Surgical FlapsCHX+HA+ADSNCT03465670

Periodontal Wound Healing With CHX and Hyaluronic Acid

A study testing CHX and CHX+HA+ADS in people with Surgical Flaps and Wound Healing, run by University Hospital of Ferrara at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Surgical Flaps, Wound Healing, Gingiva
What is being tested?: CHX and CHX+HA+ADS
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 37 participants
Where: 1 siteItaly
Study dates: 16 Dec 2015to 14 Jun 2017
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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;

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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).

Who cannot join

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);

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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.

Trial locations and contacts

1 site in 1 country.

Italy1 site

University-Hospital
Ferrara

Other trials in Italy

About this study

Official title: Clinical Efficacy of Chlorhexidine-based Mouthrinse Formulations in Patients Undergoing Flap Surgery: a Triple Blind, Parallel-arm, Randomized Controlled Trial

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.

Conditions: Surgical Flaps, Wound Healing, Gingiva
Being tested: CHX, CHX+HA+ADS
Keywords: chlorhexidine, hyaluronic acid, tooth discoloration
Medical subject headings: Tooth Discoloration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CHXDevice
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.
CHX+HA+ADSDevice
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.

Study groups in NCT03465670
Study group	Role	What they receive
CHX	Active comparator	Post-surgery use of a 0.2% chlorhexidine (CHX) mouthrinse (10 ml for 1 minute, t.i.d. for 21 days) Receives: Device: CHX
CHX+HA+ADS	Experimental	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) Receives: Device: CHX+HA+ADS

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: GHI was evaluated at 7 days following surgery.

Secondary outcomes (6)

Gingival Index (GI) (Löe & Silness 1963) modified by Trombelli et al. (2004)
Measured: 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)
Measured: AngBS 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)
Measured: PlI 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)
Measured: Stain Index was evaluated immediately before surgery and at 7 and 21 days following surgery.
Tongue stain (Claydon et al. 2001)
Measured: Tongue stain was evaluated immediately before surgery and at 7 and 21 days following surgery.
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).
Measured: GHI was re-evaluated at 21 days following surgery.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Dec 201514 Jun 2017

First posted14 Mar 2018
Study start16 Dec 2015
Primary completion14 Jun 2017
Study completion14 Jun 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Surgical FlapsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Model description: Single-center, parallel-arm, triple-blind, randomized controlled clinical trial
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 37 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03465670
Sponsor's protocol ID: CHX+HA+ADS
Acronym: CHX+HA+ADS
Status last verified: Mar 2018
First submitted: 6 Mar 2018
Last updated: 14 Mar 2018
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Surgical Flaps trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Efficacy of Chlorhexidine-based Mouthrinse Formulations in Patients Undergoing Flap Surgery: a Triple Blind, Parallel-arm, Randomized Controlled Trial
ClinicalTrials.gov ID: NCT03465670
Acronym / sponsor ID: CHX+HA+ADS / CHX+HA+ADS
Conditions: Surgical Flaps, Wound Healing, Gingiva
Keywords: chlorhexidine, hyaluronic acid, tooth discoloration
Study type: Interventional
Recruitment status: Completed
Enrolment: 37 participants (actual)
Lead sponsor: University Hospital of FerraraUniversity, hospital or other
Study start: 16 Dec 2015 (actual)
Primary completion: 14 Jun 2017 (actual)
Study completion: 14 Jun 2017 (actual)
First posted: 14 Mar 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2
Model description: Single-center, parallel-arm, triple-blind, randomized controlled clinical trial

Arm	Type	Receives
CHX	Active comparator	Device: CHXPost-surgery use of a 0.2% chlorhexidine (CHX) mouthrinse (10 ml for 1 minute, t.i.d. for 21 days)
CHX+HA+ADS	Experimental	Device: CHX+HA+ADSPost-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)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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):

Key exclusion criteria (19 listed)

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);

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CHXPatients 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.	Device	CHX
CHX+HA+ADSPatients 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.	Device	CHX+HA+ADS

Primary outcome

Gingival Healing Index
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).

6 secondary outcomes

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.
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.
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.
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.
Tongue stain (Claydon et al. 2001)
Time frame: Tongue stain was evaluated immediately before surgery and at 7 and 21 days following surgery.
Gingival Healing Index
Time frame: GHI was re-evaluated at 21 days following surgery.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2018.
Individual participant dataSharing planned: No

Related trials for Surgical Flaps

RecruitingPhase 4
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RecruitingPhase 4
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing CHX and CHX+HA+ADS in people with Surgical Flaps and Wound Healing, run by University Hospital of Ferrara at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Gingival Healing Index (time frame: GHI was evaluated at 7 days following surgery.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03465670.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2018.