Lycopene vs Minocycline Hydrochloride as Adjunctive to Periodontal Treatment

NCT03964935 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2019-05-28

No results posted yet for this study

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

Interventions

DRUG

Lycopene

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.

DRUG

Minocycline HCl 1mg Oral Powder

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

OTHER

Distilled water

Used to irrigate periodontal pockets after SRP

Sponsors & Collaborators

  • University of Baghdad

    lead OTHER

Principal Investigators

  • Aya H Ali · College of Dentistry/ University of Baghdad

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-12-01
Primary Completion
2019-08-30
Completion
2019-08-30

Countries

  • Iraq

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03964935 on ClinicalTrials.gov