Ridge Preservation Technique Clinical Trial
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.
| Status | Completed |
| Enrollment | 10 |
| Est. completion date | |
| Est. primary completion date | November 2011 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years to 80 Years |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Spain | Universitat Internacional de Catalunya | Sant Cugat del Vallès, Barcelona |
| Lead Sponsor | Collaborator |
|---|---|
| Universitat Internacional de Catalunya |
Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Evaluate the histological impact of treatment with tetracycline solution of two layers collagen membranes bio-degradation, in ridge preservation technique. | 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. | Yes | |
| Primary | 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). | 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. | 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. | Yes |
| Secondary | Secondary objectives were to evaluate the effect of tetracycline on bacterial colonization. | 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. | 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. | Yes |
| Secondary | Secondary objectives were to evaluate the effect of TTC on inflammatory response. | 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. | 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. | Yes |