedure will occur in two phases, with a three-month healing period before the denture is attached. The goal is to determine if this intervention can improve hearing thresholds in patients with hearing loss.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 50-65 who have not previously used removable complete dentures and have a specific range of hearing loss.
Not a fit: Patients with existing hearing aids, uncontrolled medical conditions, or contraindications for implant surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could enhance hearing ability and improve the quality of life for patients with hearing loss related to dental issues.
How similar studies have performed: Previous studies have shown improvements in hearing ability with similar interventions, suggesting a promising avenue for further exploration.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: 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: * stroke * kidney disease In addition to contraindications for implant surgery, which are: 1. definitive contraindications: Recent myocardial infarction, valve replacements, cardiovascular diseases ,and presence of immunodeficiency, bleeding problems, drug abuse, and psychological disease. 2. Relative contraindications: Osteoporosis, heavy smoking, uncontrolled diabetes, hypothyroidism.
Where this trial is running
Damascus, Dimashq
- Department of removable prosthodontics, University of Damascus Dental School — Damascus, Dimashq, Syrian Arab Republic (RECRUITING)
Study contacts
- Principal investigator: Lujain Jadaan, DDS — MSc student, Department of Prosthodotics, University of Damascus Dental School, Damascus
- Study coordinator: Ammar Almustafa, DDS MSc PhD
- Email: d.ammar.almustafa@gmail.com
- Phone: +963-944627858
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hearing, Bone Conduction, Pure Tone Audiometry, Hearing ability, Single implant