The success of a new dental implant in the jaw bone
| ISRCTN | ISRCTN15663606 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15663606 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | 103.22 |
| Sponsor | Straumann (Switzerland) |
| Funder | Straumann AG |
- Submission date
- 15/07/2022
- Registration date
- 20/08/2022
- Last edited
- 22/10/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
Long-term clinical and esthetic conservation of implants depends on the preservation of both the hard and soft tissues surrounding the implant. Some bone loss, which happens when teeth are lost, is to be expected: 1.5 to 2 mm during the first year of the implant’s functional life, and an annual loss of 0.2 mm thereafter. Diverse published articles argue that the design of the implant collar and implant surface characteristics are associated with reductions in marginal bone loss, a finding that has led to the development of new implants with diverse new configurations toward the crown of the tooth and topographic modifications aimed at improving bone (osseo) integration and conserving the health of the adjacent tissues. This study aims to evaluate the implantation of an arch of tooth implants in the upper maxilla jaw bone versus a transmucosal dental implant in the lower mandible jaw bone.
Who can participate?
Patients requiring single or multiple teeth replacements with dental implants
What does the study involve?
Replacement of missing teeth with tissue level implants and recording of clinical data, including the type of incision (flap versus flapless), and implant sites (healed versus post-extractive) on marginal bone loss, soft tissue parameters and implantation survival rate, at every follow-up visit.
What are the possible benefits and risks of participating?
The benefits are restoring the function and esthetics of missing teeth in a shorter time. The possible risks are missed osseointegration of the implants. In this case, the implant will be inserted again after 3 months.
Where is the study run from?
University of Rome Tor Verga (Italy)
When is the study starting and how long is it expected to run for?
March 2022 to May 2024
Who is funding the study?
Straumann AG (Italy)
Who is the main contact?
Dr Paolo Carosi (Italy)
paolo.carosi@alumni.uniroma2.eu
Contact information
Principal investigator
Via della Ricerca Scientifica 1
Rome
00133
Italy
| Phone | +39 3277998699 |
|---|---|
| paolo.carosi@alumni.uniroma2.eu |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Observational cohort study |
| Secondary study design | Cohort study |
| Study type | Participant information sheet |
| Scientific title | Clinical and radiological success of a novel dental implant with transmucosal implantation |
| Study objectives | To assess the potential effect of the implantation of a full arch (in the upper maxilla jaw bone versus the transmucosal dental implant in the lower mandible jaw bone), type of incision (flap versus flapless), and implant sites (healed versus post-extractive) on marginal bone loss (MBL), soft tissue parameters and implantation survival rate (ISR) |
| Ethics approval(s) |
Approved 14/06/2022, Ethical Committee of Policlinico Tor Vergata (Comitato Etico Indipendente Tor Vergata) (Viale Oxford 1, Rome, -, Italy; +39 06 2090 0035; comitato.etico@ptvonline.it), ref: 103.22 |
| Health condition(s) or problem(s) studied | Single or multiple teeth missing in both jaws |
| Intervention | Replacement of missing teeth with tissue level implants (TLX) and recording of clinical data at every follow-up visit. There will be no randomization. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
1. Implantation survival rate (ISR) measured during a control visit every 4 months. A surviving implant is an implant that maintains its function in the mouth. |
| Key secondary outcome measure(s) |
1. Initial implant stability quotient values (ISQ-0) and insertion torque at implant placement recorded at each scheduled visit every 4 months from implant placement |
| Completion date | 01/07/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 80 |
| Key inclusion criteria | 1. Aged 18 years old and over 2. Requiring a single or partial fixed implant prosthesis (FDP) of maxillary and mandibular arch 3. Otherwise healthy patients 4. Full mouth bleeding and full mouth plaque index lower than or equal to 25% 5. Bone height for at least 4 mm-long implants 6. Bone width of at least 3 mm and 4 mm 7. Fresh extraction sockets with an intact buccal wall |
| Key exclusion criteria | 1. Psychiatric contraindications 2. Pregnancy or nursing 3. Any interfering medication such as: 3.1. Steroid therapy 3.2. Bisphosphonate therapy 4. Alcohol or drug abuse 5. Heavy smoking (>10 cigarettes/day) 6. Radiation therapy to head or neck region within 5 years 7. Untreated periodontitis 8. Acute and chronic infections of the adjacent tissues or natural dentition 9. Severe maxillomandibular skeletal discrepancy 10. High and moderate parafunctional activity 11. Absence of opposite teeth |
| Date of first enrolment | 25/08/2022 |
| Date of final enrolment | 29/04/2023 |
Locations
Countries of recruitment
- Italy
Study participating centre
Rome
00133
Italy
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Dr Paolo Carosi, paolo.carosi@alumni.uniroma2.eu. Raw data from the study will be available upon request for 1 year after the study ends. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
22/10/2024: The following changes were made:
1. The overall study end date was changed from 31/12/2026 to 01/07/2024.
2. The recruitment start date was changed from 02/08/2022 to 25/08/2022.
3. The recruitment start date was changed from 31/07/2023 to 29/04/2023.
4. The intention to publish date was changed from 01/08/2027 to 30/12/2024.
29/07/2022: Trial's existence confirmed by sponsor Institut Straumann AG, which is funding the study.
