OHIP study in edentulous population
| ISRCTN | ISRCTN99907946 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN99907946 |
| Secondary identifying numbers | 03-67-1/14 |
- Submission date
- 23/01/2018
- Registration date
- 02/02/2018
- Last edited
- 23/01/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
People who have lost teeth (edentulous) can be treated with false teeth (dentures). The process of making dentures is relatively quick and can take around one or two weeks. Patients also have to go through a process of adaptation to the dentures. During this period of adaptation, certain corrections need to be made. The corrections could be related to the base of the denture, to the artificial teeth in the dentures, or both. This study aims to recruit and observe about denture wearers to look at the improvement in their treatment and satisfaction with their dentures after adequate corrections.
Who could participate?
Patients over 60 years of age who require complete dentures
What does this study involve?
The participants are interviewed and observed immediately after receiving their dentures. After selected and appropriate interventions either on the base of the dentures or the surfaces of the artificial teeth, the patients are examined and interviewed again to complete a quality of life questionnaire after 90 days, 5 years and 9-10 years.
What are possible risks or benefits to the patients?
The study findings should show how to improve patients’ satisfaction with their dentures. Generally, the patients are treated with conventional methods. There are no possible dangers and risks of the denture treatment, except when patients require insertion of implants into the jawbone.
Where is the study run from?
This study is run from towns and regional medical centers in central Bosnia
When is this study starting and how long it will last?
September 2016 to September 2019
Who is funding this study?
The Faculty of Pharmacy and Medicine and Dental Medical Center in Travnik (Bosnia)
Who is the main contact?
Associate Professor Srđan D. Poštić
sdposticdent@yahoo.com
Contact information
Scientific
Rankeova 4
Beograd
11000
Serbia
 ORCID ID |
0000-0001-9640-3282 |
|---|
Scientific
Slavka Gavrančića 17
Travnik-Dolac na Lašvi
72270
Bosnia and Herzegovina
Study information
| Study design | Multi-centre randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | OHIP study in institutionalized and non-institutionalized terminally edentulous and edentulous complete denture wearers in Central Bosnia |
| Study objectives | The study hypothesis is that additional interventions on the acrylic complete dentures will provide benefit in oral quality of life and long-lasting treatment effects for denture wearers. |
| Ethics approval(s) | Ethics Committee of the FZF-Pharmaceutical-Health Faculty in Travnik, B and H Federation, 03/03/2014, ref: 03-67-1/14 |
| Health condition(s) or problem(s) studied | Quality of life and quality of oral condition |
| Intervention | The first study arm The first study arm is related to small interventions on the base of the acrylic denture by removal of small amounts of polymerized acrylic within existing denturing bases towards opposing peak of edentulous ridges as well as small corrections of occlusion (occlusal corrections based on an intensity of the marks on occlusal surfaces of artificial teeth using 60 μm and 40 μm articulating papers) (Other: BK 09 Blue Bausch Thin Articulating Papers 40 microns and BK-17 Blue Bausch Thin Articulating Papers Item #/Vendor: 310098 / BK 17-0024"/60 microns, Bausch dental GmbH&Co, Koln, Germany, EU). The first study arm is expected to be applied not only for the great majority of a patients, but probably for all of the patients of this study (n=129). The randomization process will follow subjective remarks and objections of patients, as well as objective findings of the investigator-specialist of dental prosthetic. Follow-ups will be tracked immediately after the baseline (T=0), and in the initial beginning period of 1, 2, 3, 4, up to 9 months after delivery and positioning of the dentures in the mouth of the patients. The second study arm Initially corrected existing bases of the complete acrylic dentures will be either relined with soft silicone-based denture liner (Other: Major Total Soft, polyvinyl siloxane liner, Major Prodotti, Dentari S.p.A., Italy, EU) and then, after necessary period of adaptation (up to two months) rebased (Other: Rebasing material: Akrilat- R, self-curing acrylate for reparations, Laser Dental Products, Serbia, Europa) on selected area of the base