Phase 3
N=290
The Efficacy and Safety of Chlorhexidine Gluconate Chip (PerioChip®) in Therapy of Peri-implantitis
Peri-Implantitis
Bottom Line
View on ClinicalTrials.gov: NCT02080403 ↗Enrolled (actual)
290
Serious AEs
2.4%
Results posted
Jun 2021
Primary outcome: Primary: Absolute Change in Mean Probing Pocket Depth for Selected Target Implants — -1.69; -1.51 mm — p=0.1159
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- 2.5 mg Chlorhexidine gluconate chip (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Dexcel Pharma Technologies Ltd.
- Primary completion
- Oct 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Absolute Change in Mean Probing Pocket Depth for Selected Target Implants |
-1.69; -1.51 | 0.1159 |
| SECONDARY Absolute Change in Mean Probing Pocket Depth of Selected Target Implants in Patients With Baseline Pocket Depth Measurement of 6-8 mm Inclusive |
-1.77; -1.65 | — |
| SECONDARY Percentage of Selected Target Implants Bleeding on Probing (BOP) |
90; 77 | — |
| SECONDARY Precentage of Selected Target Implant BOP |
76; 73 | — |
Summary
The objective of the study is to assess the efficacy and safety of PerioChip® (Chlorhexidine gluconate chip) in the treatment of patients with Peri-implantitis.
The hypothesis of the study is that PerioChip® in adjunct to mechanical subgingival debridement is more effective in the treatment of peri-implantitis when compared to the common method of mechanical subgingival debridement alone. The primary efficacy measure will be the reduction in probing pocket depth at 6 months as measured at sites of qualifying target implant.
Eligibility Criteria
Inclusion Criteria
- Good general health
- At least one implant in the oral cavity with clinical and radiographical signs of peri-implantitis. Including bone loss in combination with bleeding and/or suppuration on probing and a peri-implant Probing Depth (PD) of 5-8 mm.
- The implants have been in function for more than 2 years.
- Fixed prosthetic restoration of the implant.
Exclusion Criteria
- Pregnancy.
- Patient uses Chlorhexidine oral rinses/ mouthwashes on a regular basis.
- Allergic reaction to Chlorhexidine.
- Active Periodontitis which required definitive treatment.
- Presence of orthodontic appliances, or any removable appliances, that impinges on the tissues being assessed.
- Use of systemic antibiotic therapy and/or chronically use of non-steroidal anti-inflammatory drugs (NSAIDs).
- Uncontrolled diabetes, of any type.
Data sourced from ClinicalTrials.gov (NCT02080403). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.