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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dexcel Pharma Technologies Ltd.
ClinicalTrials.gov Identifier:
NCT01079663
First received: March 2, 2010
Last updated: November 14, 2011
Last verified: November 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Peri-implantitis
 Drug: Chlorhexidine 2.5 mg
Drug: Placebo chip
 Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: The Efficacy and Safety of Chlorhexidine Gluconate Chip (Periochip®) in Therapy of Symptoms in Patients With Peri-implantitis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Dexcel Pharma Technologies Ltd.:

Primary Outcome Measures:
  • Mean probing pocket depth reduction [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Clinical attachment levels (CAL) [ Designated as safety issue: Yes ]
  • Bleeding on probing (BOP) [ Designated as safety issue: Yes ]

Study Start Date: March 2010
Study Completion Date: November 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Chlorhexidine chip (Periochip®) Drug: Chlorhexidine 2.5 mg
Placebo Comparator: Placebo chip Drug: Placebo chip

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Signed and dated Informed Consent Form.
  2. Good general health.
  3. Male or female patients aged >21 years old.
  4. Availability for the 25 week duration of the study.
  5. 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.
  6. 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.

Exclusion Criteria:

  1. Presence of oral local mechanical factors that could (in the opinion of the Investigator) influence the outcome of the study.
  2. Presence of orthodontic appliances, or any removable appliances, that impinges on the tissues being assessed.
  3. Presence of soft or hard tissue tumours of the oral cavity.
  4. Horizontal inter implant distance ≤2 mm (if an adjacent implant exists).
  5. Selection of the following dental implant types as target implant/s: hydroxylapatite (HA) and/or Titanium Plasma-sprayed (TPS).
  6. History of allergy to Chlorhexidine.
  7. Patients treated with systemic antibiotic therapy or periodontal/mechanical/local delivery therapy within 6 weeks prior to study entry and throughout the study duration.
  8. 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).
  9. Patients taking Phenytoin, calcium channel blockers drugs (CCBs) and/or cyclosporine, which might influence the pattern of tissue response.
  10. Presence of any of the following conditions: Type 1 diabetes, major recurrent aphtae stomatitis, abscesses and related oral pathologies.
  11. 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.
  12. Patient participates in any other clinical study 30 days prior to the start of the study and throughout the study duration.
  13. Patient uses Chlorhexidine oral rinses/ mouthwashes on a regular basis.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01079663

Locations
Israel
Department of Periodontology, School of Graduate Dentistry, Rambam Health Care Center
Haifa, Israel
The Oral & Maxillofacial Surgery Unit of the Tel Aviv Medical Center
Tel Aviv, Israel
Sponsors and Collaborators
Dexcel Pharma Technologies Ltd.
  More Information

No publications provided

Responsible Party: Dexcel Pharma Technologies Ltd.
ClinicalTrials.gov Identifier: NCT01079663     History of Changes
Other Study ID Numbers: CLI/013P
Study First Received: March 2, 2010
Last Updated: November 14, 2011
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Peri-Implantitis
Mouth Diseases
Stomatognathic Diseases
Periodontal Diseases
Chlorhexidine
Chlorhexidine gluconate
 Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Disinfectants
Dermatologic Agents

ClinicalTrials.gov processed this record on June 18, 2013