Periodontal PocketPhase 2NCT03964935
Lycopene vs Minocycline Hydrochloride as Adjunctive to Periodontal Treatment
A Phase 2 study testing Lycopene, Minocycline HCl 1mg Oral Powder and Distilled water in people with Periodontal Pocket, run by University of Baghdad at 1 site in Iraq.
Trial summary
Periodontal diseases are among the most common medical conditions that may influence humans; 50% of the adult population can be affected by this illness. The condition is usually initiated by lack or reduction in oral hygiene which is then aggravated by the presence of microorganisms within biofilm which will induce a… Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periodontal Pocket
- What is being tested?
- Lycopene, Minocycline HCl 1mg Oral Powder and Distilled water
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteIraq
- Study dates
- 1 Dec 2018to 30 Aug 2019
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with chronic periodontitis with CAL ≥ 5 mm.
- No history of any systemic condition.
- Patient able to follow the required instructions.
- Willing to sign an informed consent form.
- Didn't receive any antibiotic therapy and periodontal therapy in the last 2-3 months.
Who cannot join
- Patients with systemic diseases that influence the condition (ex, hypertension, diabetes, kidney diseases and transplants).
- Patients who refuse to write an informed consent form.
- Smokers.
- Taking certain medications including antibiotics, antihypertensive, anticonvulsants, immunosuppressants, or any other drug that may affect the periodontal health status.
- Pregnant and lactating women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Lycopene Antioxidant Gel Compared to Minocycline Hydrochloride Microspheres as Adjunctive to Non Surgical Periodontal Treatment by Measuring Matrix Metalloproteinase-9, Transforming Growth Factor-Beta 1, Interleukin-8, and Tissue Inhibitor of Metalloproteinases -1
Periodontal diseases are among the most common medical conditions that may influence humans; 50% of the adult population can be affected by this illness. The condition is usually initiated by lack or reduction in oral hygiene which is then aggravated by the presence of microorganisms within biofilm which will induce a sequel of events that will lead to periodontitis. Scaling, root planning, and polishing (SRP) are the golden standard procedures in the treatment. Systemic antibiotics as adjunctive therapy has been established to be an excellent modality in controlling the bacterial virulence, hence, supporting the conventional SRP therapy. in order to avoid and limit the harmful effect of systemic antibiotics different locally applied preparations have been introduced including antioxidants. The aim of this prospective clinical study is to compare between the effect of Minocycline hydrochloride (HCL) microsphere and Lycopene gel when they are applied intrapocket subgingival with conventional SRP therapy
Read the detailed description
Periodontal diseases are among the most common medical conditions that may influence humans; 50% of the adult population can be affected by this illness. The condition is usually initiated by lack or reduction in oral hygiene which is then aggravated by the presence of microorganisms within biofilm which will induce a sequel of events that will lead to periodontitis. The multifactorial nature of the disease necessitates a multifactorial approach to restore the balance within the oral echo system. Scaling, root planning, and polishing (SRP) are the golden standard procedures in the treatment; the therapeutic nature of these clinical intervention is based on disrupting the biofilm and stimulate the host defense mechanism to have the upper hand in targeting the microorganisms and their toxins. Systemic antibiotics as adjunctive therapy has been established to be an excellent modality in controlling the bacterial virulence, hence, supporting the conventional SRP therapy; in order to avoid and limit the harmful effect of systemic antibiotics different locally applied preparations have been introduced. Clinical parameters bleeding on probing (BOP), pocket depth (PD), and clinical attachment level (CAL) have been improved when Minocycline hydrochloride (HCL) microspheres was locally applied as an adjunctive drug to conventional SRP. Oxidative stress is another factor related to periodontitis. The free radicals are a by-product of the inflammatory reaction induced by the disease progression; free radicals eliminated by antioxidants which is naturally found in the diet especially fruits and vegetables; however, when the imbalance occur and the free radicals over weighed the antioxidants there will be further initiation of the destruction mechanism. The role of antioxidant as therapeutic agent in reducing the oxidative stress has been well studied and their supporting effect to the conventional SRP treatment is well documented. Lycopene extract can be applied as a gel intrapocket subgingival and it can have a promising result with the SRP.
The aim of this prospective clinical study is to compare between the effect of Minocycline HCL microsphere and Lycopene gel when they are applied intrapocket subgingival with conventional SRP therapy. The study will utilize split mouth technique; three sites within the oral cavity that have a pocket depth greater than 5 mm will be included. Each site will be designated to receive a specific treatment, Control group (site) will have SRP and water irrigation treatment, active group (site) will have local application of Minocycline HCL gel following SRP therapy, and the experimental site which will receive lycopene and SRP treatment. The influence of these therapeutic agents will be determined by the expression of selected inflammation-related markers in the gingival crevicular fluid collected from the experimental sites. The markers that will be examined are MMP-9, interleukin (IL)-8, TGF-Beta 1, and TIMP1. The change in the clinical parameters will be measured before the commencement of treatment and it will be examined later to observe the effect of each locally applied drug when compared to the control group (SRP plus water irrigation).
