An interventional study of 7 mm Diameter Dental Implant and 5 mm Diameter Dental Implant in Partial Edentulism in the Maxilla or in the Mandible and Immediate Implant Placement, sponsored by Marco Esposito. Active, not recruiting at 1 site in Albania. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-08.
Sponsored by Marco Esposito · Not applicable, Interventional, and Treatment
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.
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.
Marco Esposito is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive a 7 mm diameter implant placed immediately after molar extraction.
Device: 7 mm Diameter Dental Implant
Participants receive a 5 mm diameter implant placed immediately after molar extraction.
Device: 5 mm Diameter Dental Implant
To evaluate immediate post-extraction implants with different diameters (7 vs. 5 mm)
To evaluate immediate post-extraction implants with different diameters (5 vs. 7 mm)
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.
Time frame: 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.
Time frame: 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.
Time frame: From implant placement to 5 years after loading.
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
Time frame: 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).
Time frame: 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: 1. Are you satisfied with the function of your implant supported tooth? Possible answers: yes absolutely, yes partly, not sure, not really, absolutely not. 2. Are you satisfied with the aesthetic outcome of your implant supported tooth? Possible answers: yes absolutely, yes partly, not sure, not really, absolutely not. 3. Would you undergo the same therapy again? Possible answers: "yes" or "no".
Time frame: From implant placement to 5 years after loading.
This study is active, not recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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Marco Esposito