Clinical trial NCT06255067: Efficacy of Noisome as A Carrier of Locally Delivered Minocycline Hydrochloride Gel
Official title: "Efficacy of Noisome as A Carrier of Locally Delivered Minocycline Hydrochloride Gel in Stage II or Stage III Periodontitis: A Randomized Controlled Clinical Trial With Biochemical Analysis"
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Periodontitis
Keywords: Minocycline hydrochloride
Lead sponsor: Ain Shams University
Sponsor class: OTHER
Collaborators: name: Tanta University
First posted: 2024-02-12
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Participants willing to commit for the entire period of the trial and agreed to sign the written consent after full explanation of the study.
* 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:

* Non-surgical periodontal therapy within the previous 12 months, systemic or local use of antibiotics with the previous 3 months, medication with possible influence on the periodontium.
* Pregnancy or contraceptives usage.
* Breastfeeding.
* Known allergy to the ingredients of the treatment.
* Smokers.
* vulnerable group; prisoners \& orphans .

Primary outcomes:
measure: To measure clinical assessment Plaque Index (PI) in both groups (mincycline hydrochloride with noisome as carrier & minocycline hydrochloride only)
timeFrame: measured at the baseline, before the application of drug& after 18 weeks
measure: To measure clinical assessment Gingival Index (GI) in both groups (mincycline hydrochloride with noisome as carrier & minocycline hydrochloride only)
timeFrame: measured at the baseline, before the application of drug& after 18 weeks
measure: To measure Clinical attachment level (CAL) in both groups (mincycline hydrochloride with noisome as carrier & minocycline hydrochloride only)
timeFrame: measured at the baseline, before the application of drug& after 18 weeks
measure: To measure Periodontal Pocket Depth (PPD) in both groups (mincycline hydrochloride with noisome as carrier & minocycline hydrochloride only)
timeFrame: measured at the baseline, before the application of drug& after 18 weeks
Secondary outcomes:
measure: - Evaluate the releasing profile of minocycline hydrochloride noisome gel and minocycline hydrochloride gel
timeFrame: first day then third day then seventh day lastly after fourteen days
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: AinShams University
city: Cairo
country: Egypt
facility: AinShams University
Study officials:
affiliation: AinShams University
name: Yasmin Fouad, PHD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Uchegbu IF, Vyas SP (2015). Non-Ionic surfactant based vesicles (noisome) in drug delivery. Int J Pharm. ;172:33-70.
citation: 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.