Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Twelve participants with edentulous alveolar crests in the distal portion of the arches will be included in the study. At least two implant sites will be identified in each patient and will be sub-prepared with drills or sonic instruments. One site will be used as a test and one as a control where experimental mini-implants will be installed. Reconstructive surgical procedures will be applied at the biopsy sites.
Objective: - To evaluate histologically the influence of the functional load on implants, both immediate and delayed.
Material and methods: 12 participants with edentulous alveolar crests in the distal portion of the arches will be included in the study. At least two implant sites will be identified in each patient and will be sub-prepared with drills or sonic instruments to obtain a high degree of torque to ensure optimum primary stability. At least one site will be used as a test and one as a control where experimental mini-implants will be installed. Test sites will be loaded immediately. The control sites will remain unloaded. After 2 months, mini-implants will be recovered as planned for each group. Reconstructive surgical procedures will be applied at the biopsy sites, if necessary, using autologous bone or bone substitutes and membranes. Standard implants will be installed during the same surgical session and, after 2 months, the planned prosthesis will be performed. Patients will be followed for at least 2 years for evaluation and intervention, if necessary.
Biopsies will be included in resin to obtain wear cuts for histomorphometric analysis. The bone histomorphometry will be evaluated and statistical analysis will be carried out.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate implant Loading | Experimental | Immediate loading is defined as the placement of the implant and immediate prosthetic restoration |
|
| non implant loading | No Intervention | there is not immediate prosthetic restoration |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| immediate loading | Procedure | The participants will be assigned to immediate or delayed functional loading groups. In each participant, edentulous areas with adequate thickness of the alveolar bone crest will be identified and at least two sites will be identified for implant installation. All implant recipient sites will be sub-prepared to allow good stability of the implants. Experimental mini-implants (Sweden & Martina, Due Carrare, Padova, Italy), 3.5 mm in diameter and with an intraosseous portion of 4 mm in length will be installed. Immediate loading group - A prosthetic component will be applied over the trial implants. Impressions will be taken and a crown / bridge will be provided to patients in one day. |
| Measure | Description | Time Frame |
|---|---|---|
| bone to implant contact | The linear distances between IS and B (IS-B) and CM and X (CM-X) were measured parallel to the long axis of the implant at both sides of the implant at a magnification of x100. Moreover, the amount of new bone, old bone, total bone (new + old bone = BIC% | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Bone density | The total amount of mineralized bone in contact with the implant surface measured histomorphometrically | 2 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
patients with edentulous spaces
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Daniele Botticelli, PHd | ARDEC Academy | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Colombia | Cartagena | Cartagena | 5710 | Colombia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18031442 | Background | Bousdras VA, Walboomers F, Jansen JA, Cunningham JL, Blunn G, Petrie A, Jaecques S, Naert IE, Sindet-Pedersen S, Goodship AE. Immediate functional loading of single-tooth TiO2 grit-blasted implant restoration. A controlled prospective study in a porcine model. Part II: Histology and histomorphometry. Clin Implant Dent Relat Res. 2007 Dec;9(4):207-16. doi: 10.1111/j.1708-8208.2007.00039.x. | |
| 12691653 |
Not provided
Not provided
there is a plan to save all the data to do the follow up
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 10, 2017 | Oct 18, 2018 | Prot_000.pdf |
Not provided
| ID | Term |
|---|---|
| D057893 | Immediate Dental Implant Loading |
| D019736 | Prostheses and Implants |
| ID | Term |
|---|---|
| D003758 | Dental Implantation, Endosseous |
| D003757 | Dental Implantation |
| D013516 | Oral Surgical Procedures, Preprosthetic |
| D019647 | Oral Surgical Procedures |
Not provided
Not provided
Split mouth, At least one site will be used as a test and one as a control where experimental mini-implants will be installed.
Not provided
Not provided
One of the researchers , neither involved in the selection of the patients nor in the surgical and prosthetic treatment, will carry out electronically the randomization (randomization.com). Will be prepared sealed opaque envelopes and opened at the time of surgery.
|
|
| non implant loading | Procedure | Control implants will receive a healing screw and will remain unloaded |
|
|
| Background |
| Calandriello R, Tomatis M, Vallone R, Rangert B, Gottlow J. Immediate occlusal loading of single lower molars using Branemark System Wide-Platform TiUnite implants: an interim report of a prospective open-ended clinical multicenter study. Clin Implant Dent Relat Res. 2003;5 Suppl 1:74-80. doi: 10.1111/j.1708-8208.2003.tb00018.x. |
| 22092689 | Background | Cecchinato D, Bressan EA, Toia M, Araujo MG, Liljenberg B, Lindhe J. Osseointegration in periodontitis susceptible individuals. Clin Oral Implants Res. 2012 Jan;23(1):1-4. doi: 10.1111/j.1600-0501.2011.02293.x. Epub 2011 Nov 1. |
| 14620684 | Background | Degidi M, Petrone G, Lezzi G, Piattelli A. Histologic evaluation of 2 human immediately loaded and 1 titanium implants inserted in the posterior mandible and submerged retrieved after 6 months. J Oral Implantol. 2003;29(5):223-9. doi: 10.1563/1548-1336(2003)0292.3.CO;2. |
| 19865630 | Background | Degidi M, Piattelli A, Shibli JA, Perrotti V, Iezzi G. Bone formation around immediately loaded and submerged dental implants with a modified sandblasted and acid-etched surface after 4 and 8 weeks: a human histologic and histomorphometric analysis. Int J Oral Maxillofac Implants. 2009 Sep-Oct;24(5):896-901. |
| 14536043 | Background | Degidi M, Scarano A, Petrone G, Piattelli A. Histologic analysis of clinically retrieved immediately loaded titanium implants: a report of 11 cases. Clin Implant Dent Relat Res. 2003;5(2):89-93. doi: 10.1111/j.1708-8208.2003.tb00189.x. |
| 21561477 | Result | Bosshardt DD, Salvi GE, Huynh-Ba G, Ivanovski S, Donos N, Lang NP. The role of bone debris in early healing adjacent to hydrophilic and hydrophobic implant surfaces in man. Clin Oral Implants Res. 2011 Apr;22(4):357-64. doi: 10.1111/j.1600-0501.2010.02107.x. |
| D013514 | Surgical Procedures, Operative |
| D019919 | Prosthesis Implantation |
| D003813 | Dentistry |
| D011476 | Prosthodontics |
| D004864 | Equipment and Supplies |