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CompletedNCT05565261Updated Sep 8, 2023

Evaluation of Bite Force, Quality of Life, and Patients' Satisfaction

An observational study in Edentulous Jaw and Patient Satisfaction, sponsored by Eskisehir Osmangazi University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 47 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-08.

Sponsored by Eskisehir Osmangazi University · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
51
Ages
47 Years to 80 Years
Sex
All
01

Study summary

Objectives: The purpose of this study is to evaluate bite force (BF), oral health-related quality of life (OHRQoL), and patient satisfaction in 2-implant-supported overdentures. In addition, the effects of clinical parameters such as age, gender, implant length, implant diameter, locator attachment height, attachment color, and interimplant distance were also evaluated.

Material and Methods: A total of 51 patients were included in the study. BFs were measured with a force meter in complete dentures and implant-supported overdentures. OHRQoL was assessed with the Oral Health Impact Profile (OHIP-14) and patient satisfaction was assessed with the Visual Analog Scale (VAS).

Read the detailed description

New complete dentures with bilateral balanced occlusion were fabricated for the patients. The patients wore the prosthesis for at least 8 weeks to allow the muscles to adapt. After adaptation to the dentures, 2 dental implants (Astra Tech Implant System, Dentsply Sirona) were placed in the interforaminal region of the mandible. A minimum of 3 months was waited for the dental implants to osseointegrate. After osseointegration, a clinical examination of the prostheses was performed. The clinical examination evaluated the accuracy of the prostheses in terms of occlusion and vertical dimension, their adaptation to the tissue, and the health of the soft tissue. If cracks or fractures were present, the prosthesis was repaired, and if a defect in tissue adaptation was detected, the prostheses were idealized by relining. The OccluSense® computerized occlusion analysis system (Dr. Jean Bausch GmbH \& Co. KG, Cologne, Germany) was used to check occlusion evaluation, masticatory force distribution, and premature contact due to wear. In the case of premature contact, contacts were eliminated and the first bite force (BF) values of patients with correct occlusion were measured. The maximum BF was measured with a forcemeter (Akson, Istanbul, Turkey). The intraoral sensor of the device was placed unilaterally at the level of the 1st molar. To ensure stability, a bite block of the same thickness was placed in the contralateral dental arch. Patients were seated in a comfortable position with the Frankfurt horizontal plane parallel to the horizontal plane. Patients were asked to bite hard for 3 seconds and the measurement was repeated 3 times. To obtain a reliable value, patients rested for 1 minute after each measurement. The maximum BF was accepted as the highest value among the three bite forces. The mean value of the unilateral right and left measurements was used for data analysis. After measurement, the dentures were attached to the Locator Attachments (Zest Anchors LLC, Escondido, USA). Patients had to wait at least 8 weeks to adapt to the implant-supported overdentures. After the adaptation period, the second BF values of the patients wearing complete dentures in the maxilla and implant-supported overdentures in the mandible were measured.

Oral health-related quality of life and patients satisfaction In this phase, patients were asked to complete the OHIP-14 questionnaires to assess their quality of life and VAS forms to assess patient satisfaction. To assess the impact of clinical parameters, age, gender, implant lengths, implant diameters, locator attachment height, attachment color, and interimplant distance were also recorded.

OHRQoL was assessed using the Turkish version of the Oral Health Impact Profile (OHIP-14). Patients were asked to indicate how often the corresponding OHIP parameter occurred in the past month. OHIP-14 contains 14 questions related to 7 different main topics. The 7 main themes are functional limitations, physical pain, psychological discomfort, physical disability, psychological disability, social disability, and handicap. Patients answered the questions as 0 = Never, 1 = Rarely, 2 = Occasionally, 3 = Quite often, and 4 = Frequently. Scoring was based on 7 main categories and 8 data as the sum of all these categories. The total score of the OHIP-14 is at least 0 and the highest score is 56. A low score at the end of the test indicates a positive impact on OHRQoL, while a high score indicates a negative impact.

Patient satisfaction was measured with the questionnaire VAS. The questions in the questionnaires evaluated the comfort of the prosthesis, convenience in chewing, aesthetics, speech, stability, and ease of cleaning. Patients answered the questions with 5=Totally satisfied, 4=Satisfied, 3=Adequate, 2=Not satisfied, 1=Not at all satisfied. Higher scores indicate higher patient satisfaction.

02

Conditions studied

  • Edentulous Jaw
  • Patient Satisfaction

Keywords

  • bite force
  • complete denture
  • implant supported overdentures
  • patient satisfaction
  • quality of life
03

In context

Jaw, Edentulous

175 studies on the registry are indexed under Jaw, Edentulous; 24 are open to participants now.

This study's enrollment of 51 is above the median of 40 across 27 observational studies indexed under Jaw, Edentulous.

Browse Jaw, Edentulous studies →

Lead sponsor

Eskisehir Osmangazi University is the lead sponsor of 153 studies on the registry; 27 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
47 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Adult patients who were completely edentulous were included in the study.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients without pathology in intraoral tissues
  • Patients who have not experienced implant loss until the prosthesis stage
  • Patients without any systemic disease that would endanger the prognosis of the implant
  • Patients with good bilateral balanced occlusion
  • Patients who could understand and answer the questions in the questionnaire were included in the study.

