Periodontal Wound Healing With CHX and Hyaluronic Acid

Not Applicable

Completed

• Conditions: Surgical Flaps; Wound Healing; Gingiva
• Interventions: Device: CHX; Device: CHX+HA+ADS

• Registration Number: NCT03465670
• Lead Sponsor: University Hospital of Ferrara

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12-16
• Primary Completion: 2017-06-14
• Study Completion: 2017-06-14
• Status Verified: 2018-03
• Study First Submitted: 2018-03-06
• Study First Submitted QC: 2018-03-13
• Last Update Submitted: 2018-03-13
• Study First Posted: 2018-03-14
• Last Update Posted: 2018-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CHX	CHX	Post-surgery use of a 0.2% chlorhexidine (CHX) mouthrinse (10 ml for 1 minute, t.i.d. for 21 days)
CHX+HA+ADS	CHX+HA+ADS	Post-surgery use of a 0.2% chlorhexidine (CHX) mouthrinse containing 0.2% hyaluronic acid (HA) and Anti-Discoloration System (ADS) (10 ml for 1 minute, t.i.d. for 21 days)

Primary Outcome Measures

Name	Time	Method
Gingival Healing Index	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).

Secondary Outcome Measures

Name	Time	Method
Tongue stain (Claydon et al. 2001)	Tongue stain was evaluated immediately before surgery and at 7 and 21 days following surgery.
Gingival Index (GI) (Löe & Silness 1963) modified by Trombelli et al. (2004)	GI was evaluated immediately before surgery and at 7 and 21 days following surgery.
Angulated bleeding score (AngBs) (van der Weijden et al. 1994) modified by Trombelli et al. (2004)	AngBS was evaluated immediately before surgery and at 7 and 21 days following surgery.
Intensity stain index of Lobene (1968) modified by Grundemann et al. (2000)	Stain Index was evaluated immediately before surgery and at 7 and 21 days following surgery.
Plaque index (PlI) (Quigley & Hein 1962) modified by Turesky et al. (1970)	PlI was evaluated immediately before surgery and at 7 and 21 days following surgery.
Gingival Healing Index	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).

Trial Locations

Locations (1)

University-Hospital; 🇮🇹 Ferrara, Italy