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OpenTrials
Completed

NCT Number: NCT01249846

The Efficacy and Safety of 2.5 mg Chlorhexidine Gluconate Chip (PerioChip®) in Frequent Treatment Versus Routine Treatment in Therapy of Adult Chronic Periodontitis

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.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Department of Periodontology, School of Graduate Dentistry, Rambam Health Care Center

Haifa, 9602, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

PerioChip ®

Drug

Sponsors and collaborators

Lead sponsor

Dexcel Pharma Technologies Ltd.

Industry

Registry information

Important dates

Study start
2010
First posted
Nov 30, 2010
Registry last updated
Jan 17, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.