Lycopene vs Minocycline Hydrochloride as Adjunctive to Periodontal Treatment

NCT03964935 | Unknown Phase 2

• 1 other identifier: 013618
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Periodontal Pocket

Outcome Measures

Primary Outcomes (3)

• 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

  14 days

• Measuring clinical attachment level

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

  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.

  14 day

Study Arms (3)

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.

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.

Drug: Minocycline HCl 1mg Oral Powder

Distilled water

PLACEBO COMPARATOR

Used to irrigate periodontal pockets after SRP

Other: Distilled water

Interventions

Lycopene DRUG

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.

Lycopene

Minocycline HCl 1mg Oral Powder DRUG

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

Minocycline HCL

Distilled water OTHER

Used to irrigate periodontal pockets after SRP

Distilled water

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Baghdad: lead

Study Sites (1)

College of Dentistry/ University of Baghdad

Baghdad, Iraq

Location

MeSH Terms

Conditions

Periodontal Pocket

Interventions

Lycopene; Minocycline; Powders

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Pigments, Biological; Biological Factors; Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Aya H Ali

  College of Dentistry/ University of Baghdad

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: May 20, 2019
• First Posted: May 28, 2019
• Study Start: December 1, 2018
• Primary Completion: August 30, 2019
• Study Completion: August 30, 2019
• Last Updated: May 28, 2019

Record last verified: 2019-05

Locations

IR (1)