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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03203746
Other study ID # Maie Sami
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received June 24, 2017
Last updated June 28, 2017
Start date September 28, 2015
Est. completion date December 14, 2016

Study information

Verified date June 2017
Source Ain Shams University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Effect of Locally Delivered Antioxidants as An Adjunct to Non-surgical Periodontal Therapy on GCF Level of Oxidative Stress Marker; Protein Carbonyl


Description:

The study was designed as a randomized controlled clinical trial. Total subjects selected were allocated into three study groups, Group I (Test group), Group II (Positive control group) and Group III (Negative control group). Group I: Included 8 patients with severe chronic periodontitis managed by Scaling and root planing and local delivery of lycopene loaded in solid lipid microparticles. Group II: Included 8 patients with severe chronic periodontitis managed by Scaling and root planing only. Group III: Included 8 patients with clinically healthy periodontium.

Protein carbonyl biomarker level and clinical parameters were assisted to evaluate the effect of lycopene as an adjunct to scaling and root planing.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date December 14, 2016
Est. primary completion date November 10, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 35 Years to 52 Years
Eligibility Inclusion Criteria:

- All subjects were free from any systemic diseases.

- Subjects for group I and II were suffering from severe chronic periodontitis (Armitage et al., 1999).

- Group III included subjects with clinically healthy periodontium.

- All subjects were between 35-60 years old.

- Both genders were included.

- Subjects were able to return for follow up visits.

- Subjects agreed to sign a written consent after the nature of the study was explained.

Exclusion Criteria:

- History of scaling and root planing or periodontal surgery < 6 months prior to initiation of the study.

- History of administration of antimicrobial drugs or over the counter antioxidants like Vit C, Vit B, ß-carotene < 6 months prior to the baseline examination.

- Subjects who reported any side effects or drug allergies from antioxidants.

- Subjects with mobile teeth, abscesses and defected restorations related to the affected sites.

- Subjects with para-functional habits.

- Pregnant and lactating females.

- Smokers, alcoholic and drug abusers.

- Prisoner.

- Mentally retarded patients.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Lycopene + SRP

Procedure:
SRP only


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Maie Sami tawfik

Outcome

Type Measure Description Time frame Safety issue
Primary GCF level of protein carbonyl to assess GCF level of protein carbonyl following local delivery of sustained release form of lycopene as an adjunct to scaling and root planning (SRP) in management of severe chronic periodontitis patients. 1 month
Secondary Plaque index To assess changes in plaque index following local delivery of stained release form of lycopene. 6 months
Secondary Modified gingival index to assess changes in the gingival index following local delivery of sustained release form of lycopene. 6 months
Secondary Probing depth To assess probing depth following local delivery of stained release form of lycopene. 6 months
Secondary Clinical attachment loss To assess clinical attachment loss following local delivery of sustained release form of lycopene. 6 minths
Secondary Radiographic changes to assess radiographic changes in the infrabony defects following local delivery of sustained release form of lycopene. 6 months
Secondary Drug release to assess rate of lycopene release using high performance liquid chromatography technique (HPLC). 1 month
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