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Recruiting NCT07047261

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

Trial Parameters

Condition Peri-implant Mucositis
Sponsor University of Turin, Italy
Study Type INTERVENTIONAL
Phase N/A
Enrollment 182
Sex ALL
Min Age 18 Years
Max Age 90 Years
Start Date 2025-02-14
Completion 2025-08-30
Interventions
Adjunctive use of Xanthan-Chlorexidine based gel

Brief 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. 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.

Eligibility Criteria

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.

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