Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Tanta University | OTHER |
Not provided
Not provided
Not provided
The goal of this clinical trial is to compare the efficacy of Noisome as carrier of minocycline hydrochloride gel to minocycline hydrochloride in Stage II or Stage III Periodontitis . The main questions it aims to answer are:
This study is designed to be a Randomized, Controlled, blinded, clinical trial; the eligible participants will be randomly allocated for one of the two comparative parallel-Groups; test and control group . The interventions will be prepared by the pharmacist and coded and the whole-time frame for the study will be 18 weeks.
The intervention to all participants will be Non-surgical debridement the the test group will receive the Noisome minocycline hydrochloride & control group will receive minocycline hydrochloride.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Minocycline hydrochloride with noisome as carrier | Experimental | Group I ( Minocycline hydrochloride with noisome carrier) 15 patients will receive the drug ( Minocycline hydrochloride with noisome carrier gel) at intervals 1,3,7&14 days |
|
| Minocycline hydrochoride only | Active Comparator | Group II (Minocycline hydrochloride only) 15 patients will receive the drug (Minocycline hydrochloride only gel) at intervals 1,3,7&14 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Minocycline hydrochloride with noisome carrier | Drug | patient will receive Non-surgical debridement followed by injection of local delivery drug in the deepest pocket site, This will be done one day, three days, seven days and fourteen days |
| Measure | Description | Time Frame |
|---|---|---|
| To measure clinical assessment Plaque Index (PI) in both groups (mincycline hydrochloride with noisome as carrier & minocycline hydrochloride only) | To measure the clinical parameter Plaque Index (PI) on score from zero to three 0 = No plaque in gingival area.
| measured at the baseline, before the application of drug& after 18 weeks |
| To measure clinical assessment Gingival Index (GI) in both groups (mincycline hydrochloride with noisome as carrier & minocycline hydrochloride only) | To measure the clinical parameter gingival Index(GI) on score from zero to three Gingival index (GI) 0 = Normal gingiva.
| measured at the baseline, before the application of drug& after 18 weeks |
| To measure Clinical attachment level (CAL) in both groups (mincycline hydrochloride with noisome as carrier & minocycline hydrochloride only) | To measure Clinical attachment level (CAL) in millimeter (mm). | measured at the baseline, before the application of drug& after 18 weeks |
| To measure Periodontal Pocket Depth (PPD) in both groups (mincycline hydrochloride with noisome as carrier & minocycline hydrochloride only) | To measure Periodontal Pocket Depth (PPD) in millimeter (mm). | measured at the baseline, before the application of drug& after 18 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| - Evaluate the releasing profile of minocycline hydrochloride noisome gel and minocycline hydrochloride gel | change in number of releasing profile of each drug | first day then third day then seventh day lastly after fourteen days |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Israa Said, B.D.S | Contact | +201096872828 | israasaiid94@gmail.com | |
| Asmaa Zayan, MS | Contact | +201012003865 | asmaazaya810@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Yasmin Fouad, PHD | AinShams University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AinShams University | Cairo | Egypt |
|
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23055582 | Background | Jain R, Mohamed F, Hemalatha M. Minocycline containing local drug delivery system in the management of chronic periodontitis: A randomized controlled trial. J Indian Soc Periodontol. 2012 Apr;16(2):179-83. doi: 10.4103/0972-124X.99259. | |
| 20103469 | Background | Apatzidou DA, Kinane DF. Nonsurgical mechanical treatment strategies for periodontal disease. Dent Clin North Am. 2010 Jan;54(1):1-12. doi: 10.1016/j.cden.2009.08.006. |
Not provided
Not provided
sharing the inclusion& exclusion criteria , study design, intervention ,statistical data &references.
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010518 | Periodontitis |
| C562573 | cyclopia sequence |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D008911 | Minocycline |
| ID | Term |
|---|---|
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Minocycline Hydrochloride only | Drug | patient will receive Non-surgical debridement followed by injection of local delivery drug in the deepest pocket site, This will be done one day, three days, seven days and fourteen days |
|
| AinShams University | Cairo | Egypt |
|
| 16460239 | Background | Cortelli JR, Querido SM, Aquino DR, Ricardo LH, Pallos D. Longitudinal clinical evaluation of adjunct minocycline in the treatment of chronic periodontitis. J Periodontol. 2006 Feb;77(2):161-6. doi: 10.1902/jop.2006.040409. |
| 21519133 | Background | Nakao R, Takigawa S, Sugano N, Koshi R, Ito K, Watanabe H, Senpuku H. Impact of minocycline ointment for periodontal treatment of oral bacteria. Jpn J Infect Dis. 2011;64(2):156-60. |
| Background | Uchegbu IF, Vyas SP (2015). Non-Ionic surfactant based vesicles (noisome) in drug delivery. Int J Pharm. ;172:33-70. |
| 11759865 | Background | Williams RC, Paquette DW, Offenbacher S, Adams DF, Armitage GC, Bray K, Caton J, Cochran DL, Drisko CH, Fiorellini JP, Giannobile WV, Grossi S, Guerrero DM, Johnson GK, Lamster IB, Magnusson I, Oringer RJ, Persson GR, Van Dyke TE, Wolff LF, Santucci EA, Rodda BE, Lessem J. Treatment of periodontitis by local administration of minocycline microspheres: a controlled trial. J Periodontol. 2001 Nov;72(11):1535-44. doi: 10.1902/jop.2001.72.11.1535. |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |