Comparison of the Effectiveness of Hypochlorous Acid and Chlorhexidine as a Post-surgical Antimicrobial Agent (HOCl-Post-AA)

Hypochlorous Acid as a Potential Postsurgical Antimicrobial Agent in Periodontitis. A Non-inferiority Randomized Controlled Trial.

The aim of the study is to evaluate the effectiveness of Hypochlorous Acid and Chlorhexidine as postsurgical antimicrobial agents in the treatment of severe chronic periodontal disease. The selected patients will be randomly divided into two groups of 16 each. Subjects in group I will undergo scaling and surgical root planing and will use mouthrinse with 0.05% HOCl for 7 days, after this they will mouthwash with 0.025% HOCl until day 21 and Subjects in group II will undergo scaling and surgical root planing followed by a rinse with CHX 0.2% for 7 days, after this they will mouthwash with 0.12% CHX until day 21. Null Hypothesis: There are no significant differences between hypochlorous acid and chlorhexidine in reducing plaque formation at 7, 21 and 90 days of evaluation.

There are no significant differences between HOCl and CHX in the elimination or reduction of periodontopathogenic microorganisms at 7, 21 and 90 days. Alternative hypotheses: There are significant differences between hypochlorous acid and chlorhexidine in reducing plaque formation at 7, 21 and 90 days of evaluation. There are significant differences between HOCl and CHX in the elimination or reduction of periodontopathogenic microorganisms at 7, 21 and 90 days.

Study Overview

• Status: Completed
• Conditions: Periodontal Diseases; Microbial Colonization; Chronic Periodontitis
• Intervention / Treatment: Other: Mouthwash; Other: Chlorhexidine

Detailed Description

For the HOCl effectiveness study, parallel groups were compared to determine the clinical and microbiological effectiveness of hypochlorous acid by evaluating the reduction of plaque index, gingival index and clinical insertion level as a primary outcome with chlorhexidine, for a period of 7, 21 and 90 days. The selected patients will be randomly divided into two groups of 16 each. Subjects in group I: 16 subjects for scaling and surgical root planing (surgical technique Modified Widman) and HOCl 0.05% for 7 days and HOCl 0.025% until day 21 and Subjects in group II: 16 subjects for scaling and surgical root planing (surgical technique Modified Widman) and CHX 0.2% for 7 days and 0.12% CHX until day 21. At the beginning of the study (day0) all patients will be evaluated the plaque index, gingival index, periodontal chart, saliva sample collection and subgingival microbiological test, all will receive surgical periodontal treatment (scaling and surgical root planing surgical technique Modified Widman) after the surgery will be instructed to rinse with 15 ml twice a day for 30 seconds in the morning 30 minutes after breakfast and brushing teeth, and at night, before going to sleep with one of the two Rinses: HOCl 0.05% for the first seven days and 0.025% from day eight to day 21 and CHX 0.2% for the first seven days and 0.12% from day eight to day 21. The rinses were coded to avoid any bias and the codes will not be broken before the study ends. Patients will be assigned randomly each will receive a flushing flask identified as solution "A" or "B". These bottles will be identical in terms of shape, color and material. Neither the subject nor the dentists will be informed about the group assignment. The principal investigator who does not participate in the treatment or data collection will have access to a closed envelope with the allocation information. Each of the participants will be clear that the area where the surgical procedure should be performed should remain unbrushed for 21 days. After 21 days all individuals will be given a special toothbrush for after surgery and indications are given for the brushing of the operated area. Adverse effects were evaluated both microbiologically to verify the absence or presence of opportunistic flora associated with the use of mouthwashes and effects on teeth and mucous membranes using a survey and clinical assessment.

The data will be collected as follows:

Day zero will evaluate plaque and gingival index, periodontal pocket depth al probing, clinical insertion level, saliva uptake and subgingival sampling for microbiological analysis. On day 7 suture removal and plaque and gingival index, saliva sampling and subgingival sampling for microbiological analysis were evaluated. On day 21, plaque and gingival index, saliva sampling and subgingival sampling will be evaluated for microbiological analysis. And on day 90, plaque and gingival index, periodontal pocket depth at probing, clinical insertion level, saliva sampling and subgingival sampling for microbiological analysis.

