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Lycopene vs Minocycline Hydrochloride as Adjunctive to Periodontal Treatment

Primary Purpose

Periodontal Pocket

Status
Unknown status
Phase
Phase 2
Locations
Iraq
Study Type
Interventional
Intervention
Lycopene
Minocycline HCl 1mg Oral Powder
Distilled water
Sponsored by
University of Baghdad
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontal Pocket

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • College of Dentistry/ University of Baghdad

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Lycopene

Minocycline HCL

Distilled water

Arm Description

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.

Minocycline HCL Microspheres, 1mg minocycline powder per cartridge. A locally applied antibiotic that is placed directly into the infected periodontal pocket following SCR.

Used to irrigate periodontal pockets after SRP

Outcomes

Primary Outcome Measures

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
Measuring clinical attachment level
Clinical attachment level (CAL) is measured at baseline and after using different interventions
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.

Secondary Outcome Measures

Full Information

First Posted
May 20, 2019
Last Updated
May 23, 2019
Sponsor
University of Baghdad
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1. Study Identification

Unique Protocol Identification Number
NCT03964935
Brief Title
Lycopene vs Minocycline Hydrochloride as Adjunctive to Periodontal Treatment
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
August 30, 2019 (Anticipated)
Study Completion Date
August 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Baghdad

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Pocket

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lycopene
Arm Type
Experimental
Arm Description
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.
Arm Title
Minocycline HCL
Arm Type
Active Comparator
Arm Description
Minocycline HCL Microspheres, 1mg minocycline powder per cartridge. A locally applied antibiotic that is placed directly into the infected periodontal pocket following SCR.
Arm Title
Distilled water
Arm Type
Placebo Comparator
Arm Description
Used to irrigate periodontal pockets after SRP
Intervention Type
Drug
Intervention Name(s)
Lycopene
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Minocycline HCl 1mg Oral Powder
Intervention Description
Minocycline HCl Microspheres, 1mg minocycline powder per cartridge. A locally applied antibiotic that is placed directly into the infected periodontal pocket following SCR.
Intervention Type
Other
Intervention Name(s)
Distilled water
Intervention Description
Used to irrigate periodontal pockets after SRP
Primary Outcome Measure Information:
Title
Measuring level of inflammatory markers MMP-9, TGF-Beta 1, IL-8, TIMP-1 in the gingival crevicular fluid
Description
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
Time Frame
14 days
Title
Measuring clinical attachment level
Description
Clinical attachment level (CAL) is measured at baseline and after using different interventions
Time Frame
14 days
Title
Measuring bleeding on probing
Description
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.
Time Frame
14 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aya H Ali
Organizational Affiliation
College of Dentistry/ University of Baghdad
Official's Role
Principal Investigator
Facility Information:
Facility Name
College of Dentistry/ University of Baghdad
City
Baghdad
Country
Iraq

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Lycopene vs Minocycline Hydrochloride as Adjunctive to Periodontal Treatment

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