- Conditions
- Periodontal Pocket
- Being tested
- Lycopene, Minocycline HCl 1mg Oral Powder, Distilled water
- Medical subject headings
- Periodontal Pocket
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LycopeneDrug
Prepared by solving lycopene powder in a solvent (ethanol: propylene glycol: water in the ratio of 50:30:20). The solution was then gelled by adding 8% hydroxypropyl cellulose (HPC). The concentration of the prepared gel equals to 2%.
After SRP, the gel delivered into periodontal pocket using insulin syringes, the therapeutic dose is about 2mg/0.1 ml.
Minocycline HCl 1mg Oral PowderDrug
Minocycline HCl Microspheres, 1mg minocycline powder per cartridge. A locally applied antibiotic that is placed directly into the infected periodontal pocket following SCR.
Distilled waterOther
Used to irrigate periodontal pockets after SRP
| Study group | Role | What they receive |
|---|---|---|
| Lycopene | Experimental | Prepared by solving lycopene powder in a solvent (ethanol: propylene glycol: water in the ratio of 50:30:20). The solution was then gelled by adding 8% hydroxypropyl cellulose (HPC). The concentration of the prepared gel equals to 2%.
After scaling, root planing, and polishing (SRP), the gel delivered into periodontal pocket using insulin syringes, the therapeutic dose is about 2mg/0.1 ml. Receives: Drug: Lycopene |
| Minocycline HCL | Active comparator | Minocycline HCL Microspheres, 1mg minocycline powder per cartridge. A locally applied antibiotic that is placed directly into the infected periodontal pocket following SCR. Receives: Drug: Minocycline HCl 1mg Oral Powder |
| Distilled water | Placebo comparator | Used to irrigate periodontal pockets after SRP Receives: Other: Distilled water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring level of inflammatory markers MMP-9, TGF-Beta 1, IL-8, TIMP-1 in the gingival crevicular fluid
Level of selected inflammatory markers (MMP-9, TGF-Beta 1, IL-8, TIMP-1) is measured in the gingival crevicular fluid before and after use of different interventions
Measured: 14 days
Measuring clinical attachment level
Clinical attachment level (CAL) is measured at baseline and after using different interventions
Measured: 14 days
Measuring bleeding on probing
Measuring bleeding on probing (BOP), indicated by score 0 (no bleeding) score 1 (bleeding), from periodontal pockets treated with different interventions at baseline and at the end of the trial period.
Measured: 14 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2019
- Study start1 Dec 2018
- Primary completion30 Aug 2019 (estimated)
- Study completion30 Aug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal PocketStudies of the same condition, open and under way.
- More trials run by University of BaghdadThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali A Abdulkareem, University of Baghdad
- Investigators
- Aya H Ali, Principal investigator, College of Dentistry/ University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03964935
- Sponsor's protocol ID
- 013618
- Status last verified
- May 2019
- First submitted
- 20 May 2019
- Last updated
- 28 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Lycopene Antioxidant Gel Compared to Minocycline Hydrochloride Microspheres as Adjunctive to Non Surgical Periodontal Treatment by Measuring Matrix Metalloproteinase-9, Transforming Growth Factor-Beta 1, Interleukin-8, and Tissue Inhibitor of Metalloproteinases -1
- ClinicalTrials.gov ID
- NCT03964935
- Acronym / sponsor ID
- 013618
- Conditions
- Periodontal Pocket
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 30 Aug 2019 (estimated)
- Study completion
- 30 Aug 2019 (estimated)
- First posted
- 28 May 2019 (actual)
- 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.
Periodontal diseases are among the most common medical conditions that may influence humans; 50% of the adult population can be affected by this illness. The condition is usually initiated by lack or reduction in oral hygiene which is then aggravated by the presence of microorganisms within biofilm which will induce a sequel of events that will lead to periodontitis. Scaling, root planning, and polishing (SRP) are the golden standard procedures in the treatment. Systemic antibiotics as adjunctive therapy has been established to be an excellent modality in controlling the bacterial virulence, hence, supporting the conventional SRP therapy. in order to avoid and limit the harmful effect of systemic antibiotics different locally applied preparations have been introduced including antioxidants. The aim of this prospective clinical study is to compare between the effect of Minocycline hydrochloride (HCL) microsphere and Lycopene gel when they are applied intrapocket subgingival with conventional SRP therapy
Detailed description
Periodontal diseases are among the most common medical conditions that may influence humans; 50% of the adult population can be affected by this illness. The condition is usually initiated by lack or reduction in oral hygiene which is then aggravated by the presence of microorganisms within biofilm which will induce a sequel of events that will lead to periodontitis. The multifactorial nature of the disease necessitates a multifactorial approach to restore the balance within the oral echo system. Scaling, root planning, and polishing (SRP) are the golden standard procedures in the treatment; the therapeutic nature of these clinical intervention is based on disrupting the biofilm and stimulate the host defense mechanism to have the upper hand in targeting the microorganisms and their toxins. Systemic antibiotics as adjunctive therapy has been established to be an excellent modality in controlling the bacterial virulence, hence, supporting the conventional SRP therapy; in order to avoid and limit the harmful effect of systemic antibiotics different locally applied preparations have been introduced. Clinical parameters bleeding on probing (BOP), pocket depth (PD), and clinical attachment level (CAL) have been improved when Minocycline hydrochloride (HCL) microspheres was locally applied as an adjunctive drug to conventional SRP. Oxidative stress is another factor related to periodontitis. The free radicals are a by-product of the inflammatory reaction induced by the disease progression; free radicals eliminated by antioxidants which is naturally found in the diet especially fruits and vegetables; however, when the imbalance occur and the free radicals over weighed the antioxidants there will be further initiation of the destruction mechanism. The role of antioxidant as therapeutic agent in reducing the oxidative stress has been well studied and their supporting effect to the conventional SRP treatment is well documented. Lycopene extract can be applied as a gel intrapocket subgingival and it can have a promising result with the SRP.