of the dentures, or rebasing would have been primarily and only conducted using auto-curing acrylate (Other-. Active Comparator: Denture liner autopolymerizing resin-cooliner- rebasing material: Akrilat- R, self-curing acrylate for reparations, Laser Dental Products, Serbia, Europa), with chairside procedures. The randomization process will be based on subjective demands and objective findings respecting specific needs or conditions of edentulous patients. It is expected that more than 1/3 of patients (n=50) will go through this procedure in the period of 3 years. Follow ups will be initially after applying of the second study arm interventions, and then after 5 and after 9-10 years respecting baseline (T=0). The third study arm The third study arm is optional. It is related to additional positioning of endooseal implants (Other: Astra TECH Implant System or Ankylos Dentsply Friadent, DENTSPLY Implants Europa) in edentulous jaws – only the lower one, or only the upper ones, or the upper and the lower jaws, for selected patients. Procedure: Insertion of two screw type dental implants into jaw bone. Superstructure for these implants will be ball retainers for every solitary endooseal implant. The randomization process will follow subjective remarks and objections of a patients, as well as objective findings of the investigator-specialist of dental prosthetic and outcome accessor (expected number of a patients n=11). Randomization process will be ultimately by the presence or absence of osteopenia/osteoporosis in the jaws, bone quality, allergic propensity, and additional needs for local jaw-bone augmentation or other. Follow ups will be initially after applying of the third study arm interventions, and then after 9-10 years respecting baseline (T=0) i.e. at the end of this study. Patient satisfaction is assessed with the OHIP-EDENT questionnaire validated in Bosnian (Serbian version) language. |
| Intervention type | Mixed |
| Primary outcome measure | Oral health-related quality of life, assessed using the OHIP EDENT questionnaire at baseline, 90 days, 5 years and 9-10 years |
| Secondary outcome measures | Occlusal corrections measured using articulating paper immediately after the baseline, 1, 2, 3, 4, up to 9 months |
| Overall study start date | 01/09/2016 |
| Completion date | 01/09/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 129 |
| Total final enrolment | 117 |
| Key inclusion criteria | 1. Edentulous in both jaws 2. Complete denture wearers 3. Clinically acceptable occlusal relationships 4. Healthy mucosa (with no signs of inflammation, traumatic lesions, candidiasis, hyperplasia or tumors) |
| Key exclusion criteria | 1. Residual vertical bone height less than 10 mm 2. No attached mucosa in any region of mandible (type E) 3. Dentures with deteriorated intaglio surfaces 4. Dentures with large pre-existing fractures 5. Dentures with severely altered occlusal vertical dimension 6. Dentures with unsatisfactory occlusions 7. Neurological diseases 8. Lack of motor coordination 9. Difficulty of understanding instructions and the conditions of the study 10. Patients with residual roots, cysts or bone spicules 11. Patients with allergies to methyl methacrylate or silicone 12. Knife-edge mandibular ridges |
| Date of first enrolment | 01/04/2017 |
| Date of final enrolment | 23/04/2018 |
Locations
Countries of recruitment
- Bosnia and Herzegovina
Study participating centres
72270
Bosnia and Herzegovina
72000
Bosnia and Herzegovina
72250
Bosnia and Herzegovina
70230
Bosnia and Herzegovina
Sponsor information
Hospital/treatment centre
Slavka Gavrančića 17
Travnik
72270
Bosnia and Herzegovina
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | 01/09/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Stored in repository |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed dental Journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a publically available repository Preprint results in https://doi.org/10.21203/rs.3.rs-117922/v1 (added 02/03/2021) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 20/09/2020 | 04/03/2021 | Yes | No |
| Protocol file | 29/09/2022 | No | No | ||
| Results article | Psychometric properties of ohip-edent b&h for conventional complete denture wearers | 10/01/2023 | 23/01/2023 | Yes | No |
Additional files
Editorial Notes
23/01/2023: Publication reference added.
29/09/2022: Uploaded protocol (not peer-reviewed) as an additional file.
04/03/2021: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
02/03/2021: Preprint results link added to publication and dissemination plan.
