Trial Outcomes & Findings for The Efficacy and Safety of Chlorhexidine Gluconate Chip (Periochip®) in Therapy of Symptoms in Patients With Peri-implantitis (NCT NCT01079663)

Last Updated: 2021-06-15

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

60 participants

Primary outcome timeframe

Baseline to Week 24

Results posted on

2021-06-15

Participant Flow

Participant milestones

Participant milestones
Measure	Chlorhexidine Chip (Periochip®) PerioChip®, consisting of 2.5 mg Chlorhexidine Gluconate Chlorhexidine 2.5 mg	Placebo Chip Placebo chip
Overall Study STARTED	30	30
Overall Study COMPLETED	30	26
Overall Study NOT COMPLETED	0	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Chlorhexidine Chip (Periochip®) PerioChip®, consisting of 2.5 mg Chlorhexidine Gluconate Chlorhexidine 2.5 mg	Placebo Chip Placebo chip
Overall Study Adverse Event	0	2
Overall Study Protocol Violation	0	2

Baseline Characteristics

The Efficacy and Safety of Chlorhexidine Gluconate Chip (Periochip®) in Therapy of Symptoms in Patients With Peri-implantitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Chlorhexidine Chip (Periochip®) n=30 Participants PerioChip®, consisting of 2.5 mg Chlorhexidine Gluconate Chlorhexidine 2.5 mg	Placebo Chip n=30 Participants Placebo chip	Total n=60 Participants Total of all reporting groups
Age, Continuous	56.7 years STANDARD_DEVIATION 10.51 • n=99 Participants	60.1 years STANDARD_DEVIATION 7.88 • n=107 Participants	58.4 years STANDARD_DEVIATION 9.38 • n=206 Participants
Sex: Female, Male Female	20 Participants n=99 Participants	15 Participants n=107 Participants	35 Participants n=206 Participants
Sex: Female, Male Male	10 Participants n=99 Participants	15 Participants n=107 Participants	25 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	0 Participants n=99 Participants	0 Participants n=107 Participants	0 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	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) White	30 Participants n=99 Participants	30 Participants n=107 Participants	60 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	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Region of Enrollment Israel	30 participants n=99 Participants	30 participants n=107 Participants	60 participants n=206 Participants

PRIMARY outcome

Timeframe: Baseline to Week 24

Outcome measures

Outcome measures
Measure	Chlorhexidine Chip (Periochip®) n=40 Target implant PerioChip®, consisting of 2.5 mg Chlorhexidine Gluconate Chlorhexidine 2.5 mg	Placebo Chip n=37 Target implant Placebo chip
Change in Mean Probing Pocket Depth (PPD) for Selected Target Pocket	-2.13 mm Standard Deviation 1.399	-1.79 mm Standard Deviation 1.149

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Chlorhexidine Chip (Periochip®) n=40 Target implant PerioChip®, consisting of 2.5 mg Chlorhexidine Gluconate Chlorhexidine 2.5 mg	Placebo Chip n=37 Target implant Placebo chip
Clinical Attachment Levels (CAL)	-2.18 mm Standard Deviation 1.394	-1.76 mm Standard Deviation 1.257

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Chlorhexidine Chip (Periochip®) n=40 Target implant PerioChip®, consisting of 2.5 mg Chlorhexidine Gluconate Chlorhexidine 2.5 mg	Placebo Chip n=37 Target implant Placebo chip
Bleeding on Probing (BOP)	23 Target implant	16 Target implant

Adverse Events

Chlorhexidine Chip (Periochip®)

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Placebo Chip

Serious events: 2 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Chlorhexidine Chip (Periochip®) n=30 participants at risk PerioChip®, consisting of 2.5 mg Chlorhexidine Gluconate Chlorhexidine 2.5 mg	Placebo Chip n=30 participants at risk Placebo chip
Injury, poisoning and procedural complications Head injury	0.00% 0/30 • Baseline through Week 24 All patients who receive study drug and have at least one follow-up assessment after beginning treatment	3.3% 1/30 • Baseline through Week 24 All patients who receive study drug and have at least one follow-up assessment after beginning treatment
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/30 • Baseline through Week 24 All patients who receive study drug and have at least one follow-up assessment after beginning treatment	3.3% 1/30 • Baseline through Week 24 All patients who receive study drug and have at least one follow-up assessment after beginning treatment

Other adverse events

Other adverse events
Measure	Chlorhexidine Chip (Periochip®) n=30 participants at risk PerioChip®, consisting of 2.5 mg Chlorhexidine Gluconate Chlorhexidine 2.5 mg	Placebo Chip n=30 participants at risk Placebo chip
Gastrointestinal disorders Aphthous ulcer	3.3% 1/30 • Baseline through Week 24 All patients who receive study drug and have at least one follow-up assessment after beginning treatment	6.7% 2/30 • Baseline through Week 24 All patients who receive study drug and have at least one follow-up assessment after beginning treatment
Gastrointestinal disorders Gingival swelling	10.0% 3/30 • Baseline through Week 24 All patients who receive study drug and have at least one follow-up assessment after beginning treatment	0.00% 0/30 • Baseline through Week 24 All patients who receive study drug and have at least one follow-up assessment after beginning treatment
Gastrointestinal disorders Periodontal disease	10.0% 3/30 • Baseline through Week 24 All patients who receive study drug and have at least one follow-up assessment after beginning treatment	0.00% 0/30 • Baseline through Week 24 All patients who receive study drug and have at least one follow-up assessment after beginning treatment
Gastrointestinal disorders Periodontal inflammation	0.00% 0/30 • Baseline through Week 24 All patients who receive study drug and have at least one follow-up assessment after beginning treatment	10.0% 3/30 • Baseline through Week 24 All patients who receive study drug and have at least one follow-up assessment after beginning treatment
Gastrointestinal disorders Toothache	0.00% 0/30 • Baseline through Week 24 All patients who receive study drug and have at least one follow-up assessment after beginning treatment	6.7% 2/30 • Baseline through Week 24 All patients who receive study drug and have at least one follow-up assessment after beginning treatment
General disorders Implant site pain	6.7% 2/30 • Baseline through Week 24 All patients who receive study drug and have at least one follow-up assessment after beginning treatment	13.3% 4/30 • Baseline through Week 24 All patients who receive study drug and have at least one follow-up assessment after beginning treatment
General disorders Feeling cold	10.0% 3/30 • Baseline through Week 24 All patients who receive study drug and have at least one follow-up assessment after beginning treatment	3.3% 1/30 • Baseline through Week 24 All patients who receive study drug and have at least one follow-up assessment after beginning treatment
Infections and infestations Nasopharyngitis	6.7% 2/30 • Baseline through Week 24 All patients who receive study drug and have at least one follow-up assessment after beginning treatment	0.00% 0/30 • Baseline through Week 24 All patients who receive study drug and have at least one follow-up assessment after beginning treatment
Injury, poisoning and procedural complications Dental restoration failure	0.00% 0/30 • Baseline through Week 24 All patients who receive study drug and have at least one follow-up assessment after beginning treatment	6.7% 2/30 • Baseline through Week 24 All patients who receive study drug and have at least one follow-up assessment after beginning treatment
Surgical and medical procedures Tooth extraction	3.3% 1/30 • Baseline through Week 24 All patients who receive study drug and have at least one follow-up assessment after beginning treatment	6.7% 2/30 • Baseline through Week 24 All patients who receive study drug and have at least one follow-up assessment after beginning treatment

Additional Information

Clinical Trial Department Manager

Dexcel Pharma

Phone: 972-4-6364000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place