Ridge Preservation TechniquePhase 2NCT02057926
The Effect of Tetracycline in Degradation and Permeability of Collagen Membrane
A Phase 2 study testing The effect of tetracycline in degradation and permeability of collagen membranes. in people with Ridge Preservation Technique, run by Universitat Internacional de Catalunya at 1 site in Spain.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Ridge Preservation Technique
- What is being tested?
- The effect of tetracycline in degradation and permeability of collagen membranes.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSpain
- Study dates
- Nov 2009to Nov 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Universitat Internacional de Catalunya
Sant Cugat Del Vallès, Barcelona
About this study
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.
- Conditions
- Ridge Preservation Technique
- Being tested
- The effect of tetracycline in degradation and permeability of collagen membranes.
- Keywords
- Membrane degradation, Collagen membrane bio-durability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The effect of tetracycline in degradation and permeability of collagen membranes.Drug
| Study group | Role | What they receive |
|---|---|---|
| Tetracycline, Without Tetracycline | Experimental | The study consist in two groups: test group (membrane treated with tetracycline) and control group (membrane no treated with tetracycline). Receives: Drug: The effect of tetracycline in degradation and permeability of collagen membranes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the histological impact of treatment with tetracycline solution of two layers collagen membranes bio-degradation, in ridge preservation technique.
Measured: 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).
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.
Measured: 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.
Secondary outcomes (2)
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.
Measured: 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.
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2014 (estimated)
- Study startNov 2009
- Primary completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ridge Preservation TechniqueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitat Internacional de Catalunya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariana Baglivo, Universitat Internacional de Catalunya
- Investigators
- Mariana Baglivo Duarte, Periodontist, Principal investigator, Universitat Internacional de CatalunyaAntonio Santos, Periodontist, Study director, Universitat Internacional de Catalunya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02057926
- Sponsor's protocol ID
- C-45-ASA-08
- Status last verified
- Feb 2014
- First submitted
- 22 Jan 2014
- Last updated
- 7 Feb 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Tetracycline in Degradation and Permeability of Collagen Membrane
- ClinicalTrials.gov ID
- NCT02057926
- Acronym / sponsor ID
- C-45-ASA-08
- Conditions
- Ridge Preservation Technique
- Keywords
- Membrane degradation, Collagen membrane bio-durability
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Universitat Internacional de CatalunyaUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Nov 2011 (actual)
- First posted
- 7 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tetracycline, Without Tetracycline | Experimental | Drug: The effect of tetracycline in degradation and permeability of collagen membranes.The study consist in two groups: test group (membrane treated with tetracycline) and control group (membrane no treated with tetracycline). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The effect of tetracycline in degradation and permeability of collagen membranes. | Drug | Tetracycline, Without Tetracycline |
Primary outcome
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.
2 secondary outcomes
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mariana Baglivo Duarte, Periodontist principal investigator
Universitat Internacional de Catalunya
Antonio Santos, Periodontist study director
Universitat Internacional de Catalunya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing The effect of tetracycline in degradation and permeability of collagen membranes. in people with Ridge Preservation Technique, run by Universitat Internacional de Catalunya at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2014.