Complete dentures vs implant prosthesis: a clinical study about which intervention results in better sensory functioning
| ISRCTN | ISRCTN44091392 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN44091392 |
- Submission date
- 23/08/2022
- Registration date
- 31/08/2022
- Last edited
- 01/03/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
Edentulism (the condition of having no teeth) is a common condition encountered in dental offices today. For a long time, dentists have designed different prosthetics to solve this problem. Complete conventional dentures have been a common solution to restore chewing function in patients with no teeth. Dental implants have become a great alternative to this kind of prosthesis. When there are no teeth, patients find it hard to eat and chew in a proper way because the teeth provide a lot of sensory information that is important to perform these functions correctly. This can be measured with tactile investigations to find out if a dental rehabilitation is precise or not while chewing or eating. The aim of this study is to find out if there is improved performance in patients treated with dental implants compared with conventional complete dentures.
Who can participate?
Healthy adults aged 18-99 years with dental implants or complete dentures that are well adapted and adjusted
What does the study involve?
This study will be performed in three groups of patients with three different prosthetics. Group A consists of people who wear complete dentures in both arches (i.e. both jaws), group B consists of people with an implant prosthesis in both arches, and group C consists of people with an implant prosthesis in one arch and natural teeth in the other. This distribution of groups will show which receptors are activated during chewing in every prosthetic situation. The test consists of introducing thin metal foils between the patient’s teeth to see if they are able to notice them while chewing. Foils of three different thicknesses are used and after the test every patient will present a minimum threshold that will match the thinnest foil. Age, gender and prosthesis wearing time are also collected to see if they have any influence.
What are the possible benefits and risks of participating?
The main benefit is to demonstrate that dental implants are a better solution to restore missed teeth rather than complete dentures. In this way, it will be possible to improve dental prostheses and patients will have better oral function. There are no risks in this study as it consists of biting metal foils that are harmless to the patient. This procedure is very similar to the dental adjustment performed in dental offices routinely.
Where is the study run from?
University of Salamanca (Spain)
When is the study starting and how long is it expected to run for?
September 2021 to May 2022
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Diego González Gil, diegoggil@usal.es
Contact information
Principal Investigator
Facultad de Medicina C/ Alfonso X el Sabio s/n
Salamanca
37007
Spain
| Phone | +34 (0)679765668 |
|---|---|
| diegoggil@usal.es |
Study information
| Study design | Multicentre psychophysical study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Psychophysical study |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Active tactile sensibility in complete dentures vs implant prosthesis: a psychophysical study |
| Study acronym | Act Tact Sens in CD Vs. IP |
| Study objectives | Patients wearing an implant prosthesis have better active tactile sensibility than complete denture wearers. |
| Ethics approval(s) | Approval 08/02/2022, comité bioético de la universidad de Salamanca (bioethics committee of the University of Salamanca, Patio de escuelas, 1. Edificio i+d+i. Salamanca 37008, Spain; +34 (0)923 294430; vic.investigacion@usal.es), ref: 739 |
| Health condition(s) or problem(s) studied | Edentulism |
| Intervention | Psychophysical study for measuring active tactile sensibility in dental implants and complete dentures. Three groups with different prosthetic rehabilitations will be measured for 5 months: Group A: patients wearing complete dentures in both dental arches Group B: patients rehabilitated with implant prosthesis in both arches Group C: patients wearing implant prostheses whose antagonists are natural teeth Aluminium thin foils will be introduced to the patient's mouth and they will have to say if they can perceive them while eating. The minimum thickness perceived will be the tactile sensibility threshold of each group. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | The minimum threshold of tactile sensibility (the thinnest foil perceived) measured in microns using an active tactile sensibility psychophysical investigation at a single timepoint |
| Secondary outcome measures | Age, gender and prosthetic wearing time measured using a questionnaire at a single timepoint |
| Overall study start date | 01/09/2021 |
| Completion date | 01/05/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Sex | Both |
| Target number of participants | 70 |
| Total final enrolment | 67 |
| Key inclusion criteria | Adults with good oral health and wearing a well-adapted prosthesis |
| Key exclusion criteria | 1. Temporomandibular disorders 2. Not well-adapted prosthesis 3. Patients who are unable to understand this procedure |
| Date of first enrolment | 16/02/2022 |
| Date of final enrolment | 21/02/2022 |
Locations
Countries of recruitment
- Spain
Study participating centres
Faculty of Medicine
C/ Alfonso X el sabio s/n 37007
Salamanca
37007
Spain
Santa Marta de Tormes
37900
Spain
Sponsor information
University/education
Calle Alfonso X el sabio s/n
Salamanca
37007
Spain
| Phone | +34 (0)923294541 |
|---|---|
| dec.fm@usal.es | |
| Website | http://www.usal.es/webusal/en |
"ROR" |
https://ror.org/02f40zc51 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/03/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 18/11/2022 | 01/03/2023 | Yes | No |
Editorial Notes
01/03/2023: Publication reference and total final enrolment added.
31/08/2022: Trial's existence confirmed by the bioethics committee of the University of Salamanca.
