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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Bleeding on Probing | Presence or absence of gingival bleeding within 30 seconds after probing | From baseline until the end of the study (6 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Probing pocket depth | Measure from the peri-implant mucosal margin to the base of the sulcus, applying a force of 0.2 N (20g) | From the baseline until the end of the study (6 months) |
| Plaque index |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AOU Città della Salute e della Scienza | Torino | Italy | 10126 | Italy |
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|
Presence or absence of plaque on implant surfaces
| From baseline until the end of the study (6 months) |
| Gingival recession | Measure from prosthetic crown to the peri-implant mucosal margin in millimeters | 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 | 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. | From the baseline until the end of the study (6 months) |