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: * Is the Noisome carrier of minocycline hydrochloride has an effect in comparing to minocycline hydrochloride in Stage II or Stage III Periodontitis? * what is the release profile of of minocycline hydrochloride noisome gel and minocycline hydrochloride gel? Participants will be asked to maintain oral hygiene after application of treatment Researchers will compare the effect of noisome as a carrier of locally delivered minocycline hydrochloride gel to minocycline hydrochloride gel in stage II or stage III periodontitis patients as an adjunct to non-surgical periodontal treatment\] to see if Plaque Index (PI) , Gingival index,Clinical attachment level (CAL) \&Periodontal Pocket Depth decreased or not.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
30
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
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
AinShams University
Cairo, Egypt
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. 1. = A film of plaque adhering to the free gingival margin and adjacent area of tooth. The plaque may be recognized only by running a probe across the tooth surface. 2. = Moderate accumulation of soft deposit within the gingival pocket and on the gingival pocket and on the gingival margin and/or adjacent tooth surface that can be seen by naked eye. 3. = Abundance of soft matter within the gingival pocket and/or on the gingival margin and adjacent tooth surface.
Time frame: 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. 1. = Mild inflammation, slight change in color, slight edema; no bleeding on probing. 2. = Moderate inflammation, redness, edema, and glazing; bleeding on probing. 3. = Sever inflammation, marked redness and edema, ulceration; tendency to spontaneous bleeding.
Time frame: 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).
Time frame: 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).
Time frame: measured at the baseline, before the application of drug& after 18 weeks
- Evaluate the releasing profile of minocycline hydrochloride noisome gel and minocycline hydrochloride gel
change in number of releasing profile of each drug
Time frame: first day then third day then seventh day lastly after fourteen days
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