Chronic Generalized PeriodontitisPhase 4NCT02016157
Moxifloxacin in Situ Gel to Treat Periodontal Pocket.
A Phase 4 study testing Moxifloxacin in people with Chronic Generalized Periodontitis, run by Sri Hasanamba Dental College and Hospital at 1 site in India.
Trial summary
In this Randomized clinical trial locally delivered moxifloxacin in situ gel was evaluated as an adjunct to scaling and root planing for efficacy in the treatment of chronic periodontitis and for short-term effects on the periodontal microflora. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Chronic Generalized Periodontitis
- What is being tested?
- Moxifloxacin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteIndia
- Study dates
- Sep 2011to Nov 2012
- Phase
- Phase 4
- 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 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with good systemic health
- Patients with Chronic periodontitis with sites with probing pocket depth (PPD) of ≥ 5 mm
- a minimum of 12 natural teeth with radiographic evidence of bone loss
- willingness to comply with the study protocol.
Who cannot join
- Patients with a history of drug allergy to quinolones or those who were taking medication that might interact with moxifloxacin
- Patients with history of antibiotic coverage in the 6 months preceding the study
- Pregnant or lactating patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Moxifloxacin In Situ Gel as an Adjunct in the Treatment of Periodontal Pocket: A Randomized Clinical Trial.
In this Randomized clinical trial locally delivered moxifloxacin in situ gel was evaluated as an adjunct to scaling and root planing for efficacy in the treatment of chronic periodontitis and for short-term effects on the periodontal microflora.
Read the detailed description
Moxifloxacin exerts excellent antibacterial activity against a wide range of putative periodontal pathogens, including Porphyromonas gingivalis, Tannerella forsythia, Prevotella species, Fusobacterium nucleatum, Actinomyces species, Peptostreptococcus species, Campylobacter rectus, and Actinobacillus actinomycetemcomitans. Moxifloxacin penetrates well into soft tissues and is effective against intracellular periodontal pathogens when used in the treatment of periodontitis as an adjunct to scaling and root planning (SRP). Systemic administration of moxifloxacin has provided superior outcomes compared with SRP in conjunction with systemic administration of doxycycline, or SRP alone. We hypothesized similar benefits with local drug delivery of Moxifloxacin in the treatment of chronic periodontitis. To the best of our knowledge, there is no published literature on in situ gel using moxifloxacin employing gellan gum as the vehicle, for direct placement in the periodontal pocket for the treatment of chronic periodontitis.
Among various drug delivery systems for treating periodontitis, gel formulations have some advantages. Despite a relatively faster release of the drug, gels can be more easily prepared and administered. Moreover, they possess a higher bio compatibility and bio adhesivity, by allowing adhesion to the mucosa in the dental pocket and by decreasing the risk of dilution of the material by saliva.
Keeping the above facts in mind, the goals of this study were to (1) evaluate in situ gel as a vehicle in a local drug delivery system, (2) evaluate the efficacy of moxifloxacin for local drug delivery, (3) evaluate the efficacy of gellan gum for in situ gelation of moxifloxacin, and (4) evaluate and compare the clinical and microbiological parameters of moxifloxacin with those of the gold standard, chlorhexidine di gluconate.
- Conditions
- Chronic Generalized Periodontitis
- Being tested
- Moxifloxacin
- Keywords
- Moxifloxacin, Chlorhexidine, In situ gel, Chronic periodontitis
- Medical subject headings
- Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MoxifloxacinDrug
Also called Avelox
TO ASSESS THE EFFICACY OF MOXIFLOXACIN IN SITU GEL IN THE TREATMENT OF PERIODONTAL POCKET.
| Study group | Role | What they receive |
|---|---|---|
| Moxifloxacin, Chronic periodontitis | Experimental | 50 micrograms Moxifloxacin Receives: Drug: Moxifloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Clinical attachment level at 3 months in chronic periodontitis patients
The present randomized clinical trial assessed the effects of moxifloxacin, compared with chlorhexidine, locally administered via in situ gel formulation, on various clinical parameters describing periodontitis.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2013 (estimated)
- Study startSep 2011
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Generalized PeriodontitisStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sri Hasanamba Dental College and Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Shaurya Manjunath, Sri Hasanamba Dental College and Hospital
- Investigators
- Shaurya Manjunath, MDS, Principal investigator, Rajiv Gandhi University of Health Sceinces, Bangalore,Karnataka, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02016157
- Sponsor's protocol ID
- Shaurya Manjunath
- Status last verified
- Aug 2020
- First submitted
- 6 Nov 2013
- Last updated
- 13 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Guentsch A, Jentsch H, Pfister W, Hoffmann T, Eick S. Moxifloxacin as an adjunctive antibiotic in the treatment of severe chronic periodontitis. J Periodontol. 2008 Oct;79(10):1894-903. doi: 10.1902/jop.2008.070493.
