Peri-ImplantitisNCT06083246
Clinical Efficacy of Hybenix vs Chlosite Gels in Peri-implantitis
A study testing Hybenix gel and Chlosite gel in people with Peri-Implantitis, run by University of Pavia at 1 site in Italy.
Trial summary
The present study is a randomized clinical trial (RCT). Patients responding to the inclusion criteria will be included. The following peri-implant indexes will be collected: Bleeding On Probing, Gingival Bleeding Index, Marginal Mucosal Conditions (swelling and erythema), Suppuration, Mucosal margin migration, PPD… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Peri-Implantitis
- What is being tested?
- Hybenix gel and Chlosite gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 10 Oct 2023to 10 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presence of at least one peri-implant site with perimplantitis diagnosed according to the latest Classification of Periodontal and Peri-Implant Diseases and Conditions [Berglundh et al., 2018]
Who cannot join
- Patient with cardiac pacemaker
- Patients suffering from psychological, neurological or psychiatric disorders
- Patients suffering from systemic, metabolic or autoimmune diseases
- Pregnant women
Trial locations and contacts
1 site in 1 country.
Italy1 site
Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia
Pavia, Lombardy, 27100
About this study
Official title: Efficacy of Hybenix and Chlosite Gels in Peri-implantitis Sites: a 9-month Randomized Clinical Trial.
The present study is a randomized clinical trial (RCT). Patients responding to the inclusion criteria will be included. The following peri-implant indexes will be collected: Bleeding On Probing, Gingival Bleeding Index, Marginal Mucosal Conditions (swelling and erythema), Suppuration, Mucosal margin migration, PPD Probing Pocket Depth, Plaque Index, Bleeding Score, radiographic bone loss.
After the peri-implant evaluation, patients will undergo supragingival and subgingival professional oral hygiene of both arches performed with ultrasonic instrumentation with PEEK inserts, manual instrumentation with teflon curettes and air polishing with glycine powder.
Read more
After that, the sample will be randomly divided into 2 groups based on thein-office assigned treatment:
- Chlosite® gel application in the peri-implant sulcus
- Hybenix® gel application for 30 s followed by rinsing of the peri-implant sulcus.
The study will last 9 months. Patients will be visited at: T0, after 1 month from T0 (T1), after 3 months (T2), after 6 months (T3) and after 9 months (T4).
In each time frame, indexes collection and nonsurgical debridement will be performed.
Read the detailed description
The present study is designed as a randomized clinical trial (RCT) to evaluate the clinical efficacy of two adjuvant gels in the treatment of perimplantitis.
Patients responding to the inclusion criteria will be included in the study. The following peri-implant indexes will be collected:
- BOP (Bleeding On Probing)
- GBI (Gingival Bleeding Index)
- Marginal Mucosal Conditions (swelling and erythema)
- Suppuration
- Mucosal margin migration
- PPD (Probing Pocket Depth)
- PI (Plaque Index)
- BS (Bleeding Score)
- Radiographic bone loss
After the peri-implant evaluation, patients will undergo supragingival and subgingival professional oral hygiene of both arches performed with ultrasonic instrumentation with PEEK inserts, manual instrumentation with teflon curettes and air polishing with glycine powder.
After that, the sample will be randomly divided into 2 groups based on thein-office assigned treatment:
- Chlosite® gel application in the peri-implant sulcus
- Hybenix® gel application for 30 s followed by rinsing of the peri-implant sulcus.
The study will last 9 months. Patients will be visited at: T0, after 1 month from T0 (T1), after 3 months (T2), after 6 months (T3) and after 9 months (T4).
In each time frame, indexes collection and nonsurgical debridement will be performed.
- Conditions
- Peri-Implantitis
- Being tested
- Hybenix gel, Chlosite gel
- Keywords
- Chlorhexidine, Hybenix gel, Domiciliary treatments
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hybenix gelOther
Clinical application of Hybenix gel after professional dental hygiene of peri-implant mucositis sites.
Chlosite gelOther
Clinical application of Chlosite gel after professional dental hygiene of peri-implant mucositis sites.
| Study group | Role | What they receive |
|---|---|---|
| Hybenix gel | Experimental | Clinical application of Hybenix gel. Receives: Other: Hybenix gel |
| Chlosite | Active comparator | Clinical application of Chlosite gel. Receives: Other: Chlosite gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in BOP - Bleeding On Probing
Dichotomous scoring (yes/no)
Measured: Baseline, 1, 3, 6 and 9 months.
