A Phase 3 interventional study of 2.5 mg Chlorhexidine gluconate chip in Peri-Implantitis, sponsored by Dexcel Pharma Technologies Ltd.. Completed at 10 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-09-13.
Sponsored by Dexcel Pharma Technologies Ltd. · Phase 3, Interventional, and Treatment
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.
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.
313 studies on the registry are indexed under Peri-Implantitis; 85 are open to participants now.
This study's enrollment of 290 is above the median of 40 across 191 interventional studies indexed under Peri-Implantitis.
Browse Peri-Implantitis studies →Dexcel Pharma Technologies Ltd. is the lead sponsor of 5 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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.
Drug: 2.5 mg Chlorhexidine gluconate chip
Mechanical Subgingival Debridement at Baseline and 3 months.
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.
Also known as: PerioChip®
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
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
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
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
| Milestone | Treatment | Control |
|---|---|---|
| Started | 146 | 144 |
| Completed | 131 | 132 |
| Not completed | 15 | 12 |
| Withdrew: Adverse event | 5 | 1 |
| Withdrew: Death | 0 | 2 |
| Withdrew: Lost to follow-up | 2 | 0 |
| Withdrew: Pregnancy | 0 | 1 |
| Withdrew: Protocol violation | 3 | 7 |
| Withdrew: Withdrawal by subject | 5 | 1 |
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.
| mm | Treatment | Control |
|---|---|---|
| Absolute Change in Mean Probing Pocket Depth for Selected Target Implants | -1.69 ± 1.18 | -1.51 ± 1.16 |
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.
| mm | Treatment | Control |
|---|---|---|
| Absolute Change in Mean Probing Pocket Depth of Selected Target Implants in Patients With Baseline Pocket Depth Measurement of 6-8 mm Inclusive | -1.77 ± 1.25 | -1.65 ± 1.18 |
The proportion of the change in bleeding status (bleeding to no bleeding) for the selected target implant
| Target implant | Treatment | Control |
|---|---|---|
| Percentage of Selected Target Implants Bleeding on Probing (BOP) | 90 | 77 |
The proportion of change in bleeding status (bleeding to no bleeding) for selected target implant
| Target implant | Treatment | Control |
|---|---|---|
| Precentage of Selected Target Implant BOP | 76 | 73 |
Collected over Screening through Week 24. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment | 0/146 (0%) | 4/146 (2.7%) | 43/146 (29.5%) |
| Control | 2/144 (1.4%) | 3/144 (2.1%) | 19/144 (13.2%) |
| Event | Treatment | Control |
|---|---|---|
| Ventricular tachycardiaCardiac disorders | 0/146 | 1/144 |
| DeathGeneral disorders | 0/146 | 1/144 |
| Colon cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/146 | 1/144 |
| Acute myocardial infarctionCardiac disorders | 1/146 | 0/144 |
| DiverticulitisInfections and infestations | 1/146 | 0/144 |
| Forearm fractureMusculoskeletal and connective tissue disorders | 1/146 | 0/144 |
| Facial paralysisNervous system disorders | 1/146 | 0/144 |
| Event | Treatment | Control |
|---|---|---|
| Implant site painGeneral disorders | 12/146 | 0/144 |
| NasopharyngitisInfections and infestations | 5/146 | 7/144 |
| Post procedural discomfortInjury, poisoning and procedural complications | 5/146 | 1/144 |
| ToothacheGastrointestinal disorders | 5/146 | 0/144 |
| HeadacheNervous system disorders | 0/146 | 4/144 |
| GingivitisInfections and infestations | 1/146 | 3/144 |
| Tooth repairSurgical and medical procedures | 3/146 | 2/144 |
| Aphthous ulcerGastrointestinal disorders | 3/146 | 1/144 |
| Artificial crown procedureSurgical and medical procedures | 3/146 | 0/144 |
| Gingival painGastrointestinal disorders | 3/146 | 0/144 |
| Age, Continuous(years) | Treatment | Control | Total |
|---|---|---|---|
| Mean | 62.5 ± 11.2 | 62.6 ± 11.6 | 62.6 ± 11.4 |
| Sex: Female, Male(Participants) | Treatment | Control | Total |
|---|---|---|---|
| Female | 91 | 81 | 172 |
| Male | 55 | 63 | 118 |
| Ethnicity (NIH/OMB)(Participants) | Treatment | Control | Total |
|---|---|---|---|
| Hispanic or Latino | 14 | 9 | 23 |
| Not Hispanic or Latino | 131 | 134 | 265 |
| Unknown or Not Reported | 1 | 1 | 2 |
| Race (NIH/OMB)(Participants) | Treatment | Control | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 8 | 5 | 13 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 10 | 3 | 13 |
| White | 117 | 127 | 244 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 11 | 9 | 20 |
| Region of Enrollment(participants) | Treatment | Control | Total |
|---|---|---|---|
| United States | 95 | 93 | 188 |
| United Kingdom | 10 | 11 | 21 |
| Israel | 30 | 28 | 58 |
| Germany | 11 | 12 | 23 |
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Studies of the drug tested here: Chlorhexidine gluconate
Dexcel Pharma Technologies Ltd.