Immediate Loading a Histological Study
Immediate Loading-A Histological Study in Humans
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
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Cartagena
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Cartagena de Indias, Cartagena, Colombia, 5710
- Colombia
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Adult participants (≥25 years of age) with the need of at least two implants to replace teeth of the jaw will be included.
- Natural antagonist teeth have to be present both at test and control sites to guarantee occlusal contacts
Exclusion Criteria:
- untreated rampant caries or uncontrolled periodontal disease of the remaining teeth
- diabetes not controlled diabetes or any other systemic or local disease that could compromise postoperative healing and / or osseointegration
- need for systemic corticosteroids or any other medication that could compromise postoperative healing and / or osseointegration
- inability or unwillingness to return to follow-up not likely to be able to comply with the study procedures according to the judgment of the investigators
- pregnancy
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: Immediate implant Loading
Immediate loading is defined as the placement of the implant and immediate prosthetic restoration
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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.
Andra namn:
Control implants will receive a healing screw and will remain unloaded
Andra namn:
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Inget ingripande: non implant loading
there is not immediate prosthetic restoration
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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bone to implant contact
Tidsram: 2 months
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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
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Bone density
Tidsram: 2 months
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The total amount of mineralized bone in contact with the implant surface measured histomorphometrically
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2 months
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Samarbetspartners och utredare
Sponsor
Utredare
- Studierektor: Daniele Botticelli, PHd, ARDEC Academy
Publikationer och användbara länkar
Allmänna publikationer
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- Dental implants
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