For the test the following parameters will be evaluated: Gingival Index and Plaque Index. The modified gingival index and the modified visible plaque index will be evaluated. Four evaluations will be performed: one at the beginning of the study, another at day 7, 21 and the last at day 90 and the Index of visible plaque and Gingival index (Modified Silness & Loe) will be used. The probing depth and the level of clinical insertion will be measured in six sites per tooth (mesiobuccal, buccal, distobuccal, distolingual, lingual and mesiolingual) exclusion of the third molar, on day 0 and 90. Measurements will be recorded in the periodontal chart and a North Carolina periodontal probe (Hu-Friedy, Chicago, IL, USA) will be used. Sampling of saliva and microbial count: Microbiological samples in saliva and subgingival will be collected before surgery (day 0) and after surgery at day 7, 21 and 90. For the sampling of subgingival bacteria, the selected sites were cleaned (sterile curettes) before sampling, with cotton roll the field is isolated and dried carefully to avoid contamination, bacterial samples will be collected with paper tips of endodontics sterile (size 55 absorbent paper, Dentsply, Maillefer). Samples will be individually placed in labeled Eppendorf tubes containing Buffer, kept at -70°C and then sent to the laboratory. Will be processed in the laboratory of Oral Microbiology of the Universidad el Bosque. Samples will be analyzed using the real-time PCR technique.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Colombia
  • Bogotá, Colombia, 110011
    • Universidad El Bosque

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Men and women.
• Age between 20 and 60 years.
• Diagnosis of chronic periodontitis.
• Minimum 20 teeth and minimum 3 teeth with at least one site with PD≥5 mm and CAL> 4 mm
• Radiographic evidence of bone loss.
• Good general health.

Exclusion Criteria:

• Prior periodontal therapy.
• Smokers.
• Antibiotic therapy in the last 4 months, consumption of NSAIDs.
• Pregnancy and / or breastfeeding.
• Systemic pathology that may affect the progression of PD.
• Allergy to HOCl or CHX.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hypochlorous acid; Thirty-two voluntary participants were randomly assigned to receive one of two post-surgical protocols after periodontal surgery: a high concentration rinse with 0.05% HOCl (7 days), followed by 0.025% HOCl /(14 days)	Other: Mouthwash; Concentration rinse with 0.05% HOCl
Active Comparator: Chlorhexidine; Thirty-two voluntary participants were randomly assigned to receive one of two post-surgical protocols after periodontal surgery: a high concentration of 0.2% CHX (7 days), followed by 0.012% CHX (14 days).	Other: Chlorhexidine; A high concentration of 0.2% CHX (7 days), followed by 0.012% CHX (14 days).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plaque Index (PI)	Presence or absence of visible plaque evaluated with a periodontal probe	Baseline
Plaque Index (PI)	Presence or absence of visible plaque evaluated with a periodontal probe	7 days
Plaque Index (PI)	Presence or absence of visible plaque evaluated with a periodontal probe	21 days
Plaque Index (PI)	Presence or absence of visible plaque evaluated with a periodontal probe	90 days
Gingival index (GI)	Presence or absence of changes in gingiva color	Baseline
Gingival index (GI)	Presence or absence of changes in gingiva color	7 days
Gingival index (GI)	Presence or absence of changes in gingiva color	21 days
Gingival index (GI)	Presence or absence of changes in gingiva color	90 days
Periodontal pocket depth (PD)	Depth in millimeters with a North Carolina periodontal probe (Hu-Friedy, Chicago, IL, USA) at six sites per tooth (mesiobuccal, buccal, distobuccal, distolingual, lingual, and mesiolingual), excluding third molar	Baseline
Periodontal pocket depth (PD)	Depth in millimeters with a North Carolina periodontal probe (Hu-Friedy, Chicago, IL, USA) at six sites per tooth (mesiobuccal, buccal, distobuccal, distolingual, lingual, and mesiolingual), excluding third molar	90 days
Clinical attachment level (CAL)	Depth in millimeters with a North Carolina periodontal probe (Hu-Friedy, Chicago, IL, USA) at six sites per tooth (mesiobuccal, buccal, distobuccal, distolingual, lingual, and mesiolingual), except the third molar. Distance in millimeters from the cementoenamel limit to the bottom of the sulcus/periodontal pocket.	Baseline
Clinical attachment level (CAL)	Depth in millimeters with a North Carolina periodontal probe (Hu-Friedy, Chicago, IL, USA) at six sites per tooth (mesiobuccal, buccal, distobuccal, distolingual, lingual, and mesiolingual), except the third molar. Distance in millimeters from the cementoenamel limit to the bottom of the sulcus/periodontal pocket.	90 days
Bleeding on probing (BOP)	Presence of bleeding at the examined site up to 10 seconds after the examination.	Baseline
Bleeding on probing (BOP)	Presence of bleeding at the examined site up to 10 seconds after the examination.	90 days
Microbiological evaluation	Real-time PCR with absolute quantification to confirm the number of colony-forming units (CFU) of bacterial samples from the six sites with the highest PD; specifically P gingivalis, T denticola, T forsythia, E nodatum and A. actinomycetemcomitans	Baseline
Microbiological evaluation	Real-time PCR with absolute quantification to confirm the number of colony-forming units (CFU) of bacterial samples from the six sites with the highest PD; specifically P gingivalis, T denticola, T forsythia, E nodatum and A. actinomycetemcomitans	7 days
Microbiological evaluation	Real-time PCR with absolute quantification to confirm the number of colony-forming units (CFU) of bacterial samples from the six sites with the highest PD; specifically P gingivalis, T denticola, T forsythia, E nodatum and A. actinomycetemcomitans	21 days
Microbiological evaluation	Real-time PCR with absolute quantification to confirm the number of colony-forming units (CFU) of bacterial samples from the six sites with the highest PD; specifically P gingivalis, T denticola, T forsythia, E nodatum and A. actinomycetemcomitans	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse effects	A survey was carried out on each participant at 7 and 21 days of the study to identify clinical adverse effects such as burning sensation, burning or pain in the oral mucosa, sensation of dryness or dryness, and changes in the perception of taste or the color in the teeth.	7 days
Adverse effects	A survey was carried out on each participant at 7 and 21 days of the study to identify clinical adverse effects such as burning sensation, burning or pain in the oral mucosa, sensation of dryness or dryness, and changes in the perception of taste or the color in the teeth.	21 days

