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New treatment option for Dental Implant
Official title Socket Reconstruction Technique and Immediate Implant Placement With Two Different Bone Substitute Materials.
ClinicalTrials.gov ID: NCT06517030
What this study is testing
- What it's testing
- The present research is a national multicentric prospective parallel double-blinded (both the patient and the examiner are blind) randomized controlled clinical trial. It is a superiority comparative study on a medical device CE (conformité européenne) marking, used according to the intended use subject to the CE marking.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 to 70. Healthy volunteers may be eligible.
You may be able to join if
- Participant is willing and able to give informed consent for participation in the trial.
- In good general health as evidenced by medical history.
- Presenting a single hopeless tooth candidate for extraction in the maxillary or mandibular area (from second premolar to second premolar...
- Presence of \>3mm of buccal wall dehiscence evaluated using Cone Beam Computed Tomography (CBCT).
- In healthy periodontal conditions (i.e., no presence of sites ≥ 4 mm and/or presence of intra-bony defects in the selected sites, full mouth plaque...
You likely can't join if
- Current or previous use of immunosuppressant, bisphosphonate, or high-dose corticosteroid therapy.
- Presence of inflammatory and autoimmune disease of the oral cavity.
- Severe or poorly controlled diabetes or previous radiotherapy of head area.
- Contraindications to dental and/or surgical interventions (e.g. severe endocrine bone diseases, severe metabolic bone disorders, malignant tumour...
- Individuals who are smokers of \>10 cigarettes/day.
- Female participant who is pregnant, lactating or planning pregnancy during the course of the study.
See the full eligibility criteria
- Participant is willing and able to give informed consent for participation in the trial.
- In good general health as evidenced by medical history.
- Presenting a single hopeless tooth candidate for extraction in the maxillary or mandibular area (from second premolar to second premolar, intercalated or the last tooth of dental arch) in need of a single...
- Presence of \>3mm of buccal wall dehiscence evaluated using Cone Beam Computed Tomography (CBCT).
- In healthy periodontal conditions (i.e., no presence of sites ≥ 4 mm and/or presence of intra-bony defects in the selected sites, full mouth plaque score \< 20% and full-mouth bleeding score \< 20%).
- Current or previous use of immunosuppressant, bisphosphonate, or high-dose corticosteroid therapy.
- Presence of inflammatory and autoimmune disease of the oral cavity.
- Severe or poorly controlled diabetes or previous radiotherapy of head area.
- Contraindications to dental and/or surgical interventions (e.g. severe endocrine bone diseases, severe metabolic bone disorders, malignant tumour diseases).
- Individuals who are smokers of \>10 cigarettes/day.
- Female participant who is pregnant, lactating or planning pregnancy during the course of the study.
- Presence of \<3mm of dehiscence of buccal walls of the socket after tooth extraction.
- Presence of a distance between the interdental bone crest and buccal bone crest \<3 mm after tooth extraction.
The study team makes the final eligibility decision.
Where it's taking place
- Milan, Mi, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years to 70 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Milan, Mi, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.