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Effect of Locally Delivered Antioxidants as An Adjunct to Non-surgical Periodontal Therapy on GCF Level of Oxidative Stress Marker; Protein Carbonyl
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I: Lycopene + SRP | Experimental | Lycopene, 0.1 ml injected once in the periodontal pocket after scaling and root planing |
|
| Group II: SRP only | Active Comparator | Scaling and root planing only without lycopene |
|
| Group III: healthy subjects | No Intervention | No intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lycopene + SRP | Drug |
| ||
| SRP only |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Plaque index | To assess changes in plaque index following local delivery of stained release form of lycopene. | 6 months |
| Modified gingival index | to assess changes in the gingival index following local delivery of sustained release form of lycopene. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ahmed Y Gamal, PhD | AinShams university | Study Director |
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| ID | Term |
|---|---|
| D055113 | Chronic Periodontitis |
| ID | Term |
|---|---|
| D010518 | Periodontitis |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D000077276 | Lycopene |
| ID | Term |
|---|---|
| D002338 | Carotenoids |
| D011090 | Polyenes |
| D000475 | Alkenes |
| D006839 | Hydrocarbons, Acyclic |
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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.
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No masking
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|
| 6 months |
| Probing depth | To assess probing depth following local delivery of stained release form of lycopene. | 6 months |
| Clinical attachment loss | To assess clinical attachment loss following local delivery of sustained release form of lycopene. | 6 minths |
| Radiographic changes | to assess radiographic changes in the infrabony defects following local delivery of sustained release form of lycopene. | 6 months |
| Drug release | to assess rate of lycopene release using high performance liquid chromatography technique (HPLC). | 1 month |
| D002908 |
| Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D053138 | Cyclohexenes |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D013729 | Terpenes |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |