Edentulous JawNCT05565261
Evaluation of Bite Force, Quality of Life, and Patients' Satisfaction
An observational study of Edentulous Jaw and Patient Satisfaction, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 47 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Edentulous Jaw, Patient Satisfaction
- What is being tested?
- complete denture
- Type of treatment
- Medical device
- How many people
- 51 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Dec 2019to 15 Jan 2022
- Phase
- Observational
- 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 47 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult patients who were completely edentulous were included in the study.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Edentulous Jaw, Patient Satisfaction
- Being tested
- complete denture
- Keywords
- bite force, complete denture, implant supported overdentures, patient satisfaction, quality of life
- Medical subject headings
- Jaw, Edentulous, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
complete dentureDevice
Bite force was measured with a bite force measuring device. Quality of life and patient satisfaction were evaluated with questionnaires.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Complete Dentures | The group consists of patients using conventional complete dentures applied to edentulous patients. Receives: 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. Receives: Device: complete denture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bite force
Bite force in Newton
Measured: December 2019-January 2022
Interimplant distance
Interimplant distance in millimeters
Measured: December 2019-January 2022
The height of the locator attachment
The height of the locator attachment is in millimeters.
Measured: December 2019-January 2022
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).
Measured: December 2019-January 2022
Patient satisfaction
Patient satisfaction was assessed using the VAS(visual analogue scale, 1-5 units, 1 not satisfied to totally satisfied).
Measured: December 2019-January 2022
Dental implant length
Dental implant length in millimeters
Measured: December 2019-January 2022
Dental implant diameter
Dental implant diameter in millimeters
Measured: December 2019-January 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2022
- Study start17 Dec 2019
- Primary completion15 Jan 2022
- Study completion15 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Edentulous JawStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eskisehir Osmangazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esra Nur Avukat, Eskisehir Osmangazi University
- Investigators
- Esra Avukat, Principal investigator, Research Assistant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05565261
- Sponsor's protocol ID
- EAvukat
- Status last verified
- Sep 2023
- First submitted
- 23 Jun 2022
- Last updated
- 8 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 12164236Thomason 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 19696851Mumcu 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 21726276Muller 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 24158342Wang 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 33446161Enkling 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
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05565261
- Acronym / sponsor ID
- EAvukat
- Conditions
- Edentulous Jaw, Patient Satisfaction
- Keywords
- bite force, complete denture, implant supported overdentures, patient satisfaction, quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Eskisehir Osmangazi UniversityUniversity, hospital or other
- Study start
- 17 Dec 2019 (actual)
- Primary completion
- 15 Jan 2022 (actual)
- Study completion
- 15 Jan 2022 (actual)
- First posted
- 4 Oct 2022 (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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Complete Dentures | – | Device: complete dentureThe group consists of patients using conventional complete dentures applied to edentulous patients. |
| Group 2: Implant Supported Overdentures | – | Device: complete dentureThe group consists of patients who use implant-supported overdentures after 2 dental implants have been surgically placed in edentulous patients and osseointegration has occurred. |
Who may qualify
- Ages
- 47 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients who were completely edentulous were included in the study.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| complete dentureBite force was measured with a bite force measuring device. Quality of life and patient satisfaction were evaluated with questionnaires. | Device | Group 1: Complete Dentures, Group 2: Implant Supported Overdentures |
Primary outcome
Bite force
Time frame: December 2019-January 2022
Bite force in Newton
Interimplant distance
Time frame: December 2019-January 2022
Interimplant distance in millimeters
The height of the locator attachment
Time frame: December 2019-January 2022
The height of the locator attachment is in millimeters.
Quality of Life
Time frame: December 2019-January 2022
Quality of Life was assessed using the Oral Health Impact Profile(OHIP-14) (0-4 units, 0 for never to 4 for always).
Patient satisfaction
Time frame: December 2019-January 2022
Patient satisfaction was assessed using the VAS(visual analogue scale, 1-5 units, 1 not satisfied to totally satisfied).
Dental implant length
Time frame: December 2019-January 2022
Dental implant length in millimeters
Dental implant diameter
Time frame: December 2019-January 2022
Dental implant diameter in millimeters
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 8 Sep 2023.
- Results publication: PubMed 12164236Feine 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.
- Results publication: PubMed 19696851Thomason 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.
- Results publication: PubMed 21726276Mumcu 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.
- Results publication: PubMed 24158342Muller 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.
- Results publication: PubMed 33446161Wang 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.
- Results publication: PubMed 27009835Enkling 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.
- 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.
Esra Avukat principal investigator
Research Assistant
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Edentulous Jaw and Patient Satisfaction, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
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 4 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 8 Sep 2023. 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 Turkey (Türkiye). 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?
Bite force (time frame: December 2019-January 2022). The study lists 7 primary outcomes in all. 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 NCT05565261, which also lists 6 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 8 Sep 2023.