Clinical trial NCT05565261: Evaluation of Bite Force, Quality of Life, and Patients' Satisfaction
Official title: Evaluation of Bite Force, Quality of Life, and Patients' Satisfaction of Edentulous Patients Using Complete Dentures and Implant-Supported Overdentures: An in Vivo Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Edentulous Jaw
Patient Satisfaction
Keywords: bite force
complete denture
implant supported overdentures
patient satisfaction
quality of life
Lead sponsor: Eskisehir Osmangazi University
Sponsor class: OTHER
First posted: 2022-10-04
Enrollment: 51
Sex: ALL
Minimum age (years): 47
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients who were completely edentulous were included in the study.

Brief 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).

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.

Eligibility criteria: 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:

* 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.

Primary outcomes:
measure: Bite force
timeFrame: December 2019-January 2022
measure: Interimplant distance
timeFrame: December 2019-January 2022
measure: The height of the locator attachment
timeFrame: December 2019-January 2022
measure: Quality of Life
timeFrame: December 2019-January 2022
measure: Patient satisfaction
timeFrame: December 2019-January 2022
measure: Dental implant length
timeFrame: December 2019-January 2022
measure: Dental implant diameter
timeFrame: December 2019-January 2022
Secondary outcomes:
Other outcomes:
Locations:
city: Odunpazarı
country: Turkey
facility: Esra Nur Avukat
state: Eskişehir
Study officials:
affiliation: Research Assistant
name: Esra Avukat
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
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