Partial Edentulism in the Maxilla or in the MandibleNCT07041294
Comparing 7 mm and 5 mm Implants Placed Immediately After Molar Extraction
A study testing 7 mm Diameter Dental Implant and 5 mm Diameter Dental Implant in people with Partial Edentulism in the Maxilla or in the Mandible and Immediate Implant Placement, run by Marco Esposito at 1 site in Albania.
Trial summary
This clinical study aims to evaluate the performance and long-term outcomes of immediate dental implants placed in molar sites after tooth extraction. Eligible patients will receive one implant and a single crown in a posterior area (first or second molar). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Partial Edentulism in the Maxilla or in the Mandible, Immediate Implant Placement
- What is being tested?
- 7 mm Diameter Dental Implant and 5 mm Diameter Dental Implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteAlbania
- Study dates
- 1 Oct 2021to 1 Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- at least 18 years old
- able to sign an informed consent form
- requiring at least one immediate post-extractive implant in first and/or second molar sites
- sufficient bone to allow placement of an immediate implant at least 7 mm in length and 7 mm in diameter
Who cannot join
- general contraindications to implant surgery
- immunosuppressed or immunocompromised
- irradiation in the head or neck area
- uncontrolled diabetes
- pregnancy or lactation
- untreated periodontitis
Show all 16Show fewer
- poor oral hygiene and motivation
- addiction to alcohol or drugs
- psychiatric disorders
- unrealistic expectations
- acute infection (abscess) in the site intended for implant placement
- necessity to lift the maxillary sinus epithelium
- unable to commit to 5-year follow-up post-loading
- under treatment or had previous treatment with intravenous amino-bisphosphonates
- lack of bony wall completely surrounding the future implant
- participation in other studies interfering with present protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 7 mm Versus 5 mm Diameter Immediate Post-Extractive Implants in the Molar Region: A Multicentre Randomised Controlled Trial
This clinical study aims to evaluate the performance and long-term outcomes of immediate dental implants placed in molar sites after tooth extraction. Eligible patients will receive one implant and a single crown in a posterior area (first or second molar). The study will compare implant and crown success over a five-year period, tracking complications, bone changes, aesthetics, and patient satisfaction. Participants must be at least 18 years old and have sufficient bone to allow immediate implant placement. This research will provide important data on the safety and reliability of immediate implants in posterior areas.
Read the detailed description
This multicentre randomised controlled trial aims to compare the clinical outcomes of 7 mm versus 5 mm diameter dental implants placed immediately after tooth extraction in the molar region. The goal is to assess whether wider diameter implants offer any advantages in terms of implant survival, complications, bone preservation, and patient satisfaction, when placed in fresh extraction sockets.
A total of 70 patients requiring molar tooth extraction and immediate implant placement will be enrolled across 7 centers. Each participant will receive either a 5 mm or a 7 mm diameter implant, allocated randomly. Standardised surgical and prosthetic protocols will be followed.
Follow-up visits will assess implant stability, radiographic bone changes, and clinical outcomes over time. Patient-reported outcomes and complications will also be recorded to compare the two groups. Results will be reported at 1 and 5 years after loading.
This study may help clinicians make evidence-based decisions when choosing the diameter of implants in molar regions, particularly in immediate post-extraction situations.
- Being tested
- 7 mm Diameter Dental Implant, 5 mm Diameter Dental Implant
- Keywords
- Deantal implant, Immediate implant, Post-extraction implant, Wide diameter implant, Follow-up
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
7 mm Diameter Dental ImplantDevice
To evaluate immediate post-extraction implants with different diameters (7 vs. 5 mm)
5 mm Diameter Dental ImplantDevice
To evaluate immediate post-extraction implants with different diameters (5 vs. 7 mm)
| Study group | Role | What they receive |
|---|---|---|
| 7 mm Diameter Implant | Experimental | Participants receive a 7 mm diameter implant placed immediately after molar extraction. Receives: Device: 7 mm Diameter Dental Implant |
| 5 mm Diameter Implant | Active comparator | Participants receive a 5 mm diameter implant placed immediately after molar extraction. Receives: Device: 5 mm Diameter Dental Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of failed crowns (not placed or remade due to implant/prosthetic failure)
whether it will not be possible to place the crown because of implant failure or secondary to implant failure, or crown that has to be remade for any reason.
Measured: From implant placement to 5 years after loading.
