The Effect of Tetracycline in Degradation and Permeability of Collagen Membrane
Information source: Universitat Internacional de Catalunya
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Ridge Preservation Technique
Intervention: The effect of tetracycline in degradation and permeability of collagen membranes. (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Universitat Internacional de Catalunya Official(s) and/or principal investigator(s): Mariana Baglivo Duarte, Periodontist, Principal Investigator, Affiliation: Universitat Internacional de Catalunya Antonio Santos, Periodontist, Study Director, Affiliation: Universitat Internacional de Catalunya
Summary
The main objective of this study was to evaluate the histological impact of treatment with
tetracycline (TTC) solution of two layers collagen membranes (CMs) bio-degradation, in ridge
preservation technique (RPT). Additionally, secondary objectives were to evaluate the effect
of TTC on bacterial colonization and inflammatory response. This is a randomized
simple-blind clinical trial. Consecutive patients referred to the Department of
Periodontology at Universitat Internacional de Catalunya (Barcelona, Spain), between
November 2009 and April 2011, were included in the study. This study was based on data
collected from 20 surgical sites in 10 systemically healthy patients requiring 2 extractions
with SPT. Before starting the surgery, the two teeth of each selected patient were
randomized in two groups. The test group underwent RPT with CMs embedded with TTC solution
(CMs TTC), and the control group was performed without TTC solution (CMs NO TTC).
Randomization was performed using SPSS software (version 18, SPSS Inc., Chicago, IL, USA).
In the test group, both membranes were first dipped for 5 minutes in TTC solution (50
mg/ml). This involved the use of 250 mg tablets of TTC and 5 ml of saline that were mixed in
a sterile trough. A sample of the membrane used in each SPT was retained as a negative
control sample. The membrane sample was retrieved 7 days after initial surgery. At 14 days
the suture was removed and a new control was performed within 1 month. A sample from the
negative control, test and control group was analyzed from each patient. The specimens were
fixed in a 10% formalin solution, dehydrated in a series of alcohols, embedded in paraffin,
and sectioned in 4-5μ. The sections were stained with hematoxylin and eosin and examined
with an Olympus BH-2 optical microscope. The stained sections were photographed with a
digital camera mounted on an optical microscope at magnification (x100, x200 and x400).
According to the findings of the present study, we can conclude that CMs exhibit rapid
degradation when exposed to the oral environment. Histological interpretation suggests that
CMs immersed in 50mg/ml TTC solution delay the CM degradation when exposed to the oral
environment. Statistical evaluation did not show any difference in bacterial colonization
and inflammatory response, but the findings may also be affected by the limited sample size.
The limits of the present study are the absence of histomorphometric analysis, the sample
size, and the lack of a long-term evaluation with clinical evidence of the advantages of
this technique. More clinical studies in humans are require to confirm the effect of TTC in
CMs degradation before we can make recommendations.
Clinical Details
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Evaluate the histological impact of treatment with tetracycline solution of two layers collagen membranes bio-degradation, in ridge preservation technique.The main objective of this study was to evaluate the histological impact of treatment with tetracycline (TTC) solution of two layers collagen membranes (CMs) bio-degradation, in ridge preservation technique (RPT).
Secondary outcome: Secondary objectives were to evaluate the effect of tetracycline on bacterial colonization.Secondary objectives were to evaluate the effect of TTC on inflammatory response.
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria: healthy patients with 2 teeth with hopless prognosis.
Exclusion Criteria: patients who had taken antibiotics 3 months prior to the study,
patients with serious systemic disease, such as uncontrolled diabetes, cardiovascular
disease and infectious diseases, patients that required antibiotic prophylaxis, patients
who had received radiotherapy to the head and neck or chemotherapy in the past 12 months
before treatment was proposed, untreated or uncontrolled periodontal disease,
noncompliance with oral hygiene instructions, smokers of more than 10 cigarettes per day,
pregnant women, patients allergic to tetracycline.
Locations and Contacts
Universitat Internacional de Catalunya, Sant Cugat del Vallès, Barcelona, Spain
Additional Information
Starting date: November 2009
Last updated: February 5, 2014
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