Efficacy of Noisome as A Carrier of Locally Delivered Minocycline Hydrochloride Gel

NCT06255067 | Not Yet Recruiting Phase 2

• 1 other identifier: FDASU-RecIM022002
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Periodontitis

Keywords

Minocycline hydrochloride

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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

Secondary Outcomes (1)

• - Evaluate the releasing profile of minocycline hydrochloride noisome gel and minocycline hydrochloride gel

  first day then third day then seventh day lastly after fourteen days

Study Arms (2)

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

Drug: Minocycline hydrochloride with noisome carrier

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

Drug: Minocycline Hydrochloride only

Interventions

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

Minocycline hydrochloride with noisome as carrier

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

Minocycline hydrochoride only

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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 .

Sponsors & Collaborators

• Ain Shams University: lead
• Tanta University: collaborator

Study Sites (2)

AinShams University

Cairo, Egypt

Location

AinShams University

Cairo, Egypt

Location

Related Publications (6)

• 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.

  PMID: 23055582 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.

  PMID: 20103469 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.

  PMID: 16460239 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.

  PMID: 21519133 BACKGROUND

• Uchegbu IF, Vyas SP (2015). Non-Ionic surfactant based vesicles (noisome) in drug delivery. Int J Pharm. ;172:33-70.

  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.

  PMID: 11759865 BACKGROUND

MeSH Terms

Conditions

Periodontitis; cyclopia sequence

Interventions

Minocycline

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Yasmin Fouad, PHD

  AinShams University

  STUDY DIRECTOR

Central Study Contacts

Israa Said, B.D.S

CONTACT

+201096872828; israasaiid94@gmail.com

Asmaa Zayan, MS

CONTACT

+201012003865; asmaazaya810@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc student

Study Record Dates

• First Submitted: December 26, 2023
• First Posted: February 12, 2024
• Study Start: February 25, 2024
• Primary Completion: May 25, 2024
• Study Completion: June 30, 2024
• Last Updated: February 12, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

EG (2)