Peri-implantitis
Conditions
Brief summary
The purpose of the study is to assess the efficacy and the safety of Chlorhexidine Gluconate chip (Periochip®) versus Placebo Chip in treatment of symptoms in patients with Peri-Implantitis.
Detailed description
This is a Phase 2a study assessing the safety and efficacy of Chlorhexidine Gluconate chip (Periochip®) versus Placebo Chip in treatment of symptoms in patients with Peri-Implantitis
Interventions
DRUGChlorhexidine 2.5 mg
DRUGPlacebo chip
Sponsors
Dexcel Pharma Technologies Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Signed and dated Informed Consent Form. 2. Good general health. 3. Male or female patients aged \>21 years old. 4. Availability for the 25 week duration of the study. 5. Peri-implantitis is characterized by the presence of at least 1 implant with periodontal pockets of 6-10 mm in depth (potential target implant) demonstrating Bleeding on Probing without involving the apex of the implant and confirmed radiographically. 6. Females of childbearing potential must be non-pregnant and non-lactating at entry and agree to use an adequate method of birth control during the study.
Exclusion criteria
1. Presence of oral local mechanical factors that could (in the opinion of the Investigator) influence the outcome of the study. 2. Presence of orthodontic appliances, or any removable appliances, that impinges on the tissues being assessed. 3. Presence of soft or hard tissue tumours of the oral cavity. 4. Horizontal inter implant distance ≤2 mm (if an adjacent implant exists). 5. Selection of the following dental implant types as target implant/s: hydroxylapatite (HA) and/or Titanium Plasma-sprayed (TPS). 6. History of allergy to Chlorhexidine. 7. Patients treated with systemic antibiotic therapy or periodontal/mechanical/local delivery therapy within 6 weeks prior to study entry and throughout the study duration. 8. Patients treated with non-steroidal anti-inflammatory drugs (NSAIDs) within 14 days prior to entry into the study and throughout the study duration (excluding treatment of acetylsalicylic acid ≤100 mg /day). 9. Patients taking Phenytoin, calcium channel blockers drugs (CCBs) and/or cyclosporine, which might influence the pattern of tissue response. 10. Presence of any of the following conditions: Type 1 diabetes, major recurrent aphtae stomatitis, abscesses and related oral pathologies. 11. The presence of any medical or psychiatric condition or any other condition that, in the opinion of the Investigator, could affect the successful participation of the patient in the study. 12. Patient participates in any other clinical study 30 days prior to the start of the study and throughout the study duration. 13. Patient uses Chlorhexidine oral rinses/ mouthwashes on a regular basis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Countries
Israel
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Chlorhexidine Chip (Periochip®) PerioChip®, consisting of 2.5 mg Chlorhexidine Gluconate
Chlorhexidine 2.5 mg | 30 |
| Placebo Chip Placebo chip | 30 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 2 |
| Overall Study | Protocol Violation | 0 | 2 |
Baseline characteristics
| Characteristic | Chlorhexidine Chip (Periochip®) | Total | Placebo Chip |
|---|---|---|---|
| Age, Continuous | 56.7 years STANDARD_DEVIATION 10.51 | 58.4 years STANDARD_DEVIATION 9.38 | 60.1 years STANDARD_DEVIATION 7.88 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 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 | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 30 Participants | 60 Participants | 30 Participants |
| Region of Enrollment Israel | 30 participants | 60 participants | 30 participants |
| Sex: Female, Male Female | 20 Participants | 35 Participants | 15 Participants |
| Sex: Female, Male Male | 10 Participants | 25 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 15 / 30 | 16 / 30 |
| serious Total, serious adverse events | 0 / 30 | 2 / 30 |
Outcome results
Primary
Change in Mean Probing Pocket Depth (PPD) for Selected Target Pocket
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
Time frame: Baseline to Week 24
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Chlorhexidine Chip (Periochip®) | Change in Mean Probing Pocket Depth (PPD) for Selected Target Pocket | -2.13 mm | Standard Deviation 1.399 |
| Placebo Chip | Change in Mean Probing Pocket Depth (PPD) for Selected Target Pocket | -1.79 mm | Standard Deviation 1.149 |
p-value: 0.162995% CI: [-1.19, 0.2]Mixed Models Analysis
Secondary
Bleeding on Probing (BOP)
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
Time frame: Baseline to Week 24
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Chlorhexidine Chip (Periochip®) | Bleeding on Probing (BOP) | 23 Target implant |
| Placebo Chip | Bleeding on Probing (BOP) | 16 Target implant |
Secondary
Clinical Attachment Levels (CAL)
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
Time frame: Baseline to Week 24
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Chlorhexidine Chip (Periochip®) | Clinical Attachment Levels (CAL) | -2.18 mm | Standard Deviation 1.394 |
| Placebo Chip | Clinical Attachment Levels (CAL) | -1.76 mm | Standard Deviation 1.257 |
p-value: 0.034795% CI: [-1.46, -0.06]Mixed Models Analysis