PubMed 18834244
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Moxifloxacin In Situ Gel as an Adjunct in the Treatment of Periodontal Pocket: A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT02016157
- Acronym / sponsor ID
- Shaurya Manjunath
- Conditions
- Chronic Generalized Periodontitis
- Keywords
- Moxifloxacin, Chlorhexidine, In situ gel, Chronic periodontitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Sri Hasanamba Dental College and HospitalUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 19 Dec 2013 (estimated)
- 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.
In this Randomized clinical trial locally delivered moxifloxacin in situ gel was evaluated as an adjunct to scaling and root planing for efficacy in the treatment of chronic periodontitis and for short-term effects on the periodontal microflora.
Detailed description
Moxifloxacin exerts excellent antibacterial activity against a wide range of putative periodontal pathogens, including Porphyromonas gingivalis, Tannerella forsythia, Prevotella species, Fusobacterium nucleatum, Actinomyces species, Peptostreptococcus species, Campylobacter rectus, and Actinobacillus actinomycetemcomitans. Moxifloxacin penetrates well into soft tissues and is effective against intracellular periodontal pathogens when used in the treatment of periodontitis as an adjunct to scaling and root planning (SRP). Systemic administration of moxifloxacin has provided superior outcomes compared with SRP in conjunction with systemic administration of doxycycline, or SRP alone. We hypothesized similar benefits with local drug delivery of Moxifloxacin in the treatment of chronic periodontitis. To the best of our knowledge, there is no published literature on in situ gel using moxifloxacin employing gellan gum as the vehicle, for direct placement in the periodontal pocket for the treatment of chronic periodontitis.
Among various drug delivery systems for treating periodontitis, gel formulations have some advantages. Despite a relatively faster release of the drug, gels can be more easily prepared and administered. Moreover, they possess a higher bio compatibility and bio adhesivity, by allowing adhesion to the mucosa in the dental pocket and by decreasing the risk of dilution of the material by saliva.
Keeping the above facts in mind, the goals of this study were to (1) evaluate in situ gel as a vehicle in a local drug delivery system, (2) evaluate the efficacy of moxifloxacin for local drug delivery, (3) evaluate the efficacy of gellan gum for in situ gelation of moxifloxacin, and (4) evaluate and compare the clinical and microbiological parameters of moxifloxacin with those of the gold standard, chlorhexidine di gluconate.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Moxifloxacin, Chronic periodontitis | Experimental | Drug: Moxifloxacin50 micrograms Moxifloxacin |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients with good systemic health
- Patients with Chronic periodontitis with sites with probing pocket depth (PPD) of ≥ 5 mm
- a minimum of 12 natural teeth with radiographic evidence of bone loss
- willingness to comply with the study protocol.
Key exclusion criteria (3 listed)
- Patients with a history of drug allergy to quinolones or those who were taking medication that might interact with moxifloxacin
- Patients with history of antibiotic coverage in the 6 months preceding the study
- Pregnant or lactating patients.
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 |
|---|---|---|
| MoxifloxacinAlso: AveloxTO ASSESS THE EFFICACY OF MOXIFLOXACIN IN SITU GEL IN THE TREATMENT OF PERIODONTAL POCKET. | Drug | Moxifloxacin, Chronic periodontitis |
Primary outcome
Change from baseline in Clinical attachment level at 3 months in chronic periodontitis patients
Time frame: 3 months
The present randomized clinical trial assessed the effects of moxifloxacin, compared with chlorhexidine, locally administered via in situ gel formulation, on various clinical parameters describing periodontitis.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2020.
- Background: PubMed 18834244Guentsch A, Jentsch H, Pfister W, Hoffmann T, Eick S. Moxifloxacin as an adjunctive antibiotic in the treatment of severe chronic periodontitis. J Periodontol. 2008 Oct;79(10):1894-903. doi: 10.1902/jop.2008.070493.
Related trials for Chronic Generalized Periodontitis
RecruitingPhase 2
3-Month Clinical Trial of Liquid S-PRF in Periodontal Debridement for Periodontitis Stages II-IV
Periodontitis Stage II, Periodontitis Stage III
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.
Shaurya Manjunath, MDS principal investigator
Rajiv Gandhi University of Health Sceinces, Bangalore,Karnataka, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Moxifloxacin in people with Chronic Generalized Periodontitis, run by Sri Hasanamba Dental College and Hospital at 1 site in India.
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 3 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: finished, as of the sponsor's last update on 13 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Clinical attachment level at 3 months in chronic periodontitis patients (time frame: 3 months). 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 NCT02016157, which also lists 1 linked publication.
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 13 Aug 2020.