Bone Remodeling, Dental Implantation
Conditions
Keywords
Alveolar ridge augmentation, Dental implants, Marginal bone remodeling
Brief summary
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.
Detailed description
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.
Interventions
DEVICEImplant 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.
Sponsors
Saint-Joseph University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patient age: between 20 and 65 * No systematic contraindication for implant surgery * No more than 10 cigarettes/day * Previous horizontal bone augmentation 6 months prior to implant placement * Adequate oral hygiene i.e. Full mouth bleeding score (FMBS) \<20% and Full mouth plaque score (FMPS) \< 20%)
Exclusion criteria
* Smokers more than 10 cigarettes/day * Pregnant/lactating women * Alcoholics/drug addicts * Uncontrolled diabetics, immunocompromised, blood hemostasis problems * Patients taking IV bisphosphonates or drugs affecting bone metabolism or mucosal healing * Patients not willing to sign the consent form * History of radiotherapy in the head and neck region in the last 5 years * Active periodontitis on the remaining teeth
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline of alveolar ridge thickness at 4 months | During procedure and at 4 months | Peroperative surgical measurements of the alveolar ridge width at implant sites |
| Change from baseline of radiographic bone level on CBCT at 1 year post-op | During procedure and at 1 year | CBCT for buccal bone thickness measurements of the bone crest width at the implant site. |
| Change from baseline of radiographic bone level assessment at 1 year post-op, on periapical x-ray | During procedure, at 4 months, at 6 months and 1 year | 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 |
| Change from baseline of bone plate thickness at 4 months | During procedure and at 4 months | Peroperative buccal and lingual residual bone thickness following implant insertion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Histological analysis | During procedure | Bone core taken with a 2mm trephine bur at the site of implant placement for non-demineralized histological assessment of regenerated bone quality |
| Insertion torque | During procedure | Manual torque insertion are registered at implant placement. |
| Change of FMPS parameters from baseline to 1 year post-op | During procedure, at 6 months and at 1 year | Change in full mouth plaque score |
| Change of Clinical parameters from baseline to 1 year post-op | During procedure, at 6 months and at 1 year | FMBS, FMPS, |
| Change of FMBS parameters from baseline to 1 year post-op | During procedure, at 6 months and at 1 year | Change in full mouth bleeding score |
| Change of Keratinized tissue height from Baseline to 4 months | During procedure and at 4 months | Measured using a 1.0-mm marked periodontal probe |
Countries
Lebanon
Outcome results
None listed