Generalized Adult PeriodontitisPhase 3NCT01249846
The Efficacy and Safety of 2.5 mg Chlorhexidine Gluconate Chip (PerioChip®) in Frequent Treatment Versus Routine Treatment in Therapy of Adult Chronic Periodontitis
A Phase 3 study testing PerioChip ® in people with Generalized Adult Periodontitis, run by Dexcel Pharma Technologies Ltd. at 1 site in Israel.
Trial summary
The purpose of this study is to assess the efficacy and the safety of Chlorhexidine Gluconate Chip (PerioChip®) in frequent treatment versus routine treatment 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
- Generalized Adult Periodontitis
- What is being tested?
- PerioChip ®
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- Not given
- Where
- 1 siteIsrael
- Study dates
- Dec 2010to not given
- Phase
- Phase 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 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 patients aged >21 years old.
- Availability for the 25 week duration of the study.
- Chronic periodontal disease on natural teeth
- Females of childbearing potential must be non-pregnant and non-lactating at entry and agree to use an adequate method of birth control during the study.
Who cannot join
- Oral health or factor that may influence the outcome of the study.
- History of allergy to Chlorhexidine .
- Patient uses Chlorhexidine oral rinses/mouthwashes on a regular basis.
- Patients treated with medications that may influence the outcome of the study.
- Presence of any of the following conditions: Type 1 diabetes, un-controlled type II diabetes, major recurrent aphtae stomatitis, abscesses and related oral pathologies.
- The presence of any medical or psychiatric condition or any other condition that, in the opinion of the Investigator, could affect the successful participation of the patient in the study.
- Patient participates in any other clinical study 30 days prior to the start of the study and throughout the study duration.
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 this study is to assess the efficacy and the safety of Chlorhexidine Gluconate Chip (PerioChip®) in frequent treatment versus routine treatment in therapy of adult chronic periodontitis.
- Conditions
- Generalized Adult Periodontitis
- Being tested
- PerioChip ®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PerioChip ®Drug
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Each one of the two selected periodontal pockets (target pockets) will be randomized to the Frequent PerioChip® treatment or to the Routine PerioChip®. Receives: Drug: PerioChip ® |
| Arm 2 | Placebo comparator | Each one of the two selected target pockets will be randomized to the Frequent PerioChip® treatment or to the Frequent Placebo Chip treatment. Receives: Drug: PerioChip ® |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2010 (estimated)
- Study startDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Generalized Adult 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 3
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- Dexcel Pharma Technologies Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01249846
- Sponsor's protocol ID
- CLI/015P
- Status last verified
- Jan 2013
- First submitted
- 28 Nov 2010
- Last updated
- 17 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of 2.5 mg Chlorhexidine Gluconate Chip (PerioChip®) in Frequent Treatment Versus Routine Treatment in Therapy of Adult Chronic Periodontitis
- ClinicalTrials.gov ID
- NCT01249846
- Acronym / sponsor ID
- CLI/015P
- Conditions
- Generalized Adult Periodontitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Dexcel Pharma Technologies Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2010
- First posted
- 30 Nov 2010 (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 this study is to assess the efficacy and the safety of Chlorhexidine Gluconate Chip (PerioChip®) in frequent treatment versus routine treatment in therapy of adult chronic periodontitis.
Study design
- Primary purpose
- Treatment
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: PerioChip ®Each one of the two selected periodontal pockets (target pockets) will be randomized to the Frequent PerioChip® treatment or to the Routine PerioChip®. |
| Arm 2 | Placebo comparator | Drug: PerioChip ®Each one of the two selected target pockets will be randomized to the Frequent PerioChip® treatment or to the Frequent Placebo Chip treatment. |
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 patients aged >21 years old.
- Availability for the 25 week duration of the study.
- Chronic periodontal disease on natural teeth
Key exclusion criteria (7 listed)
- Oral health or factor that may influence the outcome of the study.
- History of allergy to Chlorhexidine .
- Patient uses Chlorhexidine oral rinses/mouthwashes on a regular basis.
- Patients treated with medications that may influence the outcome of the study.
- Presence of any of the following conditions: Type 1 diabetes, un-controlled type II diabetes, major recurrent aphtae stomatitis, abscesses and related oral pathologies.
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 |
|---|---|---|
| PerioChip ® | Drug | Arm 1, Arm 2 |
Primary outcome
Not reported in the source record.
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 17 Jan 2013.
Related trials for Generalized Adult 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.
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 3 study testing PerioChip ® in people with Generalized Adult 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 7 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 17 Jan 2013. 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. Some participants in this study may receive a placebo. 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 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?
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.
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 17 Jan 2013.