The aim of this prospective clinical study is to compare between the effect of Minocycline HCL microsphere and Lycopene gel when they are applied intrapocket subgingival with conventional SRP therapy. The study will utilize split mouth technique; three sites within the oral cavity that have a pocket depth greater than 5 mm will be included. Each site will be designated to receive a specific treatment, Control group (site) will have SRP and water irrigation treatment, active group (site) will have local application of Minocycline HCL gel following SRP therapy, and the experimental site which will receive lycopene and SRP treatment. The influence of these therapeutic agents will be determined by the expression of selected inflammation-related markers in the gingival crevicular fluid collected from the experimental sites. The markers that will be examined are MMP-9, interleukin (IL)-8, TGF-Beta 1, and TIMP1. The change in the clinical parameters will be measured before the commencement of treatment and it will be examined later to observe the effect of each locally applied drug when compared to the control group (SRP plus water irrigation).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lycopene | Experimental | Drug: LycopenePrepared by solving lycopene powder in a solvent (ethanol: propylene glycol: water in the ratio of 50:30:20). The solution was then gelled by adding 8% hydroxypropyl cellulose (HPC). The concentration of the prepared gel equals to 2%. After scaling, root planing, and polishing (SRP), the gel delivered into periodontal pocket using insulin syringes, the therapeutic dose is about 2mg/0.1 ml. |
| Minocycline HCL | Active comparator | Drug: Minocycline HCl 1mg Oral PowderMinocycline HCL Microspheres, 1mg minocycline powder per cartridge. A locally applied antibiotic that is placed directly into the infected periodontal pocket following SCR. |
| Distilled water | Placebo comparator | Other: Distilled waterUsed to irrigate periodontal pockets after SRP |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with chronic periodontitis with CAL ≥ 5 mm.
- No history of any systemic condition.
- Patient able to follow the required instructions.
- Willing to sign an informed consent form.
- Didn't receive any antibiotic therapy and periodontal therapy in the last 2-3 months.
Key exclusion criteria (5 listed)
- Patients with systemic diseases that influence the condition (ex, hypertension, diabetes, kidney diseases and transplants).
- Patients who refuse to write an informed consent form.
- Smokers.
- Taking certain medications including antibiotics, antihypertensive, anticonvulsants, immunosuppressants, or any other drug that may affect the periodontal health status.
- Pregnant and lactating women.
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 |
|---|---|---|
| LycopenePrepared by solving lycopene powder in a solvent (ethanol: propylene glycol: water in the ratio of 50:30:20). The solution was then gelled by adding 8% hydroxypropyl cellulose (HPC). The concentration of the prepared gel equals to 2%. After SRP, the gel delivered into periodontal pocket using insulin syringes, the therapeutic dose is about 2mg/0.1 ml. | Drug | Lycopene |
| Minocycline HCl 1mg Oral PowderMinocycline HCl Microspheres, 1mg minocycline powder per cartridge. A locally applied antibiotic that is placed directly into the infected periodontal pocket following SCR. | Drug | Minocycline HCL |
| Distilled waterUsed to irrigate periodontal pockets after SRP | Other | Distilled water |
Primary outcome
Measuring level of inflammatory markers MMP-9, TGF-Beta 1, IL-8, TIMP-1 in the gingival crevicular fluid
Time frame: 14 days
Level of selected inflammatory markers (MMP-9, TGF-Beta 1, IL-8, TIMP-1) is measured in the gingival crevicular fluid before and after use of different interventions
Measuring clinical attachment level
Time frame: 14 days
Clinical attachment level (CAL) is measured at baseline and after using different interventions
Measuring bleeding on probing
Time frame: 14 day
Measuring bleeding on probing (BOP), indicated by score 0 (no bleeding) score 1 (bleeding), from periodontal pockets treated with different interventions at baseline and at the end of the trial period.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2019.
- Individual participant dataSharing planned: Undecided
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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.
Aya H Ali principal investigator
College of Dentistry/ University of Baghdad
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 Lycopene, Minocycline HCl 1mg Oral Powder and Distilled water in people with Periodontal Pocket, run by University of Baghdad at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 28 May 2019. 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 Iraq. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
Measuring level of inflammatory markers MMP-9, TGF-Beta 1, IL-8, TIMP-1 in the gingival crevicular fluid (time frame: 14 days). The study lists 3 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 28 May 2019.