Comparison of the Effectiveness of Hypochlorous Acid and Chlorhexidine as a Post-surgical Antimicrobial Agent

NCT05952921 | Completed DMC

• 1 other identifier: UnBosque-HOCl-003
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Periodontal Diseases; Chronic Periodontitis; Microbial Colonization

Keywords

Chlorhexidine; HOCl; bacterial recolonization; antiplaque

Outcome Measures

Primary Outcomes (18)

• 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 Outcomes (2)

• Adverse effects

  7 days

• Adverse effects

  21 days

Study Arms (2)

Hypochlorous acid

EXPERIMENTAL

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

Chlorhexidine

ACTIVE COMPARATOR

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

Interventions

Mouthwash OTHER

Concentration rinse with 0.05% HOCl

Hypochlorous acid

Chlorhexidine OTHER

A high concentration of 0.2% CHX (7 days), followed by 0.012% CHX (14 days).

Chlorhexidine

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad El Bosque, Bogotá: lead

Study Sites (1)

Universidad El Bosque

Bogotá, 110011, Colombia

Location

Related Publications (2)

• 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.

  PMID: 26647939 BACKGROUND

• 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.

  PMID: 29608039 BACKGROUND

MeSH Terms

Conditions

Periodontal Diseases; Chronic Periodontitis; Communicable Diseases

Interventions

Mouthwashes; Chlorhexidine

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Periodontitis; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infections

Intervention Hierarchy (Ancestors)

Biomedical and Dental Materials; Specialty Uses of Chemicals; Chemical Actions and Uses; Cosmetics; Manufactured Materials; Technology, Industry, and Agriculture; Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Julio Plata, DDS MSc

  Universidad El Bosque

  PRINCIPAL INVESTIGATOR

• Gloria Lafaurie, DDS MSc

  Unit of Basic Oral Investigation (UIBO) - Universidad El Bosque

  STUDY DIRECTOR

• David Díaz-Báez, DDS MSc

  Unit of Basic Oral Investigation (UIBO) - Universidad El Bosque

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The rinses will be coded to avoid any bias and the codes will not be broken before the study ends. Patients will be randomly assigned to receive a rinse bottle 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: June 30, 2023
• First Posted: July 19, 2023
• Study Start: July 10, 2019
• Primary Completion: December 1, 2019
• Study Completion: December 15, 2019
• Last Updated: July 19, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)