Prosthetic Modality and MBL
ConditionBone Loss
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorStudio Odontoiatrico Associato Dr. P. Cicchese e L. Canullo
About this trial
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
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Any bone augmentation performed on the implant site with a healing period of less than 3 months.
Local inflammation (including untreated periodontitis).
Mucosa disease such as erosive lichen planus
Trial design
Design model
Parallel
Treatments tested in this trial
Traditional prosthetic procedure
Procedure/SurgeryThree months later, after an impression, haling abutment will be removed and a screw-retained restoration will be seated using a Ti-Base abutment.
one abutment-one time
Procedure/SurgeryThree months later, after an impression, a screw-retained restoration will be seated directly on the connect healing
Treatment groups
60 Participants
are divided into 3 treatment groupsGroup A: Arm 1Active comparator 1 intervention
Group B: Arm 2Experimental treatment 1 intervention
Group C: Arm 3Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
MBL
magical bone level changes will be measured through X-rays
Time frame
one year post surgerySecondary outcomes
1
peri-implant soft tissue variables
BoP
Time frame
one year post surgery2
peri-implant soft tissue variables
Pi
Time frame
one year post surgery3
peri-implant soft tissue variables
PD
Time frame
one year post surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Studio Odontoiatrico Associato Dr. P. Cicchese e L. Canullo
Lead sponsor
Alessio Triestino
Collaborator
Source ClinicalTrials.gov