PeriodontitisPhase 2NCT01040286
The Efficacy and Safety of Flurbiprofen Chip Versus Chlorhexidine Chip (Periochip®) in Therapy of Adult Chronic Periodontitis
A Phase 2 study testing Flurbiprofen and Chlorhexidine in people with Periodontitis, run by Dexcel Pharma Technologies Ltd. at 1 site in Israel.
Trial summary
The purpose of the study is to assess efficacy and safety of Flurbiprofen Chip versus Chlorhexidine chip (Periochip®) in therapy of adult chronic periodontitis. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Periodontitis
- What is being tested?
- Flurbiprofen and Chlorhexidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteIsrael
- Study dates
- Aug 2009to Jun 2010
- Phase
- Phase 2
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed and dated informed consent form
- Good general health
- Male or female subjects aged >21 years old
- Availability for the 9 week duration of the study
- Chronic periodontal disease on natural teeth characterized by the presence of at least 2 teeth with periodontal pockets of 5-9 mm in depth (potential target teeth) demonstrating bleeding on probing without involving the apex of the tooth and confirmed by dental X-ray.
- Females of childbearing potential must be non-pregnant and non-lactating at entry and agree to use an adequate method (Oral or parenteral hormonal contraceptive; Intrauterine device; barrier and spermicide) of birth control during the study.
Who cannot join
- An existing aggressive periodontitis.
- Presence of oral local mechanical factors that could (in the opinion of the investigator) influence the outcome of the study.
- Presence of orthodontic appliances, or any removable appliances, that impinge on the tissues being assessed.
- Soft or hard tissue tumours of the oral cavity.
- Presence of dental implant adjacent to target tooth.
- Presence of more than 2 adjacent periodontal pockets on the same potential target tooth.
Show all 15Show fewer
- Periodontal pockets of more than 9 mm in depth, and/or with class 2 or 3 furcation involvement, on the potential target tooth.
- Systemic antibiotic therapy or periodontal/mechanical/local delivery therapy within 6 weeks prior to study entry and throughout the study duration.
- History of allergy to chlorhexidine, flurbiprofen or to other non-steroidal anti-inflammatory drugs (NSAIDs).
- Subjects taking Phenytoin, calcium channel blockers drugs (CCBs) and/or cyclosporine, which might influence the pattern of tissue response.
- Subjects treated with non-steroidal anti-inflammatory drugs (NSAIDs) within 14 days prior to entry into the study and throughout the study duration.
- Presence of the following conditions: Type 1 diabetes, major recurrent aphtae, stomatitis, abscesses and related oral pathologies.
- The presence of any medical or psychiatric condition that in the opinion of the investigator could affect the successful participation of the subject in the study.
- Subject participates in any other clinical study 30 days prior to the start of the study and throughout the study duration.
- Subject uses chlorhexidine oral rinses/ mouthwashes on a regular basis.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Department of Periodontology, School of Graduate Dentistry, Rambam Health Care Center
Haifa, 9602
About this study
The purpose of the study is to assess efficacy and safety of Flurbiprofen Chip versus Chlorhexidine chip (Periochip®) in therapy of adult chronic periodontitis.
- Conditions
- Periodontitis
- Being tested
- Flurbiprofen, Chlorhexidine
- Keywords
- Subjects, age>21, with Chronic periodontal disease on natural teeth characterized by the presence of at least 2 teeth with periodontal, pockets of 5-9 mm in depth demonstrating bleeding on probing without involving the, apex of the tooth and confirmed by dental X-ray.
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FlurbiprofenDrug
2.0 mg
ChlorhexidineDrug
2.5mg
| Study group | Role | What they receive |
|---|---|---|
| Flurbiprofen Chip | Experimental | Not described Receives: Drug: Flurbiprofen |
| Chlorhexidine chip | Active comparator | Not described Receives: Drug: Chlorhexidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Probing Pocket Depth reduction
Measured: 8 weeks
Secondary outcomes (1)
clinical attachment levels (CAL) and bleeding on probing (BOP)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2009 (estimated)
- Study startAug 2009
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
Sponsor and investigators
- Lead sponsor
- Dexcel Pharma Technologies Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01040286
- Sponsor's protocol ID
- CLI/012F
- Status last verified
- Jul 2010
- First submitted
- 27 Dec 2009
- Last updated
- 7 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Flurbiprofen Chip Versus Chlorhexidine Chip (Periochip®) in Therapy of Adult Chronic Periodontitis
- ClinicalTrials.gov ID
- NCT01040286
- Acronym / sponsor ID
- CLI/012F
- Conditions
- Periodontitis
- Keywords
- Subjects, age>21, with Chronic periodontal disease on natural teeth characterized by the presence of at least 2 teeth with periodontal, pockets of 5-9 mm in depth demonstrating bleeding on probing without involving the, apex of the tooth and confirmed by dental X-ray.
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Dexcel Pharma Technologies Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2009
- Study completion
- Jun 2010 (actual)
- First posted
- 29 Dec 2009 (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.
The purpose of the study is to assess efficacy and safety of Flurbiprofen Chip versus Chlorhexidine chip (Periochip®) in therapy of adult chronic periodontitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Flurbiprofen Chip | Experimental | Drug: Flurbiprofen |
| Chlorhexidine chip | Active comparator | Drug: Chlorhexidine |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Signed and dated informed consent form
- Good general health
- Male or female subjects aged >21 years old
- Availability for the 9 week duration of the study
- Chronic periodontal disease on natural teeth characterized by the presence of at least 2 teeth with periodontal pockets of 5-9 mm in depth (potential target teeth) demonstrating bleeding on probing without involving the apex of the tooth and confirmed by dental X-ray.
Key exclusion criteria (15 listed)
- An existing aggressive periodontitis.
- Presence of oral local mechanical factors that could (in the opinion of the investigator) influence the outcome of the study.
- Presence of orthodontic appliances, or any removable appliances, that impinge on the tissues being assessed.
- Soft or hard tissue tumours of the oral cavity.
- Presence of dental implant adjacent to target tooth.
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 |
|---|---|---|
| Flurbiprofen2.0 mg | Drug | Flurbiprofen Chip |
| Chlorhexidine2.5mg | Drug | Chlorhexidine chip |
Primary outcome
Mean Probing Pocket Depth reduction
Time frame: 8 weeks
1 secondary outcome
clinical attachment levels (CAL) and bleeding on probing (BOP)
Time frame: 8 weeks
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 7 Jul 2010.
Related trials for Periodontitis
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
Active, not recruitingObservational study
A Retrospective Comparative Evaluation of Omega-3 and Resveratrol Supplementation in Patients With Periodontitis
Periodontitis
Recruiting
Probiotics Versus Antibiotics as an Adjuvant to Non-surgical Periodontal Treatment Among Smokers With Stage II, Grade B Periodontitis
Probiotics, Antibiotics
Recruiting
Effects of Different Activation Techniques on Antimicrobial Photodynamic Therapy in Apical Periodontitis
Apical Periodontitis, Endodontic Retreatment
Recruiting
Ozone Gel Versus Chlorohexidine Gel as an Adjunct to Non-Surgical Treatment of Stage II Periodontitis Grade B Among Smokers Patients
Ozone Gel, Chlorohexidine Gel
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Flurbiprofen and Chlorhexidine in people with Periodontitis, run by Dexcel Pharma Technologies Ltd. at 1 site in Israel.
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 6 inclusion and 15 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 7 Jul 2010. 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 Israel. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Mean Probing Pocket Depth reduction (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jul 2010.