Exclusion criteria

Exclusion Criteria:

  • Patients with parafunctional habits
  • Patients with masticatory muscles or temporomandibular joint complaints
  • Patients using drugs that affect muscle activity
  • Patients who did not come to the control session on time were excluded from the study.
05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
51 participants (actual)
Patient registry
No

Groups and cohorts

  • Group 1: Complete Dentures

    The group consists of patients using conventional complete dentures applied to edentulous patients.

    Device: complete denture

  • Group 2: Implant Supported Overdentures

    The group consists of patients who use implant-supported overdentures after 2 dental implants have been surgically placed in edentulous patients and osseointegration has occurred.

    Device: complete denture

Interventions

  • Devicecomplete denture

    Bite force was measured with a bite force measuring device. Quality of life and patient satisfaction were evaluated with questionnaires.

06

What researchers measure

Primary outcomes

  1. Bite force

    Bite force in Newton

    Time frame: December 2019-January 2022

  2. Interimplant distance

    Interimplant distance in millimeters

    Time frame: December 2019-January 2022

  3. The height of the locator attachment

    The height of the locator attachment is in millimeters.

    Time frame: December 2019-January 2022

  4. Quality of Life

    Quality of Life was assessed using the Oral Health Impact Profile(OHIP-14) (0-4 units, 0 for never to 4 for always).

    Time frame: December 2019-January 2022

  5. Patient satisfaction

    Patient satisfaction was assessed using the VAS(visual analogue scale, 1-5 units, 1 not satisfied to totally satisfied).

    Time frame: December 2019-January 2022

  6. Dental implant length

    Dental implant length in millimeters

    Time frame: December 2019-January 2022

  7. Dental implant diameter

    Dental implant diameter in millimeters

    Time frame: December 2019-January 2022

07

Study locations

1 site
  • Esra Nur Avukat
    Odunpazari, Eskişehir 26040, Turkey (Türkiye)
08

References and documents

Publications

  • Feine JS, Carlsson GE, Awad MA, Chehade A, Duncan WJ, Gizani S, Head T, Heydecke G, Lund JP, MacEntee M, Mericske-Stern R, Mojon P, Morais JA, Naert I, Payne AG, Penrod J, Stoker GT, Tawse-Smith A, Taylor TD, Thomason JM, Thomson WM, Wismeijer D. The McGill consensus statement on overdentures. Mandibular two-implant overdentures as first choice standard of care for edentulous patients. Gerodontology. 2002 Jul;19(1):3-4. No abstract available. PubMed 12164236 ↗
  • Thomason JM, Feine J, Exley C, Moynihan P, Muller F, Naert I, Ellis JS, Barclay C, Butterworth C, Scott B, Lynch C, Stewardson D, Smith P, Welfare R, Hyde P, McAndrew R, Fenlon M, Barclay S, Barker D. Mandibular two implant-supported overdentures as the first choice standard of care for edentulous patients--the York Consensus Statement. Br Dent J. 2009 Aug 22;207(4):185-6. doi: 10.1038/sj.bdj.2009.728. PubMed 19696851 ↗
  • Mumcu E, Bilhan H, Geckili O. The effect of attachment type and implant number on satisfaction and quality of life of mandibular implant-retained overdenture wearers. Gerodontology. 2012 Jun;29(2):e618-23. doi: 10.1111/j.1741-2358.2011.00531.x. Epub 2011 Jul 4. PubMed 21726276 ↗
  • Muller F, Duvernay E, Loup A, Vazquez L, Herrmann FR, Schimmel M. Implant-supported mandibular overdentures in very old adults: a randomized controlled trial. J Dent Res. 2013 Dec;92(12 Suppl):154S-60S. doi: 10.1177/0022034513509630. Epub 2013 Oct 24. PubMed 24158342 ↗
  • Wang Y, Baumer D, Ozga AK, Korner G, Baumer A. Patient satisfaction and oral health-related quality of life 10 years after implant placement. BMC Oral Health. 2021 Jan 14;21(1):30. doi: 10.1186/s12903-020-01381-3. PubMed 33446161 ↗
  • Enkling N, Saftig M, Worni A, Mericske-Stern R, Schimmel M. Chewing efficiency, bite force and oral health-related quality of life with narrow diameter implants - a prospective clinical study: results after one year. Clin Oral Implants Res. 2017 Apr;28(4):476-482. doi: 10.1111/clr.12822. Epub 2016 Mar 24. PubMed 27009835 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Dec 2019 to primary completion in Jan 2022, 24 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 23, 2022
First posted
Oct 4, 2022
StartActual
Dec 17, 2019
Primary completionActual
Jan 15, 2022
CompletionActual
Jan 15, 2022
Last update
Sep 8, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 8, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05565261
Responsible party
Esra Nur Avukat (Principal Investigator, Eskisehir Osmangazi University) — Principal investigator
First posted
Oct 4, 2022
Start date
Dec 17, 2019
Primary completion
Jan 15, 2022
Completion
Jan 15, 2022
Last update
Sep 8, 2023

Study contacts

Esra Avukat
principal investigator · Research Assistant

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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