The Effect of a Removable Complete Denture Over One Implant in the Lower Jaw on Hearing Ability

NCT05744830 | Completed DMC

• 1 other identifier: UDDS-Prosth-01-2023
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Hearing

Keywords

Bone Conduction; Pure Tone Audiometry(PTA); Hearing ability; Single implant

Outcome Measures

Primary Outcomes (1)

• 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.

  hearing ability will be measured 3 days before and 1 month after using the removable complete denture.

Study Arms (2)

Overdenture

EXPERIMENTAL

Each patient in this group will receive a single implant overdenture.

Other: Overdenture

Complete Denture

EXPERIMENTAL

Each patient in this group will receive a removable complete denture without implants.

Other: Complete Denture

Interventions

Overdenture OTHER

15 patients will receive removable complete dentures, then a single implant is placed in the midline of the mandible, then loaded with the denture.

Overdenture

Complete Denture OTHER

15 patients will only receive removable complete dentures

Complete Denture

Eligibility Criteria

• Age: 50 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• 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.

Sponsors & Collaborators

• Damascus University: lead
• Al Mouwasat Hospital: collaborator

Study Sites (1)

Department of removable prosthodontics, University of Damascus Dental School

Damascus, Dimashq, 20872, Syria

Location

Related Publications (7)

• 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.

  PMID: 11280368 BACKGROUND

• Lawrence 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.

  PMID: 11669061 BACKGROUND

• Liddelow 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.

  PMID: 20234886 BACKGROUND

• Nagasaka 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.

  PMID: 12687730 BACKGROUND

• Peeters 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.

  PMID: 15089934 BACKGROUND

• Shreedhar 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.

  PMID: 32345511 BACKGROUND

• Jadaan 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.

  PMID: 41521677 DERIVED

MeSH Terms

Interventions

Denture, Overlay; Denture, Complete

Intervention Hierarchy (Ancestors)

Dentures; Dental Prosthesis; Prosthodontics; Dentistry; Prostheses and Implants; Equipment and Supplies

Study Officials

• Lujain Jadaan, DDS

  MSc student, Department of Prosthodotics, University of Damascus Dental School, Damascus

  PRINCIPAL INVESTIGATOR

• Ammar Almustafa, DDS MSc PhD

  Assistant Professor, Department of Prosthodotics, University of Damascus Dental School, Damascus

  STUDY DIRECTOR

• Samer Mohsen, MD MSc PhD

  Assistant Professor, Department of Audiology, Faculty of Medicine, Damascus University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: single blinding, the physician who does the audiogram
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2023
• First Posted: February 27, 2023
• Study Start: November 8, 2022
• Primary Completion: September 26, 2024
• Study Completion: September 26, 2025
• Last Updated: November 17, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)