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The Efficacy and Safety of PerioChip Plus (Flurbiprofen/Chlorhexidine) Formulation in the Therapy of Adult Periodontitis

Primary Purpose

Periodontitis

Status
Completed
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
PerioChip Plus (Flurbiprofen +Chlorhexidine ), Flurbiprofen Chip, PerioChip (Chlorhexidine ) and Placebo Chip
Sponsored by
Dexcel Pharma Technologies Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontitis focused on measuring Periodontitis, Dental Care, Efficacy, Safety

Eligibility Criteria

25 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Signed informed consent form
  • Good general health
  • Male or female subjects aged >25 years old
  • Minimum of 8 natural teeth
  • Availability for the 25 weeks duration of the study
  • Periodontal disease on a natural teeth characterized by the presence of at least 2 teeth with periodontal pockets of 6-9 mm in depth (target teeth) in order to reach baseline (day 1) with periodontal pockets of 5-8 mm in depth, without involving the apex of the tooth.
  • Females of childbearing potential must be non pregnant at entry and agree to use an adequate method of birth control during the study.
  • Demonstrate bleeding on probing to the base of the pocket at the pockets (sites) selected at the time of screening.

Exclusion Criteria:

  • Presence of oral local mechanical factors that could (in the opinion of the investigator) influences the outcome of the study.
  • Presence of orthodontic appliances or any removable appliance that impinges on the tissues being assessed.
  • Soft or hard tissue tumours of the oral cavity.
  • Presence of dental implant adjacent to target tooth.
  • Periodontal pockets of more than 9 mm in depth.
  • General systemic antibiotics therapy or periodontal/mechanical/local delivery therapy within 6 weeks prior to study entry and through out the study duration.
  • History of allergy to chlorhexidine, flurbiprofen or to other non-steroidal anti-inflammatory drugs (NSAIDs).
  • Subjects taking diphenylhydantoin, nifedepine and/or cyclosporine, which might influence the pattern of tissue response.
  • Subject treated with non-steroidal anti-inflammatory drugs (NSAIDs) within 14 days prior to entry into the study and through out the study duration.
  • Pregnant women or those planning to become pregnant or lactating women.
  • Presence of the following conditions: Type 1 diabetes, major recurrent aphtae, stomatitis 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 subject in the study.
  • Subject participates in any other clinical study 30 days prior to the start of the study and through out the study duration.
  • Subject uses chlorhexidine oral rinses/ mouthwashes on a regular basis.

Sites / Locations

  • Hadassah Medical Organization

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Placebo Comparator

Arm Label

PerioChip Plus

Flurbiprofen Chip

PerioChip

Placebo Chip

Arm Description

Outcomes

Primary Outcome Measures

At 24 weeks, relative to baseline, the mean reductions in probing pocket depth (PPD) will be used as primary efficacy endpoint. Additional primary endpoints are clinical attachment levels (CAL) and bleeding on probing (BOP) in the target pockets selected

Secondary Outcome Measures

PPD measurements at 6, 12 and 18 weeks will be used as secondary endpoints. Additional secondary endpoints are clinical attachment levels (CAL) and bleeding on probing (BOP) in the target pockets selected at screening, measured at weeks 6, 12 and 18.

Full Information

First Posted
January 21, 2007
Last Updated
June 13, 2011
Sponsor
Dexcel Pharma Technologies Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00425451
Brief Title
The Efficacy and Safety of PerioChip Plus (Flurbiprofen/Chlorhexidine) Formulation in the Therapy of Adult Periodontitis
Official Title
The Efficacy and Safety of PerioChip Plus (Flurbiprofen/Chlorhexidine) Formulation in the Therapy of Adult Periodontitis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Dexcel Pharma Technologies Ltd.

