Peri-implant MucositisNCT07047261
Efficacy of a Xanthan-based Chlorhexidine Gel in the Treatment of Peri-implant Mucositis
A study testing Adjunctive use of Xanthan-Chlorexidine based gel in people with Peri-implant Mucositis, run by University of Turin, Italy at 1 site in Italy.
Trial summary
The peri-implant mucositis is an inflammatory and reversible lesion that surrounds the peri-implant mucosa without loss of supporting bone, clinically characterized by bleeding on gentle probing. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Peri-implant Mucositis
- What is being tested?
- Adjunctive use of Xanthan-Chlorexidine based gel
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 1 siteItaly
- Study dates
- 14 Feb 2025to 1 Sep 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- presence of two or more peri-implant mucositis sites (e.g. presence of bleeding and/or suppuration on probing with no bone loss evident on radiographs);
- implant-supported fixed restorations inserted at least 6 months before patient enrollment
Who cannot join
- radiation therapy in the head and neck therapy or long-term corticosteroid treatments;
- use of systemic antibiotics for more than 6 months;
- diagnosis of not plaque-associated inflammatory diseases (e.g., Oral Lichen Planus);
- pregnant or breastfeeding mother;
- untreated peri-implantitis;
- oral rehabilitation with full-arch prostheses;
- allergy to chlorhexidine and/or other components contained in the gel.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of a Xanthan-based Chlorhexidine Gel in the Treatment of Peri-implant Mucositis: a Randomized Split-mouth Clinical Trial
The peri-implant mucositis is an inflammatory and reversible lesion that surrounds the peri-implant mucosa without loss of supporting bone, clinically characterized by bleeding on gentle probing. It has been estimated that it affects approximately 21% to 88% of individuals and 9% to 51% of implant sites, with prevalences of 47% and 29%, respectively.
Experimental clinical researches show that peri-implant mucositis can be reversed if proper biofilm management is maintained. Prevention and regression of inflammation around the implant can be achieved through proper oral hygiene and an effective supportive care protocol, which may include regular clinical check-ups, radiographic assessments, oral hygiene instructions and professional mechanical plaque removal (PMPR).
Read more
Therefore, adjunctive measures such as self-administration of oral rinse antiseptics (i.e. chlorhexidine) may be considered. For examples, the use of a chlorhexidine-based gel in combination with xanthan (XanCHX), in addition to PMPR has demonstrated clinical improvements in the treatment of periodontitis.
The aim of the present study was to investigate the potential benefits of XanCHX gel in adjunction to PMPR in patients affected by peri-implant mucositis, promoting a complete healing of the affected tissues.
- Conditions
- Peri-implant Mucositis
- Being tested
- Adjunctive use of Xanthan-Chlorexidine based gel
- Keywords
- Peri-implant mucositis, adjunctive treatment, professional mechanical plaque removal, Xanthan-chlorhexidine based gel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adjunctive use of Xanthan-Chlorexidine based gelProcedure or surgery
The chlorhexidine and xanthan-based gel contains 0.5% chlorhexidine digluconate, 1% chlorhexidine dihydrochloride, and 0.5% xanthan gel. Xanthan is a polymer that creates a three-dimensional, pseudo-plastic network with water, forming a stable gel that allows a slow and prolonged release of chlorhexidine, allowing effectiveness for about 30 days. Chlorhexidine digluconate is released immediately upon application, whereas Chlorhexidine dihydrochloride is gradually delivered the following days, providing bacteriostatic and bactericidal effects for up to two weeks, helping the prevention of recolonization of treated site.