Change in GBI - Gingival Bleeding Index (percentage)
Site-specific assessment of the presence or absence of gum bleeding after the insertion of the periodontal probe for the detection of PPD, detected on 6 sites.
The number of bleeding sites is divided per the total number of probed sites; the ratio is multiplied X 100.
Measured: Baseline, 1, 3, 6 and 9 months.
Change in marginal mucosa condition
Scoring criteria:
0: normal mucosa
- minimal inflammation with color change and minor edema
- moderate inflammation with redness, edema and glazing
- severe inflammation with redness, edema, ulceration and spontaneous bleeding without probing
Measured: Baseline, 1, 3, 6 and 9 months.
Change in suppuration
Dichotomous scoring (yes/no)
Measured: Baseline, 1, 3, 6 and 9 months.
Marginal mucosal migration
Dichotomous scoring (yes/no)
Measured: Baseline, 1, 3, 6 and 9 months.
Probing Depth
Evaluation (in mm) of the depth of the mucosal sulcus, through a millimeter periodontal probe; it is detected from the mucosal margin to the bottom of the peri-implant sulcus, evaluated at 6 sites.
Measured: Baseline, 1, 3, 6 and 9 months.
Change in BS - Bleeding Score
Scoring criteria:
0: no bleeding
- isolated visible spots
- blood forms a confluent red line on mucosal margin
- heavy or profuse bleeding
Measured: Baseline, 1, 3, 6 and 9 months.
Change in PI - Plaque Index (percentage)
Evaluation of the presence of plaque on the 4 surfaces of teeth on the total amount of dental surfaces.
Measured: Baseline, 1, 3, 6 and 9 months.
Change in Radiographic bone loss (percentage)
Quantitative evaluation of the bone loss evaluated on intraoral x-rays.
Measured: Baseline, 1, 3, 6 and 9 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2023
- Study start10 Oct 2023
- Primary completion20 Oct 2025
- Study completion10 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peri-ImplantitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Scribante, University of Pavia
- Investigators
- Andrea Scribante, DDS, PhD, MSc, Principal investigator, University of Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06083246
- Sponsor's protocol ID
- 2023-IMPLGEL
- Status last verified
- Jul 2026
- First submitted
- 8 Oct 2023
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be available upon motivated request to the Principal Investigator.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Hybenix and Chlosite Gels in Peri-implantitis Sites: a 9-month Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT06083246
- Acronym / sponsor ID
- 2023-IMPLGEL
- Conditions
- Peri-Implantitis
- Keywords
- Chlorhexidine, Hybenix gel, Domiciliary treatments
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of PaviaUniversity, hospital or other
- Study start
- 10 Oct 2023 (actual)
- Primary completion
- 20 Oct 2025 (actual)
- Study completion
- 10 Nov 2025 (actual)
- First posted
- 13 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The present study is a randomized clinical trial (RCT). Patients responding to the inclusion criteria will be included. The following peri-implant indexes will be collected: Bleeding On Probing, Gingival Bleeding Index, Marginal Mucosal Conditions (swelling and erythema), Suppuration, Mucosal margin migration, PPD Probing Pocket Depth, Plaque Index, Bleeding Score, radiographic bone loss.
After the peri-implant evaluation, patients will undergo supragingival and subgingival professional oral hygiene of both arches performed with ultrasonic instrumentation with PEEK inserts, manual instrumentation with teflon curettes and air polishing with glycine powder.
After that, the sample will be randomly divided into 2 groups based on thein-office assigned treatment:
- Chlosite® gel application in the peri-implant sulcus
- Hybenix® gel application for 30 s followed by rinsing of the peri-implant sulcus.
The study will last 9 months. Patients will be visited at: T0, after 1 month from T0 (T1), after 3 months (T2), after 6 months (T3) and after 9 months (T4).
In each time frame, indexes collection and nonsurgical debridement will be performed.
Detailed description
The present study is designed as a randomized clinical trial (RCT) to evaluate the clinical efficacy of two adjuvant gels in the treatment of perimplantitis.
