Chronic Periodontitis Clinical Trial
Official title:
Gingival Crevicular Fluid Levels of Protein Carbonyl Oxidative Stress Biomarker Following the Use of Locally Delivered Lycopene Antioxidants in Patients With Chronic Periodontitis - Randomized Clinical Trial
Verified date | June 2017 |
Source | Ain Shams University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Effect of Locally Delivered Antioxidants as An Adjunct to Non-surgical Periodontal Therapy on GCF Level of Oxidative Stress Marker; Protein Carbonyl
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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Maie Sami tawfik |
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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