Number of failed implants (implant mobility, infection, or mechanical complications)
Implant failure is defined as implant mobility and/or any infection dictating implant removal, and or/any mechanical problems rendering the implant unusable. The stability of each individual implant will be measured by the independent and blinded outcome assessor manually with a reverse torque of 20 Ncm at abutment connection and at delivery of the definitive crown, or by assessing the stability of the crown, using the handles of two metallic instruments, at 1 and 5 years after loading.
Measured: From implant placement to 5 years post loading.
Biological and biomechanical complications
Biological and biomechanical complications will be recorded and reported by study group. Examples of biological complications are: fistula, peri-implantitis. Examples of biomechanical complications are fracture of the metal screws, loosening of the crown, fracture of ceramic.
Measured: From implant placement to 5 years after loading.
Secondary outcomes (3)
Peri-implant marginal bone level changes
Digital intraoral periapical radiographs will be made with the paralleling technique at implant placement, implant loading, 1 and 5 years after loading. In case of unreadable radiograph, the radiograph has to be made again. Radiographs will be converted to TIFF format with a 600 dpi resolution, and stored in a personal computer. Peri-implant marginal bone levels will be measured using the Scion Image (Scion Corporation, Frederick, MD, USA) software. The software will be calibrated for every single image using the known implant length or the diameter of the implant collar. Measurements of the mesial and distal bone crest level adjacent to each implant will be made to the nearest 0.01 mm. Reference points for the linear measurements will be: the coronal margin of the implant collar and the most coronal point of bone-to-implant contact. Bone levels will be measured at both mesial and distal sides and averaged. Bone level at single implants will b
Measured: From implant placement to 5 years after loading.
Aesthetic evaluation
Aesthetic evaluation of the clinical pictures, taken at delivery of the final restorations, 1 and 5 years follow-ups, on a computer screen by an independent blinded dentist. The pictures of the vestibular and occlusal aspects have to include the 2 adjacent teeth, when present. The aesthetic evaluation will be done following the pink aesthetic score(1).
Measured: From implant placement to 5 years after loading.
Patient satisfaction
At the delivery of the final restorations, 1 and 5 years follow-up the independent outcome assessor at each centre will ask to the patient the following questions:
- Are you satisfied with the function of your implant supported tooth? Possible answers: yes absolutely, yes partly, not sure, not really, absolutely not.
- Are you satisfied with the aesthetic outcome of your implant supported tooth? Possible answers: yes absolutely, yes partly, not sure, not really, absolutely not.
- Would you undergo the same therapy again? Possible answers: "yes" or "no".
Measured: From implant placement to 5 years after loading.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2025
- Study start1 Oct 2021
- Primary completion15 May 2025
- Study completion1 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Partial Edentulism in the Maxilla or in the MandibleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marco Esposito
- Sponsor type
- Research network
- Responsible party
- Sponsor-investigator, Marco Esposito, Marco Esposito
- Investigators
- Marco Esposito, Dentistry, Principal investigator, IRCCS San Raffaele Scientific Institute and Vita-Salute San Raffaele University, Milan, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07041294
- Sponsor's protocol ID
- NR430PROT
- Status last verified
- Jul 2025
- First submitted
- 18 Jun 2025
- Last updated
- 8 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Furhauser R, Florescu D, Benesch T, Haas R, Mailath G, Watzek G. Evaluation of soft tissue around single-tooth implant crowns: the pink esthetic score. Clin Oral Implants Res. 2005 Dec;16(6):639-44. doi: 10.1111/j.1600-0501.2005.01193.x.
PubMed 16307569
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 7 mm Versus 5 mm Diameter Immediate Post-Extractive Implants in the Molar Region: A Multicentre Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07041294
- Acronym / sponsor ID
- NR430PROT
- Keywords
- Deantal implant, Immediate implant, Post-extraction implant, Wide diameter implant, Follow-up
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Marco EspositoResearch network
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 15 May 2025 (actual)
- Study completion
- 1 Jun 2029 (estimated)
- First posted
- 27 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical study aims to evaluate the performance and long-term outcomes of immediate dental implants placed in molar sites after tooth extraction. Eligible patients will receive one implant and a single crown in a posterior area (first or second molar). The study will compare implant and crown success over a five-year period, tracking complications, bone changes, aesthetics, and patient satisfaction. Participants must be at least 18 years old and have sufficient bone to allow immediate implant placement. This research will provide important data on the safety and reliability of immediate implants in posterior areas.
