| NCT ID | NCT07156110 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Studio Odontoiatrico Associato Dr. P. Cicchese e L. Canullo |
| Condition | Bone Loss |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-09-01 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2025-09-01 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The present study will test the effect of different prosthetic modalities on conical and internal hex connection implants, assessing the radiographic MBL changes after one year. Consecutive patients fulfilling inclusion/exclusion criteria will enter the study. Once the implant is inserted, patients will be divided into three groups according to the time if their inclusion in the study. Study groups (20 patients per group): 1. Group 1: Placing Lance Conical implant with a healing abutment. Three months later, after an impression, a screw-retained restoration will be seated using a Ti-Base abutment. 2. Group 2: Placing Lance+ (Internal Hex connection) implant with a healing abutment. Three months later, after an impression, a screw-retained restoration will be seated using a Ti-Base abutment. 3. Group 3: Placing Lance Conical implant together with Connect Abutment (tightened to 30 Ncm) with a Connect healing cap ("one time one abutment"). Screw retained restoration after 3 months. Consecutive inclusion of patients - 1st- group 1, 2nd - group 2, 3rd - group 3 and vice versa. Primary outcome variable: bone level changes 12 months post-loading
Eligibility Criteria
Inclusion criteria: 1. Male or female ≥18 years old. 2. One or more adjacent missing teeth in the posterior maxilla or mandible (positions 4-7). A natural tooth had to be present at the mesial end; however, free-end situations were allowed. 3. Adequate bone quality )D1-3) and availability for Lance Conical implant (MIS Implants, Israel) placement of diameters 3.75 mm or 4.2 mm, length 10-13 mm, 4. Patients are willing to participate and attend the planned follow-up visits. Systemic exclusion criteria: 1. Medical conditions requiring prolonged use of steroids and/or medications that can interfere with bone metabolism. 2. History of leukocyte dysfunction and deficiencies. 3. History of neoplastic disease requiring the use of radiation or chemotherapy. 4. History of renal failure. 5. Metabolic disorders such as osteoporosis. 6. History of uncontrolled endocrine disorders. 7. Physical handicaps that would interfere with the ability to perform adequate oral hygiene. 8. Use any investigational drug or device within 30 days immediately before implant surgery. 9. Alcoholism or any drug abuse. 10. History of immunodeficiency syndromes. 11. Smokers of 10 cigarettes per day, cigar equivalents, or tobacco chewers. 12. In the investigator's opinion, conditions or circumstances would prevent completion of study participation or interfere with the analysis of the study results, such as history of non-compliance or unreliability. Local exclusion criteria 1. Any bone augmentation performed on the implant site with a healing period of less than 3 months. 2. Local inflammation (including untreated periodontitis). 3. Mucosa disease such as erosive lichen planus 4. History of local irradiation therapy. 5. Presence of osseous lesions 6. History of implant failure 7. Postextraction sites with less than 6 weeks of healing 8. Sever bruxism or cjenching habits 9. Persistent intraoral infection. 10. Bone type 4. Exclusion criteria at surgery 1. Lack of primary stability less than 35 Ncm. 2. Need for augmentation procedures during implant surgery. 3. Inability to place the implant according to the prosthetic requirements.
Contact & Investigator
luigi Canullo, prof
PRINCIPAL INVESTIGATOR
Studi Odontoiatrici Canullo
Frequently Asked Questions
Who can join the NCT07156110 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Bone Loss. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07156110 currently recruiting?
Yes, NCT07156110 is actively recruiting participants. Contact the research team at luigi.canullo@gmail.com for enrollment information.
Where is the NCT07156110 trial being conducted?
This trial is being conducted at Roma, Italy.
Who is sponsoring the NCT07156110 clinical trial?
NCT07156110 is sponsored by Studio Odontoiatrico Associato Dr. P. Cicchese e L. Canullo. The principal investigator is luigi Canullo, prof at Studi Odontoiatrici Canullo. The trial plans to enroll 60 participants.