Peri-implantitisPhase 2NCT01079663

The Efficacy and Safety of Chlorhexidine Gluconate Chip (Periochip®) in Therapy of Symptoms in Patients With Peri-implantitis

A Phase 2 study testing Chlorhexidine 2.5 mg in people with Peri-implantitis, run by Dexcel Pharma Technologies Ltd. at 2 sites in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of the study is to assess the efficacy and the safety of Chlorhexidine Gluconate chip (Periochip®) versus Placebo Chip in treatment of symptoms in patients with Peri-Implantitis. Read more about this study

Who is it for?: Ages 21 years and older
Conditions the study is for: Peri-implantitis
What is being tested?: Chlorhexidine 2.5 mg
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 60 participants
Where: 2 sitesIsrael
Study dates: Mar 2010to Nov 2011
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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.
Peri-implantitis is characterized by the presence of at least 1 implant with periodontal pockets of 6-10 mm in depth (potential target implant) demonstrating Bleeding on Probing without involving the apex of the implant and confirmed radiographically.
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

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 impinges on the tissues being assessed.
Presence of soft or hard tissue tumours of the oral cavity.
Horizontal inter implant distance ≤2 mm (if an adjacent implant exists).
Selection of the following dental implant types as target implant/s: hydroxylapatite (HA) and/or Titanium Plasma-sprayed (TPS).
History of allergy to Chlorhexidine.

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Patients treated with systemic antibiotic therapy or periodontal/mechanical/local delivery therapy within 6 weeks prior to study entry and throughout the study duration.
Patients treated with non-steroidal anti-inflammatory drugs (NSAIDs) within 14 days prior to entry into the study and throughout the study duration (excluding treatment of acetylsalicylic acid ≤100 mg /day).
Patients taking Phenytoin, calcium channel blockers drugs (CCBs) and/or cyclosporine, which might influence the pattern of tissue response.
Presence of any of the following conditions: Type 1 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.
Patient uses Chlorhexidine oral rinses/ mouthwashes on a regular basis.

Trial locations and contacts

2 sites in 1 country.

Israel2 sites

Department of Periodontology, School of Graduate Dentistry, Rambam Health Care Center
Haifa
The Oral & Maxillofacial Surgery Unit of the Tel Aviv Medical Center
Tel Aviv

Other trials in Israel

About this study

The purpose of the study is to assess the efficacy and the safety of Chlorhexidine Gluconate chip (Periochip®) versus Placebo Chip in treatment of symptoms in patients with Peri-Implantitis.

Read the detailed description

This is a Phase 2a study assessing the safety and efficacy of Chlorhexidine Gluconate chip (Periochip®) versus Placebo Chip in treatment of symptoms in patients with Peri-Implantitis

Conditions: Peri-implantitis
Being tested: Chlorhexidine 2.5 mg, Placebo chip
Medical subject headings: Peri-Implantitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Chlorhexidine 2.5 mgDrug
Placebo chipDrug

Study groups in NCT01079663
Study group	Role	What they receive
Chlorhexidine chip (Periochip®)	Experimental	PerioChip®, consisting of 2.5 mg Chlorhexidine Gluconate PerioChips were inserted only to target pockets whose pocket depth (PD) at Baseline visit (Week 0), Week 2, Week 4, Week 6, Week 8, Week 12 and Week 18 was ≥ 6 mm Receives: Drug: Chlorhexidine 2.5 mg
Placebo chip	Placebo comparator	Placebo Chip Placebo Chips were inserted only to target pockets whose pocket depth (PD) at Baseline visit (Week 0), Week 2, Week 4, Week 6, Week 8, Week 12 and Week 18 was ≥ 6 mm Receives: Drug: Placebo chip

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Mean Probing Pocket Depth (PPD) for Selected Target Pocket
Pocket depth is the measurement of the distance from the coronal edge of the gingival margin to the base of the pocket. Measurements were taken with a standard 15-mm University of North Carolina (UNC) periodontal probe.
Change from baseline in PPD was calculated as Week 24 PPD minus Baseline PPD such that a negative difference indicates an improvement in condition
Measured: Baseline to Week 24

Secondary outcomes (2)

Clinical Attachment Levels (CAL)
Loss of attachment is defined as the distance in millimetres that the base of the pocket has migrated apically from the gingival margin of the crown. CAL was calculated at the same site that PPD was measured
Measured: Baseline to Week 24
Bleeding on Probing (BOP)
BOP was measured at the same site after measuring the PPD. The scoring system used for recording the BOP was a dichotomous one:
0 = No bleeding
1 = Bleeding on probing of the pocket base
Measured: Baseline to Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2010Nov 2011

First posted3 Mar 2010 (estimated)
Study startMar 2010
Primary completionOct 2011
Study completionNov 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Peri-implantitisStudies 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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01079663
Sponsor's protocol ID: CLI/013P
Status last verified: May 2021
First submitted: 2 Mar 2010
Last updated: 15 Jun 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Diagnostic Accuracy of Large Language Models for Peri-Implant Marginal Bone Loss on Panoramic Radiographs
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ATR-FTIR and Raman Spectroscopy of Peri-Implant Crevicular Fluid in Peri-Implantitis
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All Peri-implantitis trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Efficacy and Safety of Chlorhexidine Gluconate Chip (Periochip®) in Therapy of Symptoms in Patients With Peri-implantitis
ClinicalTrials.gov ID: NCT01079663
Acronym / sponsor ID: CLI/013P
Conditions: Peri-implantitis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Dexcel Pharma Technologies Ltd.Industry (pharma, biotech, devices)
Study start: Mar 2010
Primary completion: Oct 2011 (actual)
Study completion: Nov 2011 (actual)
First posted: 3 Mar 2010 (estimated)
Results: Posted 15 Jun 2021

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 the efficacy and the safety of Chlorhexidine Gluconate chip (Periochip®) versus Placebo Chip in treatment of symptoms in patients with Peri-Implantitis.

Detailed description

This is a Phase 2a study assessing the safety and efficacy of Chlorhexidine Gluconate chip (Periochip®) versus Placebo Chip in treatment of symptoms in patients with Peri-Implantitis

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Chlorhexidine chip (Periochip®)	Experimental	Drug: Chlorhexidine 2.5 mgPerioChip®, consisting of 2.5 mg Chlorhexidine Gluconate PerioChips were inserted only to target pockets whose pocket depth (PD) at Baseline visit (Week 0), Week 2, Week 4, Week 6, Week 8, Week 12 and Week 18 was ≥ 6 mm
Placebo chip	Placebo comparator	Drug: Placebo chipPlacebo Chip Placebo Chips were inserted only to target pockets whose pocket depth (PD) at Baseline visit (Week 0), Week 2, Week 4, Week 6, Week 8, Week 12 and Week 18 was ≥ 6 mm

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.
Peri-implantitis is characterized by the presence of at least 1 implant with periodontal pockets of 6-10 mm in depth (potential target implant) demonstrating Bleeding on Probing without involving the apex of the implant and confirmed radiographically.

Key exclusion criteria (13 listed)

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 impinges on the tissues being assessed.
Presence of soft or hard tissue tumours of the oral cavity.
Horizontal inter implant distance ≤2 mm (if an adjacent implant exists).
Selection of the following dental implant types as target implant/s: hydroxylapatite (HA) and/or Titanium Plasma-sprayed (TPS).

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
Chlorhexidine 2.5 mg	Drug	Chlorhexidine chip (Periochip®)
Placebo chip	Drug	Placebo chip

Primary outcome

Change in Mean Probing Pocket Depth (PPD) for Selected Target Pocket
Time frame: Baseline to Week 24
Pocket depth is the measurement of the distance from the coronal edge of the gingival margin to the base of the pocket. Measurements were taken with a standard 15-mm University of North Carolina (UNC) periodontal probe. Change from baseline in PPD was calculated as Week 24 PPD minus Baseline PPD such that a negative difference indicates an improvement in condition

2 secondary outcomes

Clinical Attachment Levels (CAL)
Time frame: Baseline to Week 24
Bleeding on Probing (BOP)
Time frame: Baseline to Week 24

Results and safety

Results posted to the registry on 15 Jun 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Chlorhexidine Chip (Periochip®)	30	30
Placebo Chip	30	26

Primary outcome: Change in Mean Probing Pocket Depth (PPD) for Selected Target Pocket

Time frame: Baseline to Week 24. Mean (Standard Deviation). Unit: mm

Measure	Chlorhexidine Chip (Periochip®) n = 30	Placebo Chip n = 30
Value	-2.13 (1.399)	-1.79 (1.149)

Chlorhexidine Chip (Periochip®) vs Placebo Chip: Mean Difference (Final Values): -0.49 (95% CI -1.19 to 0.20), p = 0.1629, Mixed Models Analysis

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline through Week 24. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Chlorhexidine Chip (Periochip®)	0 of 30 (0%)	15 of 30 (50%)	0 of 30
Placebo Chip	2 of 30 (6.7%)	16 of 30 (53.3%)	0 of 30

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Peri-implantitis

Not yet recruiting
Effect of Customized Versus Stock Healing Abutments on Peri-Implant Soft Tissue
Peri-Implantitis
RecruitingObservational study
Evaluation of 25(OH)D3 and LL-37 Levels in Periimplant Sulcus Fluid
Peri Implantitis, Peri Implant Mucositis
Not yet recruitingObservational study
Diagnostic Accuracy of Large Language Models for Peri-Implant Marginal Bone Loss on Panoramic Radiographs
Peri-implantitis, Alveolar Bone Loss
RecruitingObservational study
Access to Probing and Peri-implant Diseases
Peri-implantitis, Peri-implant Bone Loss
Not yet recruitingObservational study
ATR-FTIR and Raman Spectroscopy of Peri-Implant Crevicular Fluid in Peri-Implantitis
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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.

The record lists no contact. Use the official record to reach the sponsor.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Chlorhexidine 2.5 mg in people with Peri-implantitis, run by Dexcel Pharma Technologies Ltd. at 2 sites 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 13 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 15 Jun 2021. 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 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 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?

Yes. Results are posted in the registry (first posted 15 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 in Mean Probing Pocket Depth (PPD) for Selected Target Pocket (time frame: Baseline to Week 24). 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 NCT01079663.

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 15 Jun 2021.