Detailed description
This multicentre randomised controlled trial aims to compare the clinical outcomes of 7 mm versus 5 mm diameter dental implants placed immediately after tooth extraction in the molar region. The goal is to assess whether wider diameter implants offer any advantages in terms of implant survival, complications, bone preservation, and patient satisfaction, when placed in fresh extraction sockets.
A total of 70 patients requiring molar tooth extraction and immediate implant placement will be enrolled across 7 centers. Each participant will receive either a 5 mm or a 7 mm diameter implant, allocated randomly. Standardised surgical and prosthetic protocols will be followed.
Follow-up visits will assess implant stability, radiographic bone changes, and clinical outcomes over time. Patient-reported outcomes and complications will also be recorded to compare the two groups. Results will be reported at 1 and 5 years after loading.
This study may help clinicians make evidence-based decisions when choosing the diameter of implants in molar regions, particularly in immediate post-extraction situations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 7 mm Diameter Implant | Experimental | Device: 7 mm Diameter Dental ImplantParticipants receive a 7 mm diameter implant placed immediately after molar extraction. |
| 5 mm Diameter Implant | Active comparator | Device: 5 mm Diameter Dental ImplantParticipants receive a 5 mm diameter implant placed immediately after molar extraction. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- at least 18 years old
- able to sign an informed consent form
- requiring at least one immediate post-extractive implant in first and/or second molar sites
- sufficient bone to allow placement of an immediate implant at least 7 mm in length and 7 mm in diameter
Key exclusion criteria (16 listed)
- general contraindications to implant surgery
- immunosuppressed or immunocompromised
- irradiation in the head or neck area
- uncontrolled diabetes
- pregnancy or lactation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 7 mm Diameter Dental ImplantTo evaluate immediate post-extraction implants with different diameters (7 vs. 5 mm) | Device | 7 mm Diameter Implant |
| 5 mm Diameter Dental ImplantTo evaluate immediate post-extraction implants with different diameters (5 vs. 7 mm) | Device | 5 mm Diameter Implant |
Primary outcome
Number of failed crowns (not placed or remade due to implant/prosthetic failure)
Time frame: From implant placement to 5 years after loading.
whether it will not be possible to place the crown because of implant failure or secondary to implant failure, or crown that has to be remade for any reason.
Number of failed implants (implant mobility, infection, or mechanical complications)
Time frame: From implant placement to 5 years post loading.
Implant failure is defined as implant mobility and/or any infection dictating implant removal, and or/any mechanical problems rendering the implant unusable. The stability of each individual implant will be measured by the independent and blinded outcome assessor manually with a reverse torque of 20 Ncm at abutment connection and at delivery of the definitive crown, or by assessing the stability of the crown, using the handles of two metallic instruments, at 1 and 5 years after loading.
Biological and biomechanical complications
Time frame: From implant placement to 5 years after loading.
Biological and biomechanical complications will be recorded and reported by study group. Examples of biological complications are: fistula, peri-implantitis. Examples of biomechanical complications are fracture of the metal screws, loosening of the crown, fracture of ceramic.
3 secondary outcomes
Peri-implant marginal bone level changes
Time frame: From implant placement to 5 years after loading.
Aesthetic evaluation
Time frame: From implant placement to 5 years after loading.
Patient satisfaction
Time frame: From implant placement to 5 years after loading.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
- Results publication: PubMed 16307569Furhauser R, Florescu D, Benesch T, Haas R, Mailath G, Watzek G. Evaluation of soft tissue around single-tooth implant crowns: the pink esthetic score. Clin Oral Implants Res. 2005 Dec;16(6):639-44. doi: 10.1111/j.1600-0501.2005.01193.x.
Related trials for Partial Edentulism in the Maxilla or in the Mandible
Active, not recruiting
Evaluation of Autogenous Bone Graft on Immediate Dental Implant Osseointegration Using Piezosurgery
Tooth Loss, Partial Edentulism in the Maxilla or in the Mandible
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marco Esposito, Dentistry principal investigator
IRCCS San Raffaele Scientific Institute and Vita-Salute San Raffaele University, Milan, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 7 mm Diameter Dental Implant and 5 mm Diameter Dental Implant in people with Partial Edentulism in the Maxilla or in the Mandible and Immediate Implant Placement, run by Marco Esposito at 1 site in Albania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Albania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of failed crowns (not placed or remade due to implant/prosthetic failure) (time frame: From implant placement to 5 years after loading.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07041294, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2025.