The clinician cleaned and dried the implant site using compressed air and applied the XanCHX gel on the implant sites assigned to the test group, positioning the blunt needle at the bottom of the pocket and gently extruding the product while moving it out of the site. Finally, the patient was instructed not to drink or rinse for the following hour.
| Study group | Role | What they receive |
|---|---|---|
| Professional mechanical plaque removal with xanthan-chlorhexidine based gel | Experimental | At baseline, after recording clinical parameters, patients received oral hygiene instruction and underwent periodontal debridement alternating ultrasonic with manual instruments, followed by the use of air-abrasive devices with 25-micron glycine powder and a supragingival tip Subsequently, the clinician cleaned and dried the site using compressed air and applied the XanCHX gel on the implant sites assigned to the test group, positioning the blunt needle at the bottom of the pocket and gently extruding the product while moving it out of the site. Finally, the patient was instructed not to drink or rinse for the following hour. At each time-step, clinical assessments were recorded after the reinforcement in oral hygiene instruction and professional implant hygiene using rubber cup and polishing paste. Receives: Procedure: Adjunctive use of Xanthan-Chlorexidine based gel |
| Professional mechanical plaque removal alone | No intervention | At baseline, after recording clinical parameters, patients received oral hygiene instruction and underwent periodontal debridement alternating ultrasonic with manual instruments, followed by the use of air-abrasive devices with 25-micron glycine powder and a supragingival tip. At each time-step, clinical assessments were recorded after the reinforcement in oral hygiene instruction and professional implant hygiene using rubber cup and polishing paste. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding on Probing
Presence or absence of gingival bleeding within 30 seconds after probing
Measured: From baseline until the end of the study (6 months)
Secondary outcomes (5)
Probing pocket depth
Measure from the peri-implant mucosal margin to the base of the sulcus, applying a force of 0.2 N (20g)
Measured: From the baseline until the end of the study (6 months)
Plaque index
Presence or absence of plaque on implant surfaces
Measured: From baseline until the end of the study (6 months)
Gingival recession
Measure from prosthetic crown to the peri-implant mucosal margin in millimeters
Measured: From the baseline until the end of the study (6 months)
Keratinized gingiva
Measure from the peri-implant mucosal margin to oral mucosal margin in millimeters
Measured: From the baseline until the end of the study (6 months)
Clinical attachment level
Measure, in millimeters, of the amount of gum tissue and bone attached to the root of the tooth. Specifically, it is the sum of the measurement of gingival recession and the probing depth.
Measured: From the baseline until the end of the study (6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2025
- Study start14 Feb 2025
- Primary completion30 Aug 2025
- Study completion1 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peri-implant MucositisStudies 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
- None (open label)
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jacopo Lanzetti, University of Turin, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07047261
- Sponsor's protocol ID
- 00453/2024
- Status last verified
- Jun 2025
- First submitted
- 17 Jun 2025
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Xanthan-based Chlorhexidine Gel in the Treatment of Peri-implant Mucositis: a Randomized Split-mouth Clinical Trial
- ClinicalTrials.gov ID
- NCT07047261
- Acronym / sponsor ID
- 00453/2024
- Conditions
- Peri-implant Mucositis
- Keywords
- Peri-implant mucositis, adjunctive treatment, professional mechanical plaque removal, Xanthan-chlorhexidine based gel
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Study start
- 14 Feb 2025 (actual)
- Primary completion
- 30 Aug 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 2 Jul 2025 (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 peri-implant mucositis is an inflammatory and reversible lesion that surrounds the peri-implant mucosa without loss of supporting bone, clinically characterized by bleeding on gentle probing. It has been estimated that it affects approximately 21% to 88% of individuals and 9% to 51% of implant sites, with prevalences of 47% and 29%, respectively.
Experimental clinical researches show that peri-implant mucositis can be reversed if proper biofilm management is maintained. Prevention and regression of inflammation around the implant can be achieved through proper oral hygiene and an effective supportive care protocol, which may include regular clinical check-ups, radiographic assessments, oral hygiene instructions and professional mechanical plaque removal (PMPR).
Therefore, adjunctive measures such as self-administration of oral rinse antiseptics (i.e. chlorhexidine) may be considered. For examples, the use of a chlorhexidine-based gel in combination with xanthan (XanCHX), in addition to PMPR has demonstrated clinical improvements in the treatment of periodontitis.
