Trial Outcomes & Findings for The Efficacy and Safety of Chlorhexidine Gluconate Chip (PerioChip®) in Therapy of Peri-implantitis (NCT NCT02080403)
NCT ID: NCT02080403
Last Updated: 2022-09-13
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
290 participants
Primary outcome timeframe
Baseline to 6 months
Results posted on
2022-09-13
Participant Flow
Participant milestones
| Measure |
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.
|
Control
Mechanical Subgingival Debridement at Baseline and 3 months.
|
|---|---|---|
|
Overall Study
STARTED
|
146
|
144
|
|
Overall Study
COMPLETED
|
131
|
132
|
|
Overall Study
NOT COMPLETED
|
15
|
12
|
Reasons for withdrawal
| Measure |
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.
|
Control
Mechanical Subgingival Debridement at Baseline and 3 months.
|
|---|---|---|
|
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
The Efficacy and Safety of Chlorhexidine Gluconate Chip (PerioChip®) in Therapy of Peri-implantitis
Baseline characteristics by cohort
| Measure |
Treatment
n=146 Participants
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.
|
Control
n=144 Participants
Mechanical Subgingival Debridement at Baseline and 3 months.
|
Total
n=290 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.5 years
STANDARD_DEVIATION 11.2 • n=99 Participants
|
62.6 years
STANDARD_DEVIATION 11.6 • n=107 Participants
|
62.6 years
STANDARD_DEVIATION 11.4 • n=206 Participants
|
|
Sex: Female, Male
Female
|
91 Participants
n=99 Participants
|
81 Participants
n=107 Participants
|
172 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
55 Participants
n=99 Participants
|
63 Participants
n=107 Participants
|
118 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
14 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
131 Participants
n=99 Participants
|
134 Participants
n=107 Participants
|
265 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
8 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
117 Participants
n=99 Participants
|
127 Participants
n=107 Participants
|
244 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
95 participants
n=99 Participants
|
93 participants
n=107 Participants
|
188 participants
n=206 Participants
|
|
Region of Enrollment
United Kingdom
|
10 participants
n=99 Participants
|
11 participants
n=107 Participants
|
21 participants
n=206 Participants
|
|
Region of Enrollment
Israel
|
30 participants
n=99 Participants
|
28 participants
n=107 Participants
|
58 participants
n=206 Participants
|
|
Region of Enrollment
Germany
|
11 participants
n=99 Participants
|
12 participants
n=107 Participants
|
23 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline to 6 monthsPopulation: Intent to Treat
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.
Outcome measures
| Measure |
Treatment
n=180 Target implant
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.
|
Control
n=174 Target implant
Mechanical Subgingival Debridement at Baseline and 3 months.
|
|---|---|---|
|
Absolute Change in Mean Probing Pocket Depth for Selected Target Implants
|
-1.69 mm
Standard Deviation 1.18
|
-1.51 mm
Standard Deviation 1.16
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsPopulation: Intent to Treat
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.
Outcome measures
| Measure |
Treatment
n=141 Target implant
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.
|
Control
n=130 Target implant
Mechanical Subgingival Debridement at Baseline and 3 months.
|
|---|---|---|
|
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
|
-1.65 mm
Standard Deviation 1.18
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Intent to Treat
The proportion of the change in bleeding status (bleeding to no bleeding) for the selected target implant
Outcome measures
| Measure |
Treatment
n=180 Target implant
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.
|
Control
n=173 Target implant
Mechanical Subgingival Debridement at Baseline and 3 months.
|
|---|---|---|
|
Percentage of Selected Target Implants Bleeding on Probing (BOP)
|
90 Target implant
|
77 Target implant
|
SECONDARY outcome
Timeframe: Week 16The proportion of change in bleeding status (bleeding to no bleeding) for selected target implant
Outcome measures
| Measure |
Treatment
n=179 Target implant
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.
|
Control
n=165 Target implant
Mechanical Subgingival Debridement at Baseline and 3 months.
|
|---|---|---|
|
Precentage of Selected Target Implant BOP
|
76 Target implant
|
73 Target implant
|
Adverse Events
Treatment
Serious events: 4 serious events
Other events: 43 other events
Deaths: 0 deaths
Control
Serious events: 3 serious events
Other events: 19 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Treatment
n=146 participants at risk
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.
|
Control
n=144 participants at risk
Mechanical Subgingival Debridement at Baseline and 3 months.
|
|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.68%
1/146 • Number of events 1 • Screening through Week 24
All randomized patients who were treated with at least 1 study treatment or who underwent subgingival debridement.
|
0.00%
0/144 • Screening through Week 24
All randomized patients who were treated with at least 1 study treatment or who underwent subgingival debridement.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/146 • Screening through Week 24
All randomized patients who were treated with at least 1 study treatment or who underwent subgingival debridement.
|
0.69%
1/144 • Number of events 1 • Screening through Week 24
All randomized patients who were treated with at least 1 study treatment or who underwent subgingival debridement.
|
|
General disorders
Death
|
0.00%
0/146 • Screening through Week 24
All randomized patients who were treated with at least 1 study treatment or who underwent subgingival debridement.
