Efficacy of Noisome as A Carrier of Locally Delivered Minocycline Hydrochloride Gel
NCT ID: NCT06255067
Last Updated: 2024-02-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2/PHASE3
30 participants
INTERVENTIONAL
2024-02-25
2024-06-30
Brief Summary
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* 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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Minocycline hydrochloride with noisome as carrier
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 hydrochloride with noisome carrier
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
Minocycline hydrochoride only
Group II (Minocycline hydrochloride only)
15 patients will receive the drug (Minocycline hydrochloride only gel) at intervals 1,3,7\&14 days
Minocycline Hydrochloride only
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
Interventions
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Minocycline hydrochloride with noisome carrier
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
Minocycline Hydrochloride only
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
Eligibility Criteria
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Inclusion Criteria
* Generalized Periodontitis (Stage II or stage III ) Patients; ( ≥ 3 mm CAL, PD 5-7 mm ) , premolar-molar area (test site) .
* Having more than 16 tooth excluding wisdom and test teeth that still had both mesial and distal neighboring teeth.
* Systemically free according to the modified Burkitt's health history questionnaire
Exclusion Criteria
* Pregnancy or contraceptives usage.
* Breastfeeding.
* Known allergy to the ingredients of the treatment.
* Smokers.
* vulnerable group; prisoners \& orphans .
20 Years
50 Years
ALL
No
Sponsors
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Tanta University
OTHER
Ain Shams University
OTHER
Responsible Party
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israa saiid
MSc student
Principal Investigators
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Yasmin Fouad, PHD
Role: STUDY_DIRECTOR
AinShams University
Locations
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AinShams University
Cairo, , Egypt
AinShams University
Cairo, , Egypt
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
Uchegbu IF, Vyas SP (2015). Non-Ionic surfactant based vesicles (noisome) in drug delivery. Int J Pharm. ;172:33-70.
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.
Other Identifiers
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FDASU-RecIM022002
Identifier Type: -
Identifier Source: org_study_id
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