University-Hospital
Ferrara, Italy
NCT Number: NCT03465670
Backround: No data on the adjunctive effects of hyaluronic acid (HA) in a post-surgery, chlorhexidine (CHX) - based plaque control regimen are available. Also, contrasting evidence is available regarding the efficacy of CHX-based formulations containing anti-discoloration system (ADS). The aim of the present study was to evaluate the post-surgery gingival healing as well as plaque, gingival inflammation, and staining levels following the use of a 0.2% chlorhexidine (CHX) solution with or without anti-discoloration system (ADS) and 0.2% hyaluronic acid (HA).
Methods: Patients undergoing flap surgery at sites with an intact or reduced but healthy periodontium participated in a parallel-arm RCT. After surgery, patients used the assigned mouthrinse (CHX+HA+ADS or CHX) for 21 days. At day 7 and 21, the Gingival Healing Index (GHI) was used to assess the quality of flap closure at the interdental papilla. Plaque index (PlI), Gingival Index (GI), Angulated bleeding score (AngBS), tooth and tongue staining were also assessed.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Ferrara, Italy
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Patients were included in the study if positive for each of the following patient related criteria:
Patients were included in the study if positive for each of the following surgery-related criteria (verified as part of their overall treatment plan):
Exclusion criteria
Patients were excluded from the study (at either recruitment or during the experimental phase) if positive for one or more of the following patient-related criteria:
Patients were excluded from the study if the experimental teeth were positive for one or more of the following criteria:
Patients received a 21-day supply of 0.2% chlorhexidine (CHX) according to the randomization list, and were instructed to use 10 ml of the assigned mouthrinse for 1 minute, t.i.d. for 21 days. After rinsing, patients were asked to avoid washing their mouth or drinking for 30 minutes. Patients were asked to return the mouthrinse bottles (either empty of filled) at the end of the experimental period (day 21), in order to assess the level of patient compliance with the assigned CHX regimen.
Patients received a 21-day supply of 0.2% chlorhexidine (CHX) containing 0.2% hyaluronic acid (HA) and Anti-Discoloration System (ADS) according to the randomization list, and were instructed to use 10 ml of the assigned mouthrinse for 1 minute, t.i.d. for 21 days. After rinsing, patients were asked to avoid washing their mouth or drinking for 30 minutes. Patients were asked to return the mouthrinse bottles (either empty of filled) at the end of the experimental period (day 21), in order to assess the level of patient compliance with the assigned CHX regimen.
Time frame: GHI was evaluated at 7 days following surgery.
The healing process was evaluated at experimental teeth using a composite index, namely the Gingival Healing Index (GHI), which was created specifically to assess the post-surgery conditions of the interdental papilla. Briefly, the interdental papillae of experimental teeth were visually inspected, and a score was assigned for the severity of wound dehiscence (1-3) and the profile of the buccal and oral aspects of the papilla (1-3). For each patient, GHI score was obtained as the sum of the scores of each variable. Therefore, GHI ranged from 2 (worst quality of healing) to 6 (optimal quality of healing).
Time frame: GI was evaluated immediately before surgery and at 7 and 21 days following surgery.
Time frame: AngBS was evaluated immediately before surgery and at 7 and 21 days following surgery.
Time frame: PlI was evaluated immediately before surgery and at 7 and 21 days following surgery.
Time frame: Stain Index was evaluated immediately before surgery and at 7 and 21 days following surgery.
Time frame: Tongue stain was evaluated immediately before surgery and at 7 and 21 days following surgery.
Time frame: GHI was re-evaluated at 21 days following surgery.
The healing process was evaluated at experimental teeth using a composite index, namely the Gingival Healing Index (GHI), which was created specifically to assess the post-surgery conditions of the interdental papilla. Briefly, the interdental papillae of experimental teeth were visually inspected, and a score was assigned for the severity of wound dehiscence (1-3) and the profile of the buccal and oral aspects of the papilla (1-3). For each patient, GHI score was obtained as the sum of the scores of each variable. Therefore, GHI ranged from 2 (worst quality of healing) to 6 (optimal quality of healing).
University Hospital of Ferrara
Other
Clinical Efficacy of Chlorhexidine-based Mouthrinse Formulations in Patients Undergoing Flap Surgery: a Triple Blind, Parallel-arm, Randomized Controlled Trial
Acronym: CHX+HA+ADS
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