Chronic Periodontitis
Conditions
Keywords
Lycopene, Chronic periodontitis, Protein carbonyl
Brief summary
Effect of Locally Delivered Antioxidants as An Adjunct to Non-surgical Periodontal Therapy on GCF Level of Oxidative Stress Marker; Protein Carbonyl
Detailed 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.
Interventions
DRUGLycopene + SRP
PROCEDURESRP only
Sponsors
Maie Sami tawfik
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
No masking
Intervention model description
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 (SRP) 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 (SRP) only. Group III: Included 8 patients with clinically healthy periodontium.
Eligibility
Sex/Gender
ALL
Age
35 Years to 52 Years
Healthy volunteers
Yes
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, β-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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| GCF level of protein carbonyl | 1 month | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical attachment loss | 6 minths | To assess clinical attachment loss following local delivery of sustained release form of lycopene. |
| Radiographic changes | 6 months | to assess radiographic changes in the infrabony defects following local delivery of sustained release form of lycopene. |
| Probing depth | 6 months | To assess probing depth following local delivery of stained release form of lycopene. |
| Plaque index | 6 months | To assess changes in plaque index following local delivery of stained release form of lycopene. |
| Modified gingival index | 6 months | to assess changes in the gingival index following local delivery of sustained release form of lycopene. |
| Drug release | 1 month | to assess rate of lycopene release using high performance liquid chromatography technique (HPLC). |
Outcome results
None listed