Patients responding to the inclusion criteria will be included in the study. The following peri-implant indexes will be collected:
- BOP (Bleeding On Probing)
- GBI (Gingival Bleeding Index)
- Marginal Mucosal Conditions (swelling and erythema)
- Suppuration
- Mucosal margin migration
- PPD (Probing Pocket Depth)
- PI (Plaque Index)
- BS (Bleeding Score)
- Radiographic bone loss
After the peri-implant evaluation, patients will undergo supragingival and subgingival professional oral hygiene of both arches performed with ultrasonic instrumentation with PEEK inserts, manual instrumentation with teflon curettes and air polishing with glycine powder.
After that, the sample will be randomly divided into 2 groups based on thein-office assigned treatment:
- Chlosite® gel application in the peri-implant sulcus
- Hybenix® gel application for 30 s followed by rinsing of the peri-implant sulcus.
The study will last 9 months. Patients will be visited at: T0, after 1 month from T0 (T1), after 3 months (T2), after 6 months (T3) and after 9 months (T4).
In each time frame, indexes collection and nonsurgical debridement will be performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hybenix gel | Experimental | Other: Hybenix gelClinical application of Hybenix gel. |
| Chlosite | Active comparator | Other: Chlosite gelClinical application of Chlosite gel. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Presence of at least one peri-implant site with perimplantitis diagnosed according to the latest Classification of Periodontal and Peri-Implant Diseases and Conditions [Berglundh et al., 2018]
Key exclusion criteria (4 listed)
- Patient with cardiac pacemaker
- Patients suffering from psychological, neurological or psychiatric disorders
- Patients suffering from systemic, metabolic or autoimmune diseases
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hybenix gelClinical application of Hybenix gel after professional dental hygiene of peri-implant mucositis sites. | Other | Hybenix gel |
| Chlosite gelClinical application of Chlosite gel after professional dental hygiene of peri-implant mucositis sites. | Other | Chlosite |
Primary outcome
Change in BOP - Bleeding On Probing
Time frame: Baseline, 1, 3, 6 and 9 months.
Dichotomous scoring (yes/no)
Change in GBI - Gingival Bleeding Index (percentage)
Time frame: Baseline, 1, 3, 6 and 9 months.
Site-specific assessment of the presence or absence of gum bleeding after the insertion of the periodontal probe for the detection of PPD, detected on 6 sites. The number of bleeding sites is divided per the total number of probed sites; the ratio is multiplied X 100.
Change in marginal mucosa condition
Time frame: Baseline, 1, 3, 6 and 9 months.
Scoring criteria: 0: normal mucosa 1. minimal inflammation with color change and minor edema 2. moderate inflammation with redness, edema and glazing 3. severe inflammation with redness, edema, ulceration and spontaneous bleeding without probing
Change in suppuration
Time frame: Baseline, 1, 3, 6 and 9 months.
Dichotomous scoring (yes/no)
Marginal mucosal migration
Time frame: Baseline, 1, 3, 6 and 9 months.
Dichotomous scoring (yes/no)
Probing Depth
Time frame: Baseline, 1, 3, 6 and 9 months.
Evaluation (in mm) of the depth of the mucosal sulcus, through a millimeter periodontal probe; it is detected from the mucosal margin to the bottom of the peri-implant sulcus, evaluated at 6 sites.
Change in BS - Bleeding Score
Time frame: Baseline, 1, 3, 6 and 9 months.
Scoring criteria: 0: no bleeding 1. isolated visible spots 2. blood forms a confluent red line on mucosal margin 3. heavy or profuse bleeding
Change in PI - Plaque Index (percentage)
Time frame: Baseline, 1, 3, 6 and 9 months.
Evaluation of the presence of plaque on the 4 surfaces of teeth on the total amount of dental surfaces.
Change in Radiographic bone loss (percentage)
Time frame: Baseline, 1, 3, 6 and 9 months.
Quantitative evaluation of the bone loss evaluated on intraoral x-rays.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Individual participant dataSharing planned: No. Data will be available upon motivated request to the Principal Investigator.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Scribante, DDS, PhD, MSc principal investigator
University of Pavia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hybenix gel and Chlosite gel in people with Peri-Implantitis, run by University of Pavia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in BOP - Bleeding On Probing (time frame: Baseline, 1, 3, 6 and 9 months.). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.