Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 6 of 137 for:    tetracycline

The Effect of Tetracycline in Degradation and Permeability of Collagen Membrane

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02057926
Recruitment Status : Completed
First Posted : February 7, 2014
Last Update Posted : February 7, 2014
Sponsor:
Information provided by (Responsible Party):
Mariana Baglivo, Universitat Internacional de Catalunya

Tracking Information
First Submitted Date  ICMJE January 22, 2014
First Posted Date  ICMJE February 7, 2014
Last Update Posted Date February 7, 2014
Study Start Date  ICMJE November 2009
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 5, 2014)
  • Evaluate the histological impact of treatment with tetracycline solution of two layers collagen membranes bio-degradation, in ridge preservation technique. [ Time Frame: On week after surgery, a sample of the expose membrane was obtained. The sections were stained with hematoxylin and eosin and examined with an Olympus BH-2 optical microscope. ]
  • 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). [ Time Frame: One week after the surgery, a sample of the expose membrane was obtained. The sections were stained with hematoxylin and eosin and examined with an Olympus BH-2 optical microscope. ]
    After 1 week, a sample of expose membrane was obtained. The bio-degradation of membrane was evaluated with a qualitative scale: 1) intact membrane, 2) partial degradation, 3) complete degradation.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 5, 2014)
  • Secondary objectives were to evaluate the effect of tetracycline on bacterial colonization. [ Time Frame: On week after surgery, a sample of expose membrane was obtained.The sections were stained with hematoxylin and eosin and examined with an Olympus BH-2 optical microscope. ]
    After 1 week, a sample of expose membrane was obtained. The bio-degradation of membrane was evaluated with a qualitative scale: 1) mild bacterial colonization, 2) moderate, 3) extensive.
  • Secondary objectives were to evaluate the effect of TTC on inflammatory response. [ Time Frame: One week after surgery, a sample of exposure membrane was obtained. The sections were stained with hematoxylin and eosin and examined with an Olympus BH-2 optical microscope. ]
    After 1 week, a sample of expose membrane was obtained. The bio-degradation of membrane was evaluated with a qualitative scale: 1) absence of inflammatory response, 2) mild, 3) moderate, 4) marked.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Tetracycline in Degradation and Permeability of Collagen Membrane
Official Title  ICMJE Not Provided
Brief 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Ridge Preservation Technique
Intervention  ICMJE Drug: The effect of tetracycline in degradation and permeability of collagen membranes.
Study Arms  ICMJE Experimental: Tetracycline, Without Tetracycline
The study consist in two groups: test group (membrane treated with tetracycline) and control group (membrane no treated with tetracycline).
Intervention: Drug: The effect of tetracycline in degradation and permeability of collagen membranes.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 5, 2014)
10
Original Actual Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02057926
Other Study ID Numbers  ICMJE C-45-ASA-08
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mariana Baglivo, Universitat Internacional de Catalunya
Study Sponsor  ICMJE Universitat Internacional de Catalunya
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mariana Baglivo Duarte, Periodontist Universitat Internacional de Catalunya
Study Director: Antonio Santos, Periodontist Universitat Internacional de Catalunya
PRS Account Universitat Internacional de Catalunya
Verification Date February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP