PeriodontitisPhase 2/3NCT06255067
Efficacy of Noisome as A Carrier of Locally Delivered Minocycline Hydrochloride Gel
A Phase 2/3 study testing Minocycline hydrochloride with noisome carrier and Minocycline Hydrochloride only in people with Periodontitis, run by Ain Shams University at 2 sites in Egypt.
Trial 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 . Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Periodontitis
- What is being tested?
- Minocycline hydrochloride with noisome carrier and Minocycline Hydrochloride only
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesEgypt
- Study dates
- 25 Feb 2024to 30 Jun 2024
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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 .
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
AinShams University
Cairo
Israa Said, B.D.S, +201096872828, israasaiid94@gmail.com
Asmaa Zayan, MS, +201012003865, asmaazaya810@gmail.com
AinShams University
Cairo
Israa Said, B.D.S, +201096872828, israasaiid94@gmail.com
Asmaa Zayan, MS, +201096872828, asmaazaya810@gmail.com
About this study
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"
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.
Read the 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.
- Conditions
- Periodontitis
- Being tested
- Minocycline hydrochloride with noisome carrier, Minocycline Hydrochloride only
- Keywords
- Minocycline hydrochloride
- Medical subject headings
- Periodontitis, cyclopia sequence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minocycline hydrochloride with noisome carrierDrug
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 onlyDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Minocycline Hydrochloride only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- = 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.
- = 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.
- = Abundance of soft matter within the gingival pocket and/or on the gingival margin and adjacent tooth surface.
Measured: 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.
- = Mild inflammation, slight change in color, slight edema; no bleeding on probing.
- = Moderate inflammation, redness, edema, and glazing; bleeding on probing.
- = Sever inflammation, marked redness and edema, ulceration; tendency to spontaneous bleeding.
Measured: 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: 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: 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
change in number of releasing profile of each drug
Measured: first day then third day then seventh day lastly after fourteen days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2024
- Study start25 Feb 2024 (estimated)
- Primary completion25 May 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Collaborators
- Tanta University
- Responsible party
- Principal investigator, israa saiid, Ain Shams University
- Investigators
- Yasmin Fouad, PHD, Study director, AinShams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06255067
- Sponsor's protocol ID
- FDASU-RecIM022002
- Status last verified
- Feb 2024
- First submitted
- 26 Dec 2023
- Last updated
- 12 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: sharing the inclusion\& exclusion criteria , study design, intervention ,statistical data \&references.
Publications
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.
PubMed 23055582Apatzidou 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.
PubMed 20103469Cortelli 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.
PubMed 16460239Nakao 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.
PubMed 21519133Uchegbu 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.
PubMed 11759865
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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"
- ClinicalTrials.gov ID
- NCT06255067
- Acronym / sponsor ID
- FDASU-RecIM022002
- Conditions
- Periodontitis
- Keywords
- Minocycline hydrochloride
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Collaborators
- Tanta University
- Study start
- 25 Feb 2024 (estimated)
- Primary completion
- 25 May 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 12 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Minocycline hydrochloride with noisome as carrier | Experimental | Drug: Minocycline hydrochloride with noisome carrierGroup 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 | Drug: Minocycline Hydrochloride onlyGroup II (Minocycline hydrochloride only) 15 patients will receive the drug (Minocycline hydrochloride only gel) at intervals 1,3,7\&14 days |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Minocycline hydrochloride with noisome carrierpatient 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 | Drug | Minocycline hydrochloride with noisome as carrier |
| Minocycline Hydrochloride onlypatient 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 | Drug | Minocycline hydrochoride only |
Primary outcome
To measure clinical assessment Plaque Index (PI) in both groups (mincycline hydrochloride with noisome as carrier & minocycline hydrochloride only)
Time frame: measured at the baseline, before the application of drug& after 18 weeks
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.
To measure clinical assessment Gingival Index (GI) in both groups (mincycline hydrochloride with noisome as carrier & minocycline hydrochloride only)
Time frame: measured at the baseline, before the application of drug& after 18 weeks
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.
To measure Clinical attachment level (CAL) in both groups (mincycline hydrochloride with noisome as carrier & minocycline hydrochloride only)
Time frame: measured at the baseline, before the application of drug& after 18 weeks
To measure Clinical attachment level (CAL) in millimeter (mm).
To measure Periodontal Pocket Depth (PPD) in both groups (mincycline hydrochloride with noisome as carrier & minocycline hydrochloride only)
Time frame: measured at the baseline, before the application of drug& after 18 weeks
To measure Periodontal Pocket Depth (PPD) in millimeter (mm).
1 secondary outcome
- Evaluate the releasing profile of minocycline hydrochloride noisome gel and minocycline hydrochloride gel
Time frame: first day then third day then seventh day lastly after fourteen days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2024.
- Background: PubMed 23055582Jain 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.
- Background: PubMed 20103469Apatzidou 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.
- Background: PubMed 16460239Cortelli 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.
- Background: PubMed 21519133Nakao 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.
- BackgroundUchegbu IF, Vyas SP (2015). Non-Ionic surfactant based vesicles (noisome) in drug delivery. Int J Pharm. ;172:33-70.
- Background: PubMed 11759865Williams 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.
- Individual participant dataSharing planned: Yes. sharing the inclusion\& exclusion criteria , study design, intervention ,statistical data \&references.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yasmin Fouad, PHD study director
AinShams University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Minocycline hydrochloride with noisome carrier and Minocycline Hydrochloride only in people with Periodontitis, run by Ain Shams University at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Israa Said, B.D.S (+201096872828, israasaiid94@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To measure clinical assessment Plaque Index (PI) in both groups (mincycline hydrochloride with noisome as carrier & minocycline hydrochloride only) (time frame: measured at the baseline, before the application of drug& after 18 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06255067, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2024.