Alveolar Bone Loss Clinical Trial
Official title:
Influence Of Thickness Of the Peri-implant Soft Tissue On Marginal Bone Remodeling Around Bone Level Implant: A Multicenter Observational Clinical Study
The aim of this observational study is the evaluation of marginal bone remodeling after surgical implant placement, correlating the gingival thickness with the bone resorption rate.
The present study was designed as a multicenter prospective clinical trial. Five clinical
centers will treat patients through the placement of a single dental implant. The fixtures
will be prosthetic loaded three months after placement and will be acquired periapical
radiographs at each timepoint (base-two months-three-months-6 months-12 months). For every
inserted implants the experimental parameters will be collected for the following 2 years.
Surgical procedure. All patients will receive antibiotic prophylaxis with 2 g of amoxicillin
one hour before surgery. Crestal incision is performed under local anesthesia with articaine
4% with epinephrine, taking care to preserve the keratinized tissue. With the help of a
periosteal elevator, it will be set up carefully buccal flap total thickness, and the
vertical thickness of the soft tissue will be measured with a labeled probe every 1.0 mm. If
the vertical thickness of the soft tissue will be 2 mm or less, it will be considered thin.
If mucosal thickness will be greater than 2 mm, it will be considered thick. After
measurement, the lingual flap will be raised to full-thickness, and will be prepared the site
for implant placement. The implant site will be at least 1.5 mm from the tooth / teeth
adjacent, and must be surrounded by at least 1 mm of bone is buccal to lingual. With a
platform switching facility a millimeter will be placed below the level of the bone crest
with a one-stage approach as per the manufacturer's recommendations. After insertion, it will
be screwed a healing abutment, and the flaps will be sutured without tension with interrupted
sutures 4/0. Patients of both groups will be instructed to disinfect the site through a rinse
twice a day for a week for 1 minute with 0.12% chlorhexidine digluconate. Patients will be
advised to avoid chewing on the operated site and cleaning the healing abutments with an
ultra soft toothbrush. After 2 months of healing, it will be evaluated clinical stability and
the radiographic appearance of the plants. All plants will be rehabilitated by the
prosthetist with single screwed restorations. After the prosthetic treatment, patients will
receive oral hygiene instruction and will be monitored through calls to ensure periodontal
health (Bleeding on Probing <20% and Plaque Index <25%) throughout the study period.
Radiographic evaluation Intraoral radiographs will be captured in high-resolution mode with a
film, customized support from a jig polyvinylsiloxane, using the technique of parallel rays.
Intraoral radiographs will be acquired after implant placement (baseline-assessment of
inclusion fairness), after 2 months of healing (osseointegration rating), after insertion of
the crown (3 months-adaptation assessment of the restoration prosthetic), after 6 months
(early loading of evaluation) and after a year of recovery (of the medium-term load rating).
The number of intraoral radiographs will be the same which normally is carried out in the
course of an implant-prosthetic rehabilitation. The images will be obtained in such a way
that the implant-abutment interface is clearly visible. Measurements of bone level will be
performed by a blinded central reader using a dedicated program at 20 times magnification.
Before the calculation of the crestal bone changes, the RVG images will be calibrated with
the implant diameter. bone loss will be calculated by comparing the radiographs at baseline
with the radiographs obtained during follow-up visits. The system board and the first contact
radiographic bone-implant will be selected as reference points to calculate bone loss. The
average of the mesial and distal measurements will be recorded for each implant.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT05470673 -
Autogenous Demineralized Dentin Graft Combined With Injectable PRF + Metronidazole Versus Autogenous Demineralized Dentin Graft Alone for Alveolar Ridge Preservation
|
N/A | |
| Recruiting |
NCT02580721 -
The Influence of Mucosal Tissue Thickness on Soft and Hard Tissue Changes Around Implants
|
N/A | |
| Completed |
NCT02515058 -
Ridge Preservation Following Tooth Extraction Using Two Mineralized Cancellous Bone Allografts
|
N/A | |
| Enrolling by invitation |
NCT02209311 -
Effectiveness and Safety of Method of Maxilla Alveolar Process Reconstruction Using Synthetic Tricalcium Phosphate and Autologous MMSCs
|
Phase 1/Phase 2 | |
| Completed |
NCT02602223 -
Comparison of Amnion Chorion Membrane vs. Dense Polytetrafluoroethylene Membrane in Ridge Preservation Procedures
|
Phase 2 | |
| Completed |
NCT02255149 -
A Feasibility Study for Growth Bone Vertically With Titanium Mesh and Allograft in Lower Posterior Jaw
|
N/A | |
| Recruiting |
NCT06081296 -
Dimensional Changes in Alveolar Ridge Preservation
|
N/A | |
| Recruiting |
NCT05674331 -
Clinical, Radiographical, Histological Evaluation and Blood Flow Analysis of Alveolar Ridge Preservation
|
N/A | |
| Completed |
NCT03944811 -
Bone Height Gain Following Transcrestal Sinus Floor Elevation Using Piezoelectric Surgery Versus The Conventional Osteotome Technique
|
N/A | |
| Completed |
NCT03045458 -
Associations of Alveolar Bone Loss and Interleukin-1β Levels in One and Two Stage Surgical Procedures
|
N/A | |
| Completed |
NCT05595746 -
Radiological Bone Loss on Different Levels of Dental Implants
|
N/A | |
| Completed |
NCT03357705 -
Effectiveness in Limiting the Need to Elevate the Maxillary Sinus
|
N/A | |
| Recruiting |
NCT05311735 -
Mineralized and Partial Demineralized Dentin Graft Compared to FDBA
|
N/A | |
| Completed |
NCT05494476 -
Stability of the Marginal Bone Around Subcrestal Implants
|
N/A | |
| Not yet recruiting |
NCT05536479 -
Evaluation of Autogenous Stored Versus Autogenous Fresh Mineralized Dentin Graft for Alveolar Ridge Preservation
|
N/A | |
| Active, not recruiting |
NCT02275767 -
Histological Evaluation of Healing Following Ridge Preservation Using a Combined Cortical/Cancellous Mineralized Freeze-Dried Bone Allograft
|
N/A | |
| Active, not recruiting |
NCT02120053 -
Interest of Bone Substitute Material in Immediate Complete Denture
|
Phase 2/Phase 3 | |
| Completed |
NCT01728844 -
GUIDOR® Growth Factor Enhanced Bone Graft Substitute for the Treatment of Periodontal Defects 6-months Post-Surgery
|
N/A | |
| Terminated |
NCT00991965 -
Localized Alveolar Ridge Augmentation With Dental Implant
|
N/A | |
| Terminated |
NCT00991432 -
Localized Alveolar Ridge Augmentation With Space Maintenance Devices
|
N/A |