Study of loading different surface-modified dental implants at 6 weeks after insertion
| ISRCTN | ISRCTN13181677 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13181677 |
| Secondary identifying numbers | SLA-NH-SA |
- Submission date
- 28/02/2021
- Registration date
- 04/03/2021
- Last edited
- 28/04/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
Dental implants are small fixtures that are placed under the gum to work as the roots of a missing tooth. A crown or artificial tooth is then fitted to match the rest of the teeth. Various surface treatment options have been tested with the aim of improving the osseointegration (bone ingrowth) of dental implants, in order to reduce overall treatment time. The aim of this study is to investigate whether implant surface characteristics influence the osseointegration process, up to 6 weeks after dental implant insertion.
Who can participate?
Healthy patients with at least one missing tooth who do not require bone grafting
What does the study involve?
Patients are randomly allocated to one of three different surfaces for their dental implants. The study involves clinical and radiological examinations, dental implant placement, stability measurements immediately after implant placement and 6 weeks after surgery, prosthesis delivery 6 weeks after implant placement and peri-implant probing depth measurements 3 months after prosthesis delivery.
What are the possible benefits and risks of participating?
The benefits are getting an implant-supported prosthesis and with that getting back normal chewing function. The risks are the same as general dentoalveolar surgery as usual, such as soft or hard tissue injury, nerve injury, and bleeding during surgery.
Where is the study run from?
Semmelweis University (Hungary)
When is the study starting and how long is it expected to run for?
August 2019 to October 2020
Who is funding the study?
Semmelweis University (Hungary)
Who is the main contact?
Dr Kinga Körmöczi
kormoczi.kinga@dent.semmelweis-univ.hu
Contact information
Public
Mária Str 52
Budapest
1085
Hungary
| Phone | +36 (0)20982120 |
|---|---|
| kormoczi.kinga@dent.semmelweis-univ.hu |
Study information
| Study design | Randomized prospective clinical trial |
|---|---|
| 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 | The early loading of different surface-modified implants: a randomized clinical trial |
| Study objectives | The aim of this randomized controlled trial was to investigate whether the implant surface characteristics influence the osseointegration process, up to 6 weeks after dental implant insertion. |
| Ethics approval(s) | Approved 12/09/2019, National Institute of Pharmacy and Nutrition, Medical General Department, Medical Research Council Budapest (Zrínyi str 3. Budapest 1051; +36 (0)1 8869 329; amd@ogyei.gov.hu), ref: OGYÉI/55197/2019 |
| Health condition(s) or problem(s) studied | Patients with at least one missing tooth and requiring an implant-supported fixed partial denture |
| Intervention | A computer-generated randomization scheme is used to allocate patients to three different groups. Randomization codes are secured in an opaque envelope. An external assessor, not previously involved in the study, prepares all the envelopes. Patients are randomised to receive SA (alumina sandblasted and acid-etched), NH (bioabsorbable apatite nanocoating) or SLA (large-grit sandblasted and acid-etched) surface implants. The implant stability is measured at the time of implant placement (primary stability) and 6 weeks after prosthesis delivery (secondary stability). Osstell and Periotest are applied to take all the measurements. The primary and secondary stability are compared in the three study groups. Finally, the peri-implant probing depth appearing after 3 months of loading is checked on six points around to the implant-supported prostheses. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 1. Implant failure measured with clinical and radiological examinations 6 weeks after implant placement and 3 months after prosthesis delivery 2. Implant stability measured with Osstell and Periotest devices immediately after implant placement and 6 weeks after the surgery |
| Secondary outcome measures | Peri-implant probing depth measured with Williams-periodontal probe at 3 months after prosthesis delivery |
| Overall study start date | 01/08/2019 |
| Completion date | 01/10/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 60 |
| Total final enrolment | 53 |
| Key inclusion criteria | 1. Patients with an edentulous site requiring implant-supported fixed partial dentures 2. Good compliance 3. Good or moderate oral hygiene 4. Complete mucosal healing at the study site 5. Previous tooth extraction performed between 2 months and 1 year prior to implant placement |
| Key exclusion criteria | 1. General contraindications to oral surgery (i.e. non-controlled systematic diseases, chemo- and radiotherapy in the head and neck region, previous and ongoing bisphosphonate or denosumab therapy) 2. Incomplete mucosal healing at the study site 3. Need for bone grafting 4. Previous socket preservation or ridge augmentation 5. >5 mm of periodontal pockets at adjacent teeth 6. Poor oral hygiene 7. Smoking more than 10 cigarettes per day |
| Date of first enrolment | 07/10/2019 |
| Date of final enrolment | 12/12/2019 |
Locations
Countries of recruitment
- Hungary
Study participating centre
Mária str 52
Budapest
1085
Hungary
Sponsor information
University/education
Üllői str 26.
Budapest
1085
Hungary
| Phone | +36 (0)1 2660457 |
|---|---|
| titkarsag.arcallcsont@dent.semmelweis-univ.hu | |
| Website | http://semmelweis.hu/english/the-university/ |
"ROR" |
https://ror.org/01g9ty582 |
Funders
Funder type
University/education
Private sector organisation / Universities (academic only)
- Alternative name(s)
- Semmelweis University
- Location
- Hungary
Results and Publications
| Intention to publish date | 01/10/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in BMC Oral Health |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Kinga Körmöczi (kinga.kormoczi@gmail.com or kormoczi.kinga@dent.semmelweis-univ.hu) or Dr Árpád Joób-Fancsaly (joobarpad@gmail.com or joob_fancsaly.arpad@dent.semmelweis-univ.hu). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 26/04/2021 | 28/04/2021 | Yes | No |
Editorial Notes
28/04/2021: Publication reference added.
02/03/2021: Trial's existence confirmed by National Institute of Pharmacy and Nutrition, Medical General Department, Medical Research Council Budapest.
