Peri-Implantitis
Conditions
Keywords
Peri-Implantitis, Periodontal Diseases, Chlorhexidine gluconate, PerioChip, Anti-Infective Agents, Mouth Diseases, Antiseptics
Brief 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.
Detailed description
This is a research study that uses the drug PerioChip® (active ingredient chlorhexidine gluconate) as an experimental treatment for periimplantitis. This condition is defined an inflammation affecting the tissues (gums and bone) around an already stable implant, resulting in loss of supporting jaw bone. It is caused by many factors but current research links the condition with the presence of bacteria in the mouth which are responsible for periodontitis (gum disease). If left untreated, this can lead to decreased bone support, weakening of the implant and potential lost of the implant. Nonsurgical treatment (deep cleaning with instruments to remove plaque) and rigorous diligent oral care at home are commonly used to treat both periimplantitis (gum disease around an implant) and periodontitis (gum disease around teeth). The medication PerioChip® is a small dental chip (its size is smaller than a match head, and it is completely flat). The chip contains chlorhexidine gluconate, an antimicrobial agent which is not an antibiotic. The chip is inserted into the gum sulcus that is present around the tooth or implant and biodegrades naturally within 7 to 10 days while releasing the medication. The purpose of this study is to determine the efficacy of PerioChip® in addition to a standard deep cleaning treatment regime, as compared to standard deep cleaning alone.in a large patient population, and to collect additional safety data about the treatment.
Interventions
DRUG2.5 mg Chlorhexidine gluconate chip
Subgingival debridement will be carried out for each one of the target implant. Upon completion of the debridement a PerioChip® will be inserted in each one of the target implant.
Sponsors
Dexcel Pharma Technologies Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
| Precentage of Selected Target Implant BOP | Week 16 | The proportion of change in bleeding status (bleeding to no bleeding) for selected target implant |
Countries
Germany, Israel, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment Treatment, 2.5 mg Chlorhexidine Gluconate chip (PerioChip®) inserted every two weeks starting at Baseline for the first 3 months, plus mechanical Subgingival Debridement at Baseline and 3 months.
2.5 mg Chlorhexidine gluconate chip: Subgingival debridement will be carried out for each one of the target implant. Upon completion of the debridement a PerioChip® will be inserted in each one of the target implant. | 146 |
| Control Mechanical Subgingival Debridement at Baseline and 3 months. | 144 |
| Total | 290 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 5 | 1 |
| Overall Study | Death | 0 | 2 |
| Overall Study | Lost to Follow-up | 2 | 0 |
| Overall Study | Pregnancy | 0 | 1 |
| Overall Study | Protocol Violation | 3 | 7 |
| Overall Study | Withdrawal by Subject | 5 | 1 |
Baseline characteristics
| Characteristic | Treatment | Total | Control |
|---|---|---|---|
| Age, Continuous | 62.5 years STANDARD_DEVIATION 11.2 | 62.6 years STANDARD_DEVIATION 11.4 | 62.6 years STANDARD_DEVIATION 11.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 14 Participants | 23 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 131 Participants | 265 Participants | 134 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 8 Participants | 13 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants | 13 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 11 Participants | 20 Participants | 9 Participants |
| Race (NIH/OMB) White | 117 Participants | 244 Participants | 127 Participants |
| Region of Enrollment Germany | 11 participants | 23 participants | 12 participants |
| Region of Enrollment Israel | 30 participants | 58 participants | 28 participants |
| Region of Enrollment United Kingdom | 10 participants | 21 participants | 11 participants |
| Region of Enrollment United States | 95 participants | 188 participants | 93 participants |
| Sex: Female, Male Female | 91 Participants | 172 Participants | 81 Participants |
| Sex: Female, Male Male | 55 Participants | 118 Participants | 63 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 146 | 2 / 144 |
| other Total, other adverse events | 43 / 146 | 19 / 144 |
| serious Total, serious adverse events | 4 / 146 | 3 / 144 |
Outcome results
Primary
Absolute Change in Mean Probing Pocket Depth for Selected Target Implants
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.
Time frame: Baseline to 6 months
Population: Intent to Treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Absolute Change in Mean Probing Pocket Depth for Selected Target Implants | -1.69 mm | Standard Deviation 1.18 |
| Control | Absolute Change in Mean Probing Pocket Depth for Selected Target Implants | -1.51 mm | Standard Deviation 1.16 |
p-value: 0.115995% CI: [-0.4, 0.04]Mixed Models Analysis
Secondary
Absolute Change in Mean Probing Pocket Depth of Selected Target Implants in Patients With Baseline Pocket Depth Measurement of 6-8 mm Inclusive
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.
Time frame: Baseline to 6 months
Population: Intent to Treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | 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 mm | Standard Deviation 1.25 |
| Control | Absolute Change in Mean Probing Pocket Depth of Selected Target Implants in Patients With Baseline Pocket Depth Measurement of 6-8 mm Inclusive | -1.65 mm | Standard Deviation 1.18 |
Secondary
Percentage of Selected Target Implants Bleeding on Probing (BOP)
The proportion of the change in bleeding status (bleeding to no bleeding) for the selected target implant
Time frame: 6 months
Population: Intent to Treat
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Treatment | Percentage of Selected Target Implants Bleeding on Probing (BOP) | 90 Target implant |
| Control | Percentage of Selected Target Implants Bleeding on Probing (BOP) | 77 Target implant |
Secondary
Precentage of Selected Target Implant BOP
The proportion of change in bleeding status (bleeding to no bleeding) for selected target implant
Time frame: Week 16
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Treatment | Precentage of Selected Target Implant BOP | 76 Target implant |
| Control | Precentage of Selected Target Implant BOP | 73 Target implant |