Immediate Loading a Histological Study

Edentulous Alveolar Ridge Clinical Trial

Official title:

Immediate Loading-A Histological Study in Humans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03714139
• Other study ID #: dental implants
• Status: Completed
• Phase: N/A
• Start date: March 3, 2018
• Est. completion date: February 28, 2020

Study information

• Verified date: September 2020
• Source: ARDEC Academy
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: February 28, 2020
• Est. primary completion date: January 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Edentulous Alveolar Ridge
• Mouth, Edentulous

Intervention

Procedure:
• immediate loading
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.
• non implant loading
Control implants will receive a healing screw and will remain unloaded

Locations

Country	Name	City	State
Colombia	Colombia	Cartagena de Indias	Cartagena

Sponsors (1)

Lead Sponsor	Collaborator
ARDEC Academy

Country where clinical trial is conducted

Colombia, 

References & Publications (7)

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 — View Citation

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. — View Citation

Calandriello R, Tomatis M, Vallone R, Rangert B, Gottlow J. Immediate occlusal loading of single lower molars using Brånemark 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. — View Citation

Cecchinato D, Bressan EA, Toia M, Araújo 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Bone density	The total amount of mineralized bone in contact with the implant surface measured histomorphometrically	2 months