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Periodontal Wound Healing With CHX and Hyaluronic Acid (CHX+HA+ADS)

Primary Purpose

Surgical Flaps, Wound Healing, Gingiva

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
CHX
CHX+HA+ADS
Sponsored by
University Hospital of Ferrara
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Surgical Flaps focused on measuring chlorhexidine, hyaluronic acid, tooth discoloration

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

INCLUSION CRITERIA

Patients were included in the study if positive for each of the following patient related criteria:

  • 18 years or older;
  • able and willing to provide a written informed consent;
  • willing to grant the sufficient compliance with the experimental procedures.

Patients were included in the study if positive for each of the following surgery-related criteria (verified as part of their overall treatment plan):

  • indication to at least one session of oral surgery (including periodontal surgery, endodontic surgery, tooth extraction, and implant surgery) requiring the elevation of an envelope or triangular, full-thickness gingival/mucosal flap;
  • indication to flap extension to the interdental papilla between either the canine and first premolar or first and second premolar to enhance surgical visibility (teeth in this area were identified as the experimental teeth);
  • intact (i.e., no clinical attachment loss) or reduced periodontium with probing pocket depths ≤ 3 mm and no diastema at experimental teeth;
  • indication to the repositioning of the surgical flap at the pre-surgical level on the experimental teeth at suturing (i.e. no coronal advancement or apical displacement of the flap).

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:

  • pregnancy or lactation;
  • genetic defects (e.g. Down's syndrome) with an established impact on periodontal status;
  • diabetes mellitus;
  • immune system disorders (e.g. HIV/AIDS);
  • heavy smokers (≥ 10 cigarettes/day);
  • severe blood disorders, with a documented qualitative and/or quantitative deficit of polymorphonuclears and/or platelets;
  • assumption of medications affecting the gingiva and/or the oral mucosa (e.g. diphenylhydantoin, calcium channel blockers, cyclosporin A, immunostimulants/immunomodulators),
  • assumption of oral contraceptives;
  • use of systemic or local antibiotics in the previous 4 weeks before study initiation and throughout the entire experimental phase;
  • documented allergy to CHX and/or HA.

Patients were excluded from the study if the experimental teeth were positive for one or more of the following criteria:

  • dental treatment within the last two months;
  • presence of untreated caries or endodontic lesions;
  • presence of root fractures;
  • tooth alterations (i.e. amelogenesis imperfecta, tetracycline staining) impairing staining evaluations;
  • presence of inadequate restorations;
  • orthodontic appliances;
  • indication to mucogingival surgery.

Sites / Locations

  • University-Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

CHX

CHX+HA+ADS

Arm Description

Post-surgery use of a 0.2% chlorhexidine (CHX) mouthrinse (10 ml for 1 minute, t.i.d. for 21 days)

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)

Outcomes

Primary Outcome Measures

Gingival Healing Index
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

Gingival Index (GI) (Löe & Silness 1963) modified by Trombelli et al. (2004)
Angulated bleeding score (AngBs) (van der Weijden et al. 1994) modified by Trombelli et al. (2004)
Plaque index (PlI) (Quigley & Hein 1962) modified by Turesky et al. (1970)
Intensity stain index of Lobene (1968) modified by Grundemann et al. (2000)
Tongue stain (Claydon et al. 2001)
Gingival Healing Index
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).

Full Information

First Posted
March 6, 2018
Last Updated
March 13, 2018
Sponsor
University Hospital of Ferrara
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1. Study Identification

Unique Protocol Identification Number
NCT03465670
Brief Title
Periodontal Wound Healing With CHX and Hyaluronic Acid
Acronym
CHX+HA+ADS
Official Title
Clinical Efficacy of Chlorhexidine-based Mouthrinse Formulations in Patients Undergoing Flap Surgery: a Triple Blind, Parallel-arm, Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
December 16, 2015 (Actual)
Primary Completion Date
June 14, 2017 (Actual)
Study Completion Date
June 14, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital of Ferrara

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Flaps, Wound Healing, Gingiva
Keywords
chlorhexidine, hyaluronic acid, tooth discoloration

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Single-center, parallel-arm, triple-blind, randomized controlled clinical trial
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
The patient, the clinical operators as well as the clinical examiner were kept blinded with respect to treatment allocation until the termination of the study. To ensure blindness, CHX and CHX+HA+ADS mouthrinses were provided in identical, masked containers numbered according to the randomization sequence.
Allocation
Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CHX
Arm Type
Active Comparator
Arm Description
Post-surgery use of a 0.2% chlorhexidine (CHX) mouthrinse (10 ml for 1 minute, t.i.d. for 21 days)
Arm Title
CHX+HA+ADS
Arm Type
Experimental
Arm Description
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)
Intervention Type
Device
Intervention Name(s)
CHX
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
CHX+HA+ADS
Intervention Description
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.
Primary Outcome Measure Information:
Title
Gingival Healing Index
Description
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
GHI was evaluated at 7 days following surgery.
Secondary Outcome Measure Information:
Title
Gingival Index (GI) (Löe & Silness 1963) modified by Trombelli et al. (2004)
Time Frame
GI was evaluated immediately before surgery and at 7 and 21 days following surgery.
Title
Angulated bleeding score (AngBs) (van der Weijden et al. 1994) modified by Trombelli et al. (2004)
Time Frame
AngBS was evaluated immediately before surgery and at 7 and 21 days following surgery.
Title
Plaque index (PlI) (Quigley & Hein 1962) modified by Turesky et al. (1970)
Time Frame
PlI was evaluated immediately before surgery and at 7 and 21 days following surgery.
Title
Intensity stain index of Lobene (1968) modified by Grundemann et al. (2000)
Time Frame
Stain Index was evaluated immediately before surgery and at 7 and 21 days following surgery.
Title
Tongue stain (Claydon et al. 2001)
Time Frame
Tongue stain was evaluated immediately before surgery and at 7 and 21 days following surgery.
Title
Gingival Healing Index
Description
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
GHI was re-evaluated at 21 days following surgery.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
INCLUSION CRITERIA Patients were included in the study if positive for each of the following patient related criteria: 18 years or older; able and willing to provide a written informed consent; willing to grant the sufficient compliance with the experimental procedures. Patients were included in the study if positive for each of the following surgery-related criteria (verified as part of their overall treatment plan): indication to at least one session of oral surgery (including periodontal surgery, endodontic surgery, tooth extraction, and implant surgery) requiring the elevation of an envelope or triangular, full-thickness gingival/mucosal flap; indication to flap extension to the interdental papilla between either the canine and first premolar or first and second premolar to enhance surgical visibility (teeth in this area were identified as the experimental teeth); intact (i.e., no clinical attachment loss) or reduced periodontium with probing pocket depths ≤ 3 mm and no diastema at experimental teeth; indication to the repositioning of the surgical flap at the pre-surgical level on the experimental teeth at suturing (i.e. no coronal advancement or apical displacement of the flap). 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: pregnancy or lactation; genetic defects (e.g. Down's syndrome) with an established impact on periodontal status; diabetes mellitus; immune system disorders (e.g. HIV/AIDS); heavy smokers (≥ 10 cigarettes/day); severe blood disorders, with a documented qualitative and/or quantitative deficit of polymorphonuclears and/or platelets; assumption of medications affecting the gingiva and/or the oral mucosa (e.g. diphenylhydantoin, calcium channel blockers, cyclosporin A, immunostimulants/immunomodulators), assumption of oral contraceptives; use of systemic or local antibiotics in the previous 4 weeks before study initiation and throughout the entire experimental phase; documented allergy to CHX and/or HA. Patients were excluded from the study if the experimental teeth were positive for one or more of the following criteria: dental treatment within the last two months; presence of untreated caries or endodontic lesions; presence of root fractures; tooth alterations (i.e. amelogenesis imperfecta, tetracycline staining) impairing staining evaluations; presence of inadequate restorations; orthodontic appliances; indication to mucogingival surgery.
Facility Information:
Facility Name
University-Hospital
City
Ferrara
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No

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Periodontal Wound Healing With CHX and Hyaluronic Acid

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