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
Cite this record
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
On this page
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.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Mean Probing Pocket Depth (PPD) for Selected Target Pocket | 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 |
| Secondary | Clinical 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 |
| Secondary | Bleeding on Probing (BOP) | Baseline to Week 24 | 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 |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Mean Probing Pocket Depth (PPD) for Selected Target Pocket | Baseline to Week 24 | mm | MEAN | |
| SECONDARY | Clinical Attachment Levels (CAL) | Baseline to Week 24 | mm | MEAN | |
| SECONDARY | Bleeding on Probing (BOP) | Baseline to Week 24 | Target implant | COUNT_OF_UNITS |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Mean Probing Pocket Depth (PPD) for Selected Target Pocket | Chlorhexidine Chip (Periochip®) | -2.13 | Standard Deviation 1.399 | mm | |
| Change in Mean Probing Pocket Depth (PPD) for Selected Target Pocket | Placebo Chip | -1.79 | Standard Deviation 1.149 | mm | |
| Clinical Attachment Levels (CAL) | Chlorhexidine Chip (Periochip®) | -2.18 | Standard Deviation 1.394 | mm | |
| Clinical Attachment Levels (CAL) | Placebo Chip | -1.76 | Standard Deviation 1.257 | mm | |
| Bleeding on Probing (BOP) | Chlorhexidine Chip (Periochip®) | 23 | Target implant | ||
| Bleeding on Probing (BOP) | Placebo Chip | 16 | Target implant |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Chlorhexidine Chip (Periochip®) | 30 | |
| Overall Study | STARTED | Placebo Chip | 30 | |
| Overall Study | COMPLETED | Chlorhexidine Chip (Periochip®) | 30 | |
| Overall Study | COMPLETED | Placebo Chip | 26 | |
| Overall Study | NOT COMPLETED | Chlorhexidine Chip (Periochip®) | 0 | |
| Overall Study | NOT COMPLETED | Placebo Chip | 4 |
Source ClinicalTrials.gov
Adverse events24
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Aphthous ulcer | Gastrointestinal disorders | Chlorhexidine Chip (Periochip®) | 1 | 30 | |
| other | Aphthous ulcer | Gastrointestinal disorders | Placebo Chip | 2 | 30 | |
| other | Gingival swelling | Gastrointestinal disorders | Chlorhexidine Chip (Periochip®) | 3 | 30 | |
| other | Gingival swelling | Gastrointestinal disorders | Placebo Chip | 0 | 30 | |
| other | Periodontal disease | Gastrointestinal disorders | Chlorhexidine Chip (Periochip®) | 3 | 30 | |
| other | Periodontal disease | Gastrointestinal disorders | Placebo Chip | 0 | 30 | |
| other | Periodontal inflammation | Gastrointestinal disorders | Chlorhexidine Chip (Periochip®) | 0 | 30 | |
| other | Periodontal inflammation | Gastrointestinal disorders | Placebo Chip | 3 | 30 | |
| other | Toothache | Gastrointestinal disorders | Chlorhexidine Chip (Periochip®) | 0 | 30 | |
| other | Toothache | Gastrointestinal disorders | Placebo Chip | 2 | 30 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Chlorhexidine Chip (Periochip®) | 0 | 30 |
| Total, all-cause mortality | Placebo Chip | 0 | 30 |
| Total, other adverse events | Chlorhexidine Chip (Periochip®) | 15 | 30 |
| Total, other adverse events | Placebo Chip | 16 | 30 |
| Total, serious adverse events | Chlorhexidine Chip (Periochip®) | 0 | 30 |
| Total, serious adverse events | Placebo Chip | 2 | 30 |
Source ClinicalTrials.gov
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.
| Comparison | Source |
|---|---|
| Chlorhexidine Chip (Periochip®) vs Placebo Chip: deaths from any cause | Trial comparisons |
| Chlorhexidine Chip (Periochip®) vs Placebo Chip: serious adverse events | Trial 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.
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