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Completed

NCT Number: NCT07047261

Efficacy of a Xanthan-based Chlorhexidine Gel in the Treatment of Peri-implant Mucositis

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.

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Key information

Conditions

Peri-implant Mucositis

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AOU Città della Salute e della Scienza

Torino, Italy, 10126

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Adjunctive use of Xanthan-Chlorexidine based gel

Procedure

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Probing pocket depth

    Time frame: From the baseline until the end of the study (6 months)

    Measure from the peri-implant mucosal margin to the base of the sulcus, applying a force of 0.2 N (20g)

  2. Plaque index

    Time frame: From baseline until the end of the study (6 months)

    Presence or absence of plaque on implant surfaces

  3. Gingival recession

    Time frame: From the baseline until the end of the study (6 months)

    Measure from prosthetic crown to the peri-implant mucosal margin in millimeters

  4. Keratinized gingiva

    Time frame: From the baseline until the end of the study (6 months)

    Measure from the peri-implant mucosal margin to oral mucosal margin in millimeters

  5. Clinical attachment level

    Time frame: From the baseline until the end of the study (6 months)

    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.

Sponsors and collaborators

Lead sponsor

University of Turin, Italy

Other

Registry information

Official study title

Efficacy of a Xanthan-based Chlorhexidine Gel in the Treatment of Peri-implant Mucositis: a Randomized Split-mouth Clinical Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 2, 2025
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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