A new dental implant in the aesthetic zone
| ISRCTN | ISRCTN76538898 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN76538898 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | 21/2022 |
| Sponsor | ITI International Team for Implantology |
| Funder | International Team for Implantology |
- Submission date
- 13/02/2022
- Registration date
- 19/02/2022
- Last edited
- 30/03/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
The aesthetic zone (also known as the smile zone) refers to all of the hard and soft tissues of the mouth that are visible when the patient makes a broad smile. Immediate loading in the aesthetic zone (the placement of a dental restoration within 48 hours of implant placement) is a well-documented technique. The technique relies on the stability of the positioned implants, which depends on the design of the implants and on the quality of the surrounding bone. This study aims to assess the performance of a new dental implant placed in the anterior (front) zone of both jaws and loaded with a restoration immediately.
Who can participate?
Patients aged 18 years and over with a single tooth missing in the aesthetic zone
What does the study involve?
The missing tooth is replaced with a dental implant. After the healing period, a crown is placed. Patients are recalled every 4 months for professional oral hygiene and at 12 months for an x-ray and clinical examination.
What are the possible benefits and risks of participating?
The benefit of the study is that the positioned implants are loaded immediately and immediately restored in a single rehabilitation center.
Where is the study run from?
University of Rome La Sapienza (Italy)
When is the study starting and how long is it expected to run for?
October 2018 to December 2021
Who is funding the study?
International Team for Implantology (Switzerland)
Who is the main contact?
Dr Paolo Carosi
paolo.carosi@alumni.uniroma2.eu
Contact information
Principal investigator
Via Montpellier 1
Rome
00133
Italy
 ORCID ID |
0000-0002-2442-1091 |
|---|---|
| Phone | +39 (0)3277998699 |
| paolo.carosi@alumni.uniroma2.eu |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Retrospective observational study |
| Secondary study design | Cohort study |
| Study type | Participant information sheet |
| Scientific title | Clinical and radiographic performance of immediately temporized BLX implants in the aesthetic zone: a retrospective single-cohort study |
| Study acronym | BLX ESTH |
| Study objectives | The aims of this patient single-cohort study are: 1. To evaluate the 1-year clinical and radiographic performance of immediately temporized implants with novel macrodesign placed in the anterior zone 2. To investigate the contribution of site characteristics and surgical protocol on primary stability |
| Ethics approval(s) | Approved 01/02/2022, the institutional review board of La Sapienza University of Rome (Viale del Policlinico 155, Rome, Italy; +39 (0)649979822; comitato.etico@policlinicoumberto1.it), ref: 21/2022 |
| Health condition(s) or problem(s) studied | Rehabilitation of a single tooth in the aesthetic zone by means of one implant with immediate restoration |
| Intervention | The missing tooth is replaced with a Straumann BLX in the aesthetic zone. After the healing period, a screw-retained zirconia-based single crown is realized and delivered to the patient. Patients are followed up for 1 year after definitive prosthesis delivery and radiographic and periodontal values were recorded. Patients are recalled every 4 months for professional oral hygiene and at 12 months for the annual radiographic and clinical examination. |
| Intervention type | Device |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure(s) |
1. Radiographic marginal bone loss (MBL) assessed using standardized intraoral digital periapical radiographs with the parallel technique by means of customized periapical radiograph holder (Rinn, DentsplySirona, York, PA, USA) at definitive prosthesis placement (baseline) and after 1 year |
| Key secondary outcome measure(s) |
Effects of implant location, flap design and implant timing on insertion torque and implant stability quotient (ISQ) values, recorded by Osstell implant stability recording at implant placement |
| Completion date | 31/12/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 34 |
| Total final enrolment | 60 |
| Key inclusion criteria | 1. At least 18 years old 2. Systemic health recorded as a ASA 1 or ASA II diagnosis following the definition of the American Society of Anesthesiologists 3. Full mouth bleeding index and full mouth plaque index lower than or equal to 25% at baseline 4. One permanent missing tooth or failing tooth in the anterior zone of either arch 5. Patient desire to have the edentulous site or hopeless tooth treated with a single implant-supported fixed dental prosthesis (FDP) intact buccal socket wall evaluated at the time of the extraction 6. Adequate bone quantity to place an implant with a diameter of at least 3.5 mm and a length of at least 10 mm |
| Key exclusion criteria | 1. General medical (ASA III or IV) and/or psychiatric contraindications to oral surgery 2. Pregnancy or nursing 3. Steroid therapy or 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 12. Unavailability to attend regular follow-up visits |
| Date of first enrolment | 01/10/2018 |
| Date of final enrolment | 25/03/2019 |
Locations
Countries of recruitment
- Italy
Study participating centre
Rome
00161
Italy
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The participant data are available on request from the principal investigator Paolo Carosi (paolo.carosi@alumni.uniroma2.eu) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 06/01/2023 | 30/03/2023 | Yes | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
30/03/2023: Publication reference added.
17/02/2022: Trial's existence confirmed by the institutional review board of La Sapienza University of Rome.