The aim of the present study was to investigate the potential benefits of XanCHX gel in adjunction to PMPR in patients affected by peri-implant mucositis, promoting a complete healing of the affected tissues.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Professional mechanical plaque removal with xanthan-chlorhexidine based gel | Experimental | Procedure: Adjunctive use of Xanthan-Chlorexidine based gelAt baseline, after recording clinical parameters, patients received oral hygiene instruction and underwent periodontal debridement alternating ultrasonic with manual instruments, followed by the use of air-abrasive devices with 25-micron glycine powder and a supragingival tip Subsequently, the clinician cleaned and dried the site using compressed air and applied the XanCHX gel on the implant sites assigned to the test group, positioning the blunt needle at the bottom of the pocket and gently extruding the product while moving it out of the site. Finally, the patient was instructed not to drink or rinse for the following hour. At each time-step, clinical assessments were recorded after the reinforcement in oral hygiene instruction and professional implant hygiene using rubber cup and polishing paste. |
| Professional mechanical plaque removal alone | No intervention | –At baseline, after recording clinical parameters, patients received oral hygiene instruction and underwent periodontal debridement alternating ultrasonic with manual instruments, followed by the use of air-abrasive devices with 25-micron glycine powder and a supragingival tip. At each time-step, clinical assessments were recorded after the reinforcement in oral hygiene instruction and professional implant hygiene using rubber cup and polishing paste. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- presence of two or more peri-implant mucositis sites (e.g. presence of bleeding and/or suppuration on probing with no bone loss evident on radiographs);
- implant-supported fixed restorations inserted at least 6 months before patient enrollment
Key exclusion criteria (7 listed)
- radiation therapy in the head and neck therapy or long-term corticosteroid treatments;
- use of systemic antibiotics for more than 6 months;
- diagnosis of not plaque-associated inflammatory diseases (e.g., Oral Lichen Planus);
- pregnant or breastfeeding mother;
- untreated peri-implantitis;
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 |
|---|---|---|
| Adjunctive use of Xanthan-Chlorexidine based gelThe chlorhexidine and xanthan-based gel contains 0.5% chlorhexidine digluconate, 1% chlorhexidine dihydrochloride, and 0.5% xanthan gel. Xanthan is a polymer that creates a three-dimensional, pseudo-plastic network with water, forming a stable gel that allows a slow and prolonged release of chlorhexidine, allowing effectiveness for about 30 days. Chlorhexidine digluconate is released immediately upon application, whereas Chlorhexidine dihydrochloride is gradually delivered the following days, providing bacteriostatic and bactericidal effects for up to two weeks, helping the prevention of recolonization of treated site. The clinician cleaned and dried the implant site using compressed air and applied the XanCHX gel on the implant sites assigned to the test group, positioning the blunt needle at the bottom of the pocket and gently extruding the product while moving it out of the site. Finally, the patient was instructed not to drink or rinse for the following hour. | Procedure or surgery | Professional mechanical plaque removal with xanthan-chlorhexidine based gel |
Primary outcome
Bleeding on Probing
Time frame: From baseline until the end of the study (6 months)
Presence or absence of gingival bleeding within 30 seconds after probing
5 secondary outcomes
Probing pocket depth
Time frame: From the baseline until the end of the study (6 months)
Plaque index
Time frame: From baseline until the end of the study (6 months)
Gingival recession
Time frame: From the baseline until the end of the study (6 months)
Keratinized gingiva
Time frame: From the baseline until the end of the study (6 months)
Clinical attachment level
Time frame: From the baseline until the end of the study (6 months)
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 29 Apr 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adjunctive use of Xanthan-Chlorexidine based gel in people with Peri-implant Mucositis, run by University of Turin, Italy 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 2 inclusion and 7 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 29 Apr 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?
Bleeding on Probing (time frame: From baseline until the end of the study (6 months)). 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 29 Apr 2026.