Periodontal DiseasesHOCl-Post-AANCT05952921
Comparison of the Effectiveness of Hypochlorous Acid and Chlorhexidine as a Post-surgical Antimicrobial Agent
A study testing Mouthwash and Chlorhexidine in people with Periodontal Diseases and Chronic Periodontitis, run by Universidad El Bosque, Bogotá at 1 site in Colombia.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases, Chronic Periodontitis, Microbial Colonization
- What is being tested?
- Mouthwash and Chlorhexidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteColombia
- Study dates
- 10 Jul 2019to 15 Dec 2019
- 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Mouthwash, Chlorhexidine
- Keywords
- Chlorhexidine, HOCl, bacterial recolonization, antiplaque
- Medical subject headings
- Periodontal Diseases, Chronic Periodontitis, Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MouthwashOther
Concentration rinse with 0.05% HOCl
ChlorhexidineOther
A high concentration of 0.2% CHX (7 days), followed by 0.012% CHX (14 days).
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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). Receives: Other: Chlorhexidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plaque Index (PI)
Presence or absence of visible plaque evaluated with a periodontal probe
Measured: Baseline
Plaque Index (PI)
Presence or absence of visible plaque evaluated with a periodontal probe
Measured: 7 days
Plaque Index (PI)
Presence or absence of visible plaque evaluated with a periodontal probe
Measured: 21 days
Plaque Index (PI)
Presence or absence of visible plaque evaluated with a periodontal probe
Measured: 90 days
Gingival index (GI)
Presence or absence of changes in gingiva color
Measured: Baseline
Gingival index (GI)
Presence or absence of changes in gingiva color
Measured: 7 days
Gingival index (GI)
Presence or absence of changes in gingiva color
Measured: 21 days
Gingival index (GI)
Presence or absence of changes in gingiva color
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 90 days
Bleeding on probing (BOP)
Presence of bleeding at the examined site up to 10 seconds after the examination.
Measured: Baseline
Bleeding on probing (BOP)
Presence of bleeding at the examined site up to 10 seconds after the examination.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 90 days
Secondary outcomes (2)
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.
Measured: 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.
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2023
- Study start10 Jul 2019
- Primary completion1 Dec 2019
- Study completion15 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Periodontal DiseasesStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad El Bosque, Bogotá
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Díaz-Báez, Universidad El Bosque, Bogotá
- Investigators
- Julio Plata, DDS MSc, Principal investigator, Universidad El BosqueGloria Lafaurie, DDS MSc, Study director, Unit of Basic Oral Investigation (UIBO) - Universidad El BosqueDavid Díaz-Báez, DDS MSc, Principal investigator, Unit of Basic Oral Investigation (UIBO) - Universidad El Bosque
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05952921
- Sponsor's protocol ID
- UnBosque-HOCl-003
- Acronym
- HOCl-Post-AA
- Status last verified
- Jul 2023
- First submitted
- 30 Jun 2023
- Last updated
- 19 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 26647939Lafaurie 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.
PubMed 29608039
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypochlorous Acid as a Potential Postsurgical Antimicrobial Agent in Periodontitis. A Non-inferiority Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT05952921
- Acronym / sponsor ID
- HOCl-Post-AA / UnBosque-HOCl-003
- Keywords
- Chlorhexidine, HOCl, bacterial recolonization, antiplaque
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Universidad El Bosque, BogotáUniversity, hospital or other
- Study start
- 10 Jul 2019 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 15 Dec 2019 (actual)
- First posted
- 19 Jul 2023 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypochlorous acid | Experimental | Other: MouthwashThirty-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) |
| Chlorhexidine | Active comparator | Other: ChlorhexidineThirty-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). |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
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 |
|---|---|---|
| MouthwashConcentration rinse with 0.05% HOCl | Other | Hypochlorous acid |
| ChlorhexidineA high concentration of 0.2% CHX (7 days), followed by 0.012% CHX (14 days). | Other | Chlorhexidine |
Primary outcome
Plaque Index (PI)
Time frame: Baseline
Presence or absence of visible plaque evaluated with a periodontal probe
Plaque Index (PI)
Time frame: 7 days
Presence or absence of visible plaque evaluated with a periodontal probe
Plaque Index (PI)
Time frame: 21 days
Presence or absence of visible plaque evaluated with a periodontal probe
Plaque Index (PI)
Time frame: 90 days
Presence or absence of visible plaque evaluated with a periodontal probe
Gingival index (GI)
Time frame: Baseline
Presence or absence of changes in gingiva color
Gingival index (GI)
Time frame: 7 days
Presence or absence of changes in gingiva color
Gingival index (GI)
Time frame: 21 days
Presence or absence of changes in gingiva color
Gingival index (GI)
Time frame: 90 days
Presence or absence of changes in gingiva color
Periodontal pocket depth (PD)
Time frame: Baseline
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
Periodontal pocket depth (PD)
Time frame: 90 days
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
Clinical attachment level (CAL)
Time frame: Baseline
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.
Clinical attachment level (CAL)
Time frame: 90 days
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.
Bleeding on probing (BOP)
Time frame: Baseline
Presence of bleeding at the examined site up to 10 seconds after the examination.
Bleeding on probing (BOP)
Time frame: 90 days
Presence of bleeding at the examined site up to 10 seconds after the examination.
Microbiological evaluation
Time frame: Baseline
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
Microbiological evaluation
Time frame: 7 days
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
Microbiological evaluation
Time frame: 21 days
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
Microbiological evaluation
Time frame: 90 days
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
2 secondary outcomes
Adverse effects
Time frame: 7 days
Adverse effects
Time frame: 21 days
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 19 Jul 2023.
- Background: PubMed 26647939Castillo 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.
- Background: PubMed 29608039Lafaurie