An interventional study of Implant insertion in Dental Implantation and Bone Remodeling, sponsored by Saint-Joseph University. Status unknown at 1 site in Lebanon. Open to participants aged 20 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-10-23.
Sponsored by Saint-Joseph University · Not applicable, Interventional, and Treatment
The aim of this prospective controlled clinical trial is to evaluate the clinical and radiographical outcomes of two implant surfaces inserted in a crest that has been horizontally augmented at least 6 months prior to the implant placement. The horizontal GBR should be done with a xenogenic graft mixed with autologous bone particles, and a collagen membrane stabilized using tacks or screws.
This is a prospective, randomized clinical and radiographical evaluation of bone remodeling around implants with two different surfaces placed in a previously augmented crest.
Patients requiring dental implants in previously horizontally augmented bone crest are recruited at the Department of Periodon¬tics, Faculty of dental medicine, Saint-Joseph University, Beirut, and will be treated with either T3 (contemporary hybrid collar), tapered, ex-hex, CP4 or Full Osseotite, tapered, ex-hex, CP4.
A total of 30 implants will be placed (15 per group). Random allocation of implant type per site will be done by the sealed envelope method.
The implants will be placed using a one-stage surgical approach. A final crown will be placed (screw-retained on multiunit abutment) between 3 and 4 months post-implant placement.
The patients will be followed-up at 6 months and 1 year. Only patients meeting inclusion/exclusion criteria and providing a dated and signed informed consent form will be enrolled in the study.
Saint-Joseph University is the lead sponsor of 71 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
External hexagone implant connection
Device: Implant insertion
Internal implant connection
Device: Implant insertion
In both groups, the implants will be placed using a two-stage surgical approach at the crestal level in previously horizontally augmented bony sites. A final crown will be placed (screw-retained on multiunit abutment) between 3- and 4-months post-implant placement. Random allocation of implant type per site will be done by the sealed envelope method. Follow-up measurements will be done at 6 months and 1-year post-loading. The measurements are done by a blinded investigator. Before starting the study, the examiner will be trained in a calibration process. Exam sheets are kept confidential and anonymous. Inclusion criteria are: patient aged 20 to 65, no systematic contraindication for implant surgery, smoking \< 10 cigarettes, previous horizontal bone augmentation, FMBS \<20% and FMPS \< 20%. Exclusion criteria are: general contraindication for implant surgery, pregnant/lactating women, uncontrolled diabetics, patients not willing to sign the consent form, active periodontitis.
Also known as: Radiological bone level
Change from baseline of alveolar ridge thickness at 4 months
Peroperative surgical measurements of the alveolar ridge width at implant sites
Time frame: During procedure and at 4 months
Change from baseline of radiographic bone level on CBCT at 1 year post-op
CBCT for buccal bone thickness measurements of the bone crest width at the implant site.
Time frame: During procedure and at 1 year
Change from baseline of radiographic bone level assessment at 1 year post-op, on periapical x-ray
Radiographic measurements on standardized periapical radiograph of the bone dimensions, for interproximal bone remodeling, from the shoulder of the implant (reference point), to the coronal bone to implant contact
Time frame: During procedure, at 4 months, at 6 months and 1 year
Change from baseline of bone plate thickness at 4 months
Peroperative buccal and lingual residual bone thickness following implant insertion
Time frame: During procedure and at 4 months
Insertion torque
Manual torque insertion are registered at implant placement.
Time frame: During procedure
Change of Clinical parameters from baseline to 1 year post-op
FMBS, FMPS,
Time frame: During procedure, at 6 months and at 1 year
Change of FMBS parameters from baseline to 1 year post-op
Change in full mouth bleeding score
Time frame: During procedure, at 6 months and at 1 year
Change of Keratinized tissue height from Baseline to 4 months
Measured using a 1.0-mm marked periodontal probe
Time frame: During procedure and at 4 months
Histological analysis
Bone core taken with a 2mm trephine bur at the site of implant placement for non-demineralized histological assessment of regenerated bone quality
Time frame: During procedure
Change of FMPS parameters from baseline to 1 year post-op
Change in full mouth plaque score
Time frame: During procedure, at 6 months and at 1 year
Plan to share: Yes — The outcome measurements and patients characteristics might be shared
Supporting information: Study protocol, Icf, Csr
This study is status unknown, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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Saint-Joseph University