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Using local delivery drugs as adjunctive to scaling and root planing and evaluating gingival crevicular fluid (GCF) biological molecular markers (MMP-8).
Study sample and setting A sample size of twenty patients per group (number of groups = 2) (total sample size = 40 patients) is the sufficient required sample as statistically significant with 80% power. The sample size was calculated using g power version 3.1.9.2. patients will be recruited from the outpatient clinic of the Department of Oral Medicine, Periodontology, Diagnosis and Oral Radiology. Faculty of Dentistry, Alexandria University.
Treatment will be in accordance with the principles of the modified Helsinki code for human clinical studies (2013).
The clinical study will be conducted following the ethical guidelines for conduct of research on human subjects, by the Faculty of Dentistry, Alexandria University (IRB NO:00010556 - IORG 0008839).
Data management and statistical analysis The data will be processed and analysed using statistical package for social sciences program SPSS (20.0) software*. The study will include descriptive and analytical data. A P-value of less than 0.05 will be considered statistically significant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I (study group) | Experimental | Scaling and root planing + intra-pocket application of 2% Cymbopogon citratus (lemon-grass) gel |
|
| Group II (control group) | Placebo Comparator | Scaling and root planing +intra-pocket application of placebo gel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lemongrass essential oil gel | Drug | The lemongrass oil gel will be administered by means of a syringe with a bent, blunt-end needle. The needle will be carefully inserted into the periodontal pocket and the gel will be applied in the test sites in a gentle probing manner, attempting to fill the full extent of the pocket. The gel will be applied up to the gingival margin and the excess gel will be removed with sterile gauze. Periodontal dressing will be applied after the delivery of the drug, and they will be also asked not to eat for thirty minutes. After placement of the gel in situ, patients will be instructed to follow strict oral hygiene protocol and not chew hard or sticky foods at the gel placement sites for rest of the week. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of clinical attachment and periodontal probing pocket | Millimeters (mm) | at baseline and twelve weeks from intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| GCF concentration of MMP-8 | pg/ml | at baseline, one week, and twelve weeks from intervention. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nadein E Sharif | Alexandria University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alexandria University | Alexandria | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19680192 | Background | Bascones-Martinez A, Munoz-Corcuera M, Noronha S, Mota P, Bascones-Ilundain C, Campo-Trapero J. Host defence mechanisms against bacterial aggression in periodontal disease: Basic mechanisms. Med Oral Patol Oral Cir Bucal. 2009 Dec 1;14(12):e680-5. doi: 10.4317/medoral.14.e680. | |
| Background | Preshaw M. Periodontal disease pathogenesis. 13th ed. Newman M, Takei H, Klokkevold P, Carranza F, editors. Philadelphia: Elsevier - Health Sciences Division; 2018. | ||
| 29926489 |
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all collected IPD
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_ICF | Yes | No | Yes | Study Protocol and Informed Consent Form | Oct 17, 2019 | Oct 21, 2020 | Prot_ICF_000.pdf |
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| ID | Term |
|---|---|
| D010518 | Periodontitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D014080 | Tooth Exfoliation |
| D016745 | Root Planing |
| ID | Term |
|---|---|
| D009063 | Dental Physiological Phenomena |
| D055688 | Digestive System and Oral Physiological Phenomena |
| D012534 | Dental Scaling |
| D003777 | Dental Prophylaxis |
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-Cymbopogon citratus oil gel /-Placebo gel. will be intrapocket application as an adjunctive treatment to conventional therapy
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|
|
| Placebo | Drug | The placebo will be administered by means of a syringe with a bent, blunt-end needle. The needle will be carefully inserted into the periodontal pocket and the gel will be applied in the test sites in a gentle probing manner, attempting to fill the full extent of the pocket. The gel will be applied up to the gingival margin and the excess gel will be removed with sterile gauze. Periodontal dressing will be applied after the delivery of the drug, and they will be also asked not to eat for thirty minutes. After placement of the gel in situ, patients will be instructed to follow strict oral hygiene protocol and not chew hard or sticky foods at the gel placement sites for rest of the week. |
|
|
| Scaling and root planing | Procedure | Conventional mechanical treatment by ultra-sonic scalers |
|
| Background |
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| D010517 | Periodontics |
| D003813 | Dentistry |
| D013357 | Subgingival Curettage |
| D011313 | Preventive Dentistry |