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Immediate Loading a Histological Study

Primary Purpose

Edentulous Alveolar Ridge

Status
Completed
Phase
Not Applicable
Locations
Colombia
Study Type
Interventional
Intervention
immediate loading
non implant loading
Sponsored by
ARDEC Academy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Edentulous Alveolar Ridge focused on measuring Dental Implants, bone healing, clinical trial, histology

Eligibility Criteria

25 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Colombia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Immediate implant Loading

non implant loading

Arm Description

Immediate loading is defined as the placement of the implant and immediate prosthetic restoration

there is not immediate prosthetic restoration

Outcomes

Primary Outcome Measures

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%

Secondary Outcome Measures

Bone density
The total amount of mineralized bone in contact with the implant surface measured histomorphometrically

Full Information

First Posted
October 17, 2018
Last Updated
September 30, 2020
Sponsor
ARDEC Academy
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1. Study Identification

Unique Protocol Identification Number
NCT03714139
Brief Title
Immediate Loading a Histological Study
Official Title
Immediate Loading-A Histological Study in Humans
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
March 3, 2018 (Actual)
Primary Completion Date
January 30, 2019 (Actual)
Study Completion Date
February 28, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ARDEC Academy

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Edentulous Alveolar Ridge
Keywords
Dental Implants, bone healing, clinical trial, histology

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Split mouth, At least one site will be used as a test and one as a control where experimental mini-implants will be installed.
Masking
InvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Immediate implant Loading
Arm Type
Experimental
Arm Description
Immediate loading is defined as the placement of the implant and immediate prosthetic restoration
Arm Title
non implant loading
Arm Type
No Intervention
Arm Description
there is not immediate prosthetic restoration
Intervention Type
Procedure
Intervention Name(s)
immediate loading
Other Intervention Name(s)
implant surgery, prosthesis
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
non implant loading
Other Intervention Name(s)
control site
Intervention Description
Control implants will receive a healing screw and will remain unloaded
Primary Outcome Measure Information:
Title
bone to implant contact
Description
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%
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Bone density
Description
The total amount of mineralized bone in contact with the implant surface measured histomorphometrically
Time Frame
2 months

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
patients with edentulous spaces
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniele Botticelli, PHd
Organizational Affiliation
ARDEC Academy
Official's Role
Study Director
Facility Information:
Facility Name
Colombia
City
Cartagena de Indias
State/Province
Cartagena
ZIP/Postal Code
5710
Country
Colombia

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
there is a plan to save all the data to do the follow up
Citations:
PubMed Identifier
18031442
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. doi: 10.1111/j.1708-8208.2007.00039.x.
Results Reference
background
PubMed Identifier
12691653
Citation
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.
Results Reference
background
PubMed Identifier
22092689
Citation
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.
Results Reference
background
PubMed Identifier
14620684
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. doi: 10.1563/1548-1336(2003)0292.3.CO;2.
Results Reference
background
PubMed Identifier
19865630
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.
Results Reference
background
PubMed Identifier
14536043
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. doi: 10.1111/j.1708-8208.2003.tb00189.x.
Results Reference
background
PubMed Identifier
21561477
Citation
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.
Results Reference
result

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Immediate Loading a Histological Study

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