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to determine the effect of the placement of a PerioChip Plus (flurbiprofen/chlorhexidine - FBP/CHX) formulation versus PerioChip (chlorhexidine) formulation versus Flurbiprofen Chip formulation versus Placebo Chip formulation on probing pocket depth (PPD)
Detailed Description
This is an 80 subjects, single-center, randomized, double-blinded, parallel, 4-arm clinical study (25 subjects in the PerioChip Plus and PerioChip arms and 15 subjects in the Flurbiprofen Chip and Placebo Chip arms). At 24 weeks, relative to baseline, the mean reductions in probing pocket depth (PPD) will be used as primary efficacy endpoint. Additional primary endpoints are clinical attachment levels (CAL) and bleeding on probing (BOP) in the target pockets selected at screening, measured at weeks 24. PPD measurements at 6, 12 and 18 weeks will be used as secondary endpoints. Additional secondary endpoints are clinical attachment levels (CAL) and bleeding on probing (BOP) in the target pockets selected at screening, measured at weeks 6, 12 and 18.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis
Keywords
Periodontitis, Dental Care, Efficacy, Safety

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PerioChip Plus
Arm Type
Experimental
Arm Title
Flurbiprofen Chip
Arm Type
Experimental
Arm Title
PerioChip
Arm Type
Active Comparator
Arm Title
Placebo Chip
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
PerioChip Plus (Flurbiprofen +Chlorhexidine ), Flurbiprofen Chip, PerioChip (Chlorhexidine ) and Placebo Chip
Primary Outcome Measure Information:
Title
At 24 weeks, relative to baseline, the mean reductions in probing pocket depth (PPD) will be used as primary efficacy endpoint. Additional primary endpoints are clinical attachment levels (CAL) and bleeding on probing (BOP) in the target pockets selected
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
PPD measurements at 6, 12 and 18 weeks will be used as secondary endpoints. Additional secondary endpoints are clinical attachment levels (CAL) and bleeding on probing (BOP) in the target pockets selected at screening, measured at weeks 6, 12 and 18.
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Signed informed consent form Good general health Male or female subjects aged >25 years old Minimum of 8 natural teeth Availability for the 25 weeks duration of the study Periodontal disease on a natural teeth characterized by the presence of at least 2 teeth with periodontal pockets of 6-9 mm in depth (target teeth) in order to reach baseline (day 1) with periodontal pockets of 5-8 mm in depth, without involving the apex of the tooth. Females of childbearing potential must be non pregnant at entry and agree to use an adequate method of birth control during the study. Demonstrate bleeding on probing to the base of the pocket at the pockets (sites) selected at the time of screening. Exclusion Criteria: Presence of oral local mechanical factors that could (in the opinion of the investigator) influences the outcome of the study. Presence of orthodontic appliances or any removable appliance that impinges on the tissues being assessed. Soft or hard tissue tumours of the oral cavity. Presence of dental implant adjacent to target tooth. Periodontal pockets of more than 9 mm in depth. General systemic antibiotics therapy or periodontal/mechanical/local delivery therapy within 6 weeks prior to study entry and through out the study duration. History of allergy to chlorhexidine, flurbiprofen or to other non-steroidal anti-inflammatory drugs (NSAIDs). Subjects taking diphenylhydantoin, nifedepine and/or cyclosporine, which might influence the pattern of tissue response. Subject treated with non-steroidal anti-inflammatory drugs (NSAIDs) within 14 days prior to entry into the study and through out the study duration. Pregnant women or those planning to become pregnant or lactating women. Presence of the following conditions: Type 1 diabetes, major recurrent aphtae, stomatitis 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 subject in the study. Subject participates in any other clinical study 30 days prior to the start of the study and through out the study duration. Subject uses chlorhexidine oral rinses/ mouthwashes on a regular basis.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aubrey Soskolne, Professor
Organizational Affiliation
Hadassah Medical Organization IRB
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hadassah Medical Organization
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel

12. IPD Sharing Statement

Learn more about this trial

The Efficacy and Safety of PerioChip Plus (Flurbiprofen/Chlorhexidine) Formulation in the Therapy of Adult Periodontitis

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