|
0.69%
1/144 • Number of events 1 • Screening through Week 24
All randomized patients who were treated with at least 1 study treatment or who underwent subgingival debridement.
|
|
Infections and infestations
Diverticulitis
|
0.68%
1/146 • Number of events 1 • Screening through Week 24
All randomized patients who were treated with at least 1 study treatment or who underwent subgingival debridement.
|
0.00%
0/144 • Screening through Week 24
All randomized patients who were treated with at least 1 study treatment or who underwent subgingival debridement.
|
|
Musculoskeletal and connective tissue disorders
Forearm fracture
|
0.68%
1/146 • Number of events 1 • Screening through Week 24
All randomized patients who were treated with at least 1 study treatment or who underwent subgingival debridement.
|
0.00%
0/144 • Screening through Week 24
All randomized patients who were treated with at least 1 study treatment or who underwent subgingival debridement.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/146 • Screening through Week 24
All randomized patients who were treated with at least 1 study treatment or who underwent subgingival debridement.
|
0.69%
1/144 • Number of events 1 • Screening through Week 24
All randomized patients who were treated with at least 1 study treatment or who underwent subgingival debridement.
|
|
Nervous system disorders
Facial paralysis
|
0.68%
1/146 • Number of events 1 • Screening through Week 24
All randomized patients who were treated with at least 1 study treatment or who underwent subgingival debridement.
|
0.00%
0/144 • Screening through Week 24
All randomized patients who were treated with at least 1 study treatment or who underwent subgingival debridement.
|
Other adverse events
| Measure |
Treatment
n=146 participants at risk
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.
|
Control
n=144 participants at risk
Mechanical Subgingival Debridement at Baseline and 3 months.
|
|---|---|---|
|
General disorders
Implant site pain
|
8.2%
12/146 • Screening through Week 24
All randomized patients who were treated with at least 1 study treatment or who underwent subgingival debridement.
|
0.00%
0/144 • Screening through Week 24
All randomized patients who were treated with at least 1 study treatment or who underwent subgingival debridement.
|
|
Infections and infestations
Nasopharyngitis
|
3.4%
5/146 • Screening through Week 24
All randomized patients who were treated with at least 1 study treatment or who underwent subgingival debridement.
|
4.9%
7/144 • Screening through Week 24
All randomized patients who were treated with at least 1 study treatment or who underwent subgingival debridement.
|
|
Injury, poisoning and procedural complications
Post procedural discomfort
|
3.4%
5/146 • Screening through Week 24
All randomized patients who were treated with at least 1 study treatment or who underwent subgingival debridement.
|
0.69%
1/144 • Screening through Week 24
All randomized patients who were treated with at least 1 study treatment or who underwent subgingival debridement.
|
|
Surgical and medical procedures
Tooth repair
|
2.1%
3/146 • Screening through Week 24
All randomized patients who were treated with at least 1 study treatment or who underwent subgingival debridement.
|
1.4%
2/144 • Screening through Week 24
All randomized patients who were treated with at least 1 study treatment or who underwent subgingival debridement.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
2.1%
3/146 • Screening through Week 24
All randomized patients who were treated with at least 1 study treatment or who underwent subgingival debridement.
|
0.69%
1/144 • Screening through Week 24
All randomized patients who were treated with at least 1 study treatment or who underwent subgingival debridement.
|
|
Infections and infestations
Gingivitis
|
0.68%
1/146 • Screening through Week 24
All randomized patients who were treated with at least 1 study treatment or who underwent subgingival debridement.
|
2.1%
3/144 • Screening through Week 24
All randomized patients who were treated with at least 1 study treatment or who underwent subgingival debridement.
|
|
Gastrointestinal disorders
Toothache
|
3.4%
5/146 • Screening through Week 24
All randomized patients who were treated with at least 1 study treatment or who underwent subgingival debridement.
|
0.00%
0/144 • Screening through Week 24
All randomized patients who were treated with at least 1 study treatment or who underwent subgingival debridement.
|
|
Surgical and medical procedures
Artificial crown procedure
|
2.1%
3/146 • Screening through Week 24
All randomized patients who were treated with at least 1 study treatment or who underwent subgingival debridement.
|
0.00%
0/144 • Screening through Week 24
All randomized patients who were treated with at least 1 study treatment or who underwent subgingival debridement.
|
|
Gastrointestinal disorders
Gingival pain
|
2.1%
3/146 • Screening through Week 24
All randomized patients who were treated with at least 1 study treatment or who underwent subgingival debridement.
|
0.00%
0/144 • Screening through Week 24
All randomized patients who were treated with at least 1 study treatment or who underwent subgingival debridement.
|
|
Nervous system disorders
Headache
|
0.00%
0/146 • Screening through Week 24
All randomized patients who were treated with at least 1 study treatment or who underwent subgingival debridement.
|
2.8%
4/144 • Screening through Week 24
All randomized patients who were treated with at least 1 study treatment or who underwent subgingival debridement.
|
|
General disorders
Implant site swelling
|
2.1%
3/146 • Screening through Week 24
All randomized patients who were treated with at least 1 study treatment or who underwent subgingival debridement.
|
0.69%
1/144 • Screening through Week 24
All randomized patients who were treated with at least 1 study treatment or who underwent subgingival debridement.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place