Conventional implants vs mini implants used to retain full lower dentures
| ISRCTN | ISRCTN87342238 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN87342238 |
| Secondary identifying numbers | 14653 |
- Submission date
- 05/07/2013
- Registration date
- 05/07/2013
- Last edited
- 17/02/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
There are 3.7 million people in Britain who have no natural teeth and most are over 65. Many of these individuals have difficulty wearing lower dentures, which causes difficulties in chewing and speaking resulting in a significant impact on quality of life, so much so that the World Health Organisation classifies these individuals as having a disability. Titanium implants screwed into the jaw hold lower dentures in place. Mini-implants have recently been developed. They are smaller and cheaper than traditional implants and are less painful to place. However, the long-term costs and benefits of mini-implants have not been compared with traditional implants. We will therefore undertake an initial study to compare mini-implants with traditional implants.
Who can participate?
Patients lacking teeth, who are referred to Manchester University Dental Hospital and meet the eligibility criteria will be able to take part.
What does the study involve?
After some initial tests patients will be randomly assigned to receive either mini or traditional implants. An appointment will be made for these to be fitted and the patients will also attend 1 week, 2 months & 6 months after surgery in order to make further assessments. Patients will need to complete a chewing test and questionnaires at these visits. Patients who receive the mini implants may find the surgery less painful but it is possible the implants may not be as long lasting. After the study the outcomes in the 2 groups will be analysed. The initial study will also tell us how quickly we can recruit patients and how many will stay once they have been recruited. The study will also help us build a team and give information on how to effectively manage a large-scale study.
What are the possible benefits and risks of participating?
Placing both types of implants requires a minor operation. The operation for the traditional implant is more extensive and may produce more pain and swelling. Any surgical procedure has risks of bleeding and infection. There is also a small risk of nerve damage or jaw fracture. Once it has been decided which implant you will receive the surgical team will discuss the procedure and potential side effects with you in greater detail. If you receive the mini implants you may find the operation easier to undergo but as the implants are smaller there is a chance that they might not be as long-lasting. Participating in the study does not require you to attend any additional appointments but appointments may take a little longer as we need to measure how well you can chew and you will need to complete several questionnaires. In total it may take 20 to 30 minutes to complete questionnaires at each visit, plus a few minutes for the chewing test. If you dont want to spend the extra time doing these tests you do not have to take part in the study.
Where is the study run from?
Manchester University Dental Hospital (UDHM) (UK)
When is study starting and how long is it expected to run for?
Patient recruitment is planned to start in September 2013 and will take place over one year.
Who is funding the study?
The study is funded by the National Institute of Health Research (NIHR), UK (Research for Patient Benefit funding stream), with the supply of mini implants funded by the manufacturer (3M).
Who is the main contact?
Helen Flight
helen.flight@christie.nhs.uk
Contact information
Scientific
550 Wilmslow Road
Manchester
M20 4BX
United Kingdom
| Phone | +44 (0)161 446 3000 |
|---|---|
| helen.flight@christie.nhs.uk |
Study information
| Study design | Randomised; Interventional; Design type: Not specified, Treatment |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | A pilot randomised controlled trial of Conventional Implants vs Mini Implants used to retain full lower DENTures |
| Study acronym | CIMI DENT |
| Study objectives | Titanium implants screwed into the jaw hold lower dentures in place, but implants are costly and require surgery that some patients may not cope with. Mini-implants have recently been developed; they are smaller and cheaper than conventional implants and are much less traumatic to place. However, the long-term costs and benefits of mini-implants have not been compared with conventional implants in high quality clinical trials. This pilot trial will gather the necessary information to inform a future large scale trial of conventional versus mini implants. |
| Ethics approval(s) | 13/NW/0384 |
| Health condition(s) or problem(s) studied | Topic: Oral and Gastrointestinal; Subtopic: Oral and Gastrointestinal (all Subtopics); Disease: Oral & Dental |
| Intervention | 1. Conventional dental implant (Astra) 2. Mini Dental Implant (3M) |
| Intervention type | Other |
| Primary outcome measure | Inform a large randomised trial of conventional vs mini implants; Timepoint(s): Throughout conduct of the pilot trial, each patient is followed-up for 6 months post surgery. |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/11/2013 |
| Completion date | 30/11/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 44; UK Sample Size: 44 |
| Key inclusion criteria | 1. Patient has been edentulous (no teeth at all) for at least 12 months 2. Bone height = 10mm in the interforamina region (anterior section of the mandible), therefore suitable for implant placement without bone grafting 3. Cawood and Howell Classification V and VI (severely resorbed mandible) 4. New lower denture remains unsatisfactory 5. Able to give informed consent to participate in the study 6. Aged 18 or over Target Gender: Male & Female ; Lower Age Limit 18 years |
| Key exclusion criteria | 1. Radiographic confirmation that the patient has insufficient mandibular bone for either procedure 2. Significant medical history contraindicating the placement of either conventional or miniimplants (e.g. bisphosphonate treatment, radiotherapy treatment, poorly controlled diabetes, longterm steriod use) 3. Current smoker, or have smoked in last six months 4. Unable to maintain adequate level of oral hygiene 5. Requires sedation for dental treatment 6. Previous failed implant treatment 7. Allergic to or unable to tolerate any of the ingredients of gummy jelly (an outcome measure) |
| Date of first enrolment | 01/11/2013 |
| Date of final enrolment | 30/11/2014 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
M20 4BX
United Kingdom
Sponsor information
Hospital/treatment centre
Genetic Medicine
Manchester Royal Infirmary
Oxford Road
Manchester
M13 9WL
England
United Kingdom
"ROR" |
https://ror.org/00he80998 |
|---|
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 15/02/2017 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
17/02/2017: Publication reference added.
