Trial · NCT02080403
The Efficacy and Safety of Chlorhexidine Gluconate Chip (PerioChip®) in Therapy of Peri-implantitis
NCT02080403, Phase 3, Completed, Dexcel Pharma Technologies Ltd.; results first posted 2021-06-23
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 Peri-implantitis. Trials, record NCT02080403. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02080403
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 Peri-implantitis
- NCT number
- NCT02080403
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 290 participants, actual
- Lead sponsor
- Dexcel Pharma Technologies Ltd.
- Conditions
- Peri-Implantitis
- Interventions
- 2.5 mg Chlorhexidine gluconate chip
- First posted
- 2014-03-06
- Last updated
- 2022-09-13
- Results first posted
- 2021-06-23
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Absolute Change in Mean Probing Pocket Depth for Selected Target Implants | Baseline to 6 months | Pocket depth was measured as the distance from the coronal edge of the gingival margin to the base of the pocket. It was assessed at 4 sites per implant: mesiobuccal, midbuccal, distobuccal, and midlingual. Only one of the 4 sites, usually the deepest, was determine to be target implant. |
| Secondary | Absolute Change in Mean Probing Pocket Depth of Selected Target Implants in Patients With Baseline Pocket Depth Measurement of 6-8 mm Inclusive | Baseline to 6 months | Pocket depth was measured as the distance from the coronal edge of the gingival margin to the base of the pocket. It was assessed at 4 sites per implant: mesiobuccal, midbuccal, distobuccal, and midlingual. Only one of the 4 sites, usually the deepest, was determine to be target implant. |
| Secondary | Percentage of Selected Target Implants Bleeding on Probing (BOP) | 6 months | The proportion of the change in bleeding status (bleeding to no bleeding) for the selected target implant |
| Secondary | Precentage of Selected Target Implant BOP | Week 16 | The proportion of change in bleeding status (bleeding to no bleeding) for selected target implant |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Absolute Change in Mean Probing Pocket Depth for Selected Target Implants | Baseline to 6 months | Intent to Treat | mm | MEAN |
| SECONDARY | Absolute Change in Mean Probing Pocket Depth of Selected Target Implants in Patients With Baseline Pocket Depth Measurement of 6-8 mm Inclusive | Baseline to 6 months | Intent to Treat | mm | MEAN |
| SECONDARY | Percentage of Selected Target Implants Bleeding on Probing (BOP) | 6 months | Intent to Treat | Target implant | COUNT_OF_UNITS |
| SECONDARY | Precentage of Selected Target Implant BOP | Week 16 | Target implant | COUNT_OF_UNITS |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Absolute Change in Mean Probing Pocket Depth for Selected Target Implants | Treatment | -1.69 | Standard Deviation 1.18 | mm | |
| Absolute Change in Mean Probing Pocket Depth for Selected Target Implants | Control | -1.51 | Standard Deviation 1.16 | mm | |
| Absolute Change in Mean Probing Pocket Depth of Selected Target Implants in Patients With Baseline Pocket Depth Measurement of 6-8 mm Inclusive | Treatment | -1.77 | Standard Deviation 1.25 | mm | |
| Absolute Change in Mean Probing Pocket Depth of Selected Target Implants in Patients With Baseline Pocket Depth Measurement of 6-8 mm Inclusive | Control | -1.65 | Standard Deviation 1.18 | mm | |
| Percentage of Selected Target Implants Bleeding on Probing (BOP) | Treatment | 90 | Target implant | ||
| Percentage of Selected Target Implants Bleeding on Probing (BOP) | Control | 77 | Target implant | ||
| Precentage of Selected Target Implant BOP | Treatment | 76 | Target implant | ||
| Precentage of Selected Target Implant BOP | Control | 73 | 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 | Treatment | 146 | |
| Overall Study | STARTED | Control | 144 | |
| Overall Study | COMPLETED | Treatment | 131 | |
| Overall Study | COMPLETED | Control | 132 | |
| Overall Study | NOT COMPLETED | Treatment | 15 | |
| Overall Study | NOT COMPLETED | Control | 12 |
Source ClinicalTrials.gov
Adverse events36
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 | Implant site pain | General disorders | Treatment | 12 | 146 | |
| other | Implant site pain | General disorders | Control | 0 | 144 | |
| other | Nasopharyngitis | Infections and infestations | Treatment | 5 | 146 | |
| other | Nasopharyngitis | Infections and infestations | Control | 7 | 144 | |
| other | Post procedural discomfort | Injury, poisoning and procedural complications | Treatment | 5 | 146 | |
| other | Post procedural discomfort | Injury, poisoning and procedural complications | Control | 1 | 144 | |
| other | Tooth repair | Surgical and medical procedures | Treatment | 3 | 146 | |
| other | Tooth repair | Surgical and medical procedures | Control | 2 | 144 | |
| other | Aphthous ulcer | Gastrointestinal disorders | Treatment | 3 | 146 | |
| other | Aphthous ulcer | Gastrointestinal disorders | Control | 1 | 144 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment | 0 | 146 |
| Total, all-cause mortality | Control | 2 | 144 |
| Total, other adverse events | Treatment | 43 | 146 |
| Total, other adverse events | Control | 19 | 144 |
| Total, serious adverse events | Treatment | 4 | 146 |
| Total, serious adverse events | Control | 3 | 144 |
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 |
|---|---|
| Treatment vs Control: deaths from any cause | Trial comparisons |
| Treatment vs Control: 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/NCT02080403
GET https://conductscience.org/api/trials/v1/NCT02080403/events?page=2