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Trial · NCT01079663

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

NCT01079663, Phase 2, Completed, Dexcel Pharma Technologies Ltd.; results first posted 2021-06-15

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. The Efficacy and Safety of Chlorhexidine Gluconate Chip (Periochip®) in Therapy of Symptoms in Patients With Peri-implantitis. Trials, record NCT01079663. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01079663

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
The Efficacy and Safety of Chlorhexidine Gluconate Chip (Periochip®) in Therapy of Symptoms in Patients With Peri-implantitis
NCT number
NCT01079663
Status
Completed
Phases
Phase 2
Enrollment
60 participants, actual
Lead sponsor
Dexcel Pharma Technologies Ltd.
Conditions
Peri-implantitis
Interventions
Chlorhexidine 2.5 mg, Placebo chip
First posted
2010-03-03
Last updated
2021-06-15
Results first posted
2021-06-15

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryChange in Mean Probing Pocket Depth (PPD) for Selected Target PocketBaseline 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
SecondaryClinical Attachment Levels (CAL)Baseline to Week 24
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
SecondaryBleeding on Probing (BOP)Baseline to Week 24BOP 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

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYChange in Mean Probing Pocket Depth (PPD) for Selected Target PocketBaseline to Week 24mmMEAN
SECONDARYClinical Attachment Levels (CAL)Baseline to Week 24mmMEAN
SECONDARYBleeding on Probing (BOP)Baseline to Week 24Target implantCOUNT_OF_UNITS

Results by group6

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Change in Mean Probing Pocket Depth (PPD) for Selected Target PocketChlorhexidine Chip (Periochip®)-2.13Standard Deviation 1.399mm
Change in Mean Probing Pocket Depth (PPD) for Selected Target PocketPlacebo Chip-1.79Standard Deviation 1.149mm
Clinical Attachment Levels (CAL)Chlorhexidine Chip (Periochip®)-2.18Standard Deviation 1.394mm
Clinical Attachment Levels (CAL)Placebo Chip-1.76Standard Deviation 1.257mm
Bleeding on Probing (BOP)Chlorhexidine Chip (Periochip®)23Target implant
Bleeding on Probing (BOP)Placebo Chip16Target implant

Participant flow6

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDChlorhexidine Chip (Periochip®)30
Overall StudySTARTEDPlacebo Chip30
Overall StudyCOMPLETEDChlorhexidine Chip (Periochip®)30
Overall StudyCOMPLETEDPlacebo Chip26
Overall StudyNOT COMPLETEDChlorhexidine Chip (Periochip®)0
Overall StudyNOT COMPLETEDPlacebo Chip4

Adverse events24

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEvents
otherAphthous ulcerGastrointestinal disordersChlorhexidine Chip (Periochip®)130
otherAphthous ulcerGastrointestinal disordersPlacebo Chip230
otherGingival swellingGastrointestinal disordersChlorhexidine Chip (Periochip®)330
otherGingival swellingGastrointestinal disordersPlacebo Chip030
otherPeriodontal diseaseGastrointestinal disordersChlorhexidine Chip (Periochip®)330
otherPeriodontal diseaseGastrointestinal disordersPlacebo Chip030
otherPeriodontal inflammationGastrointestinal disordersChlorhexidine Chip (Periochip®)030
otherPeriodontal inflammationGastrointestinal disordersPlacebo Chip330
otherToothacheGastrointestinal disordersChlorhexidine Chip (Periochip®)030
otherToothacheGastrointestinal disordersPlacebo Chip230

Adverse event totals6

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityChlorhexidine Chip (Periochip®)030
Total, all-cause mortalityPlacebo Chip030
Total, other adverse eventsChlorhexidine Chip (Periochip®)1530
Total, other adverse eventsPlacebo Chip1630
Total, serious adverse eventsChlorhexidine Chip (Periochip®)030
Total, serious adverse eventsPlacebo Chip230

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

ComparisonSource
Chlorhexidine Chip (Periochip®) vs Placebo Chip: deaths from any causeTrial comparisons
Chlorhexidine Chip (Periochip®) vs Placebo Chip: serious adverse eventsTrial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01079663

GET https://conductscience.org/api/trials/v1/NCT01079663/events?page=2