Collaborators and Investigators

• Sponsor: Universidad El Bosque, Bogotá
• Investigators: Principal Investigator: Julio Plata, DDS MSc, Universidad El Bosque; Study Director: Gloria Lafaurie, DDS MSc, Unit of Basic Oral Investigation (UIBO) - Universidad El Bosque; Principal Investigator: David Díaz-Báez, DDS MSc, Unit of Basic Oral Investigation (UIBO) - Universidad El Bosque

Publications and helpful links

General Publications

• Castillo DM, Castillo Y, Delgadillo NA, Neuta Y, Jola J, Calderon JL, Lafaurie GI. Viability and Effects on Bacterial Proteins by Oral Rinses with Hypochlorous Acid as Active Ingredient. Braz Dent J. 2015 Oct;26(5):519-24. doi: 10.1590/0103-6440201300388.
• Lafaurie GI, Zaror C, Diaz-Baez D, Castillo DM, De Avila J, Trujillo TG, Calderon-Mendoza J. Evaluation of substantivity of hypochlorous acid as an antiplaque agent: A randomized controlled trial. Int J Dent Hyg. 2018 Nov;16(4):527-534. doi: 10.1111/idh.12342. Epub 2018 Apr 2.

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2019
• Primary Completion (Actual): December 1, 2019
• Study Completion (Actual): December 15, 2019

Study Registration Dates

• First Submitted: June 30, 2023
• First Submitted That Met QC Criteria: July 17, 2023
• First Posted (Actual): July 19, 2023

Study Record Updates

• Last Update Posted (Actual): July 19, 2023
• Last Update Submitted That Met QC Criteria: July 17, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Chlorhexidine; antiplaque; HOCl; bacterial recolonization
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Stomatognathic Diseases; Mouth Diseases; Chronic Disease; Periodontitis; Infections; Communicable Diseases; Periodontal Diseases; Chronic Periodontitis; Anti-Infective Agents, Local; Anti-Infective Agents; Disinfectants; Chlorhexidine
• Other Study ID Numbers: UnBosque-HOCl-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No