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

University of Turin

Status: Enrolling

Conditions: Peri-implant Mucositis

Treatments: Procedure: Adjunctive use of Xanthan-Chlorexidine based gel

Study type: Interventional

Funder types: Other

Identifiers

NCT07047261

00453/2024

Details and patient eligibility

About

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.

Enrollment: 182 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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182 participants in 2 patient groups

Professional mechanical plaque removal with xanthan-chlorhexidine based gel

Experimental group

Description:

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.

Treatment:

Procedure: Adjunctive use of Xanthan-Chlorexidine based gel

Professional mechanical plaque removal alone

No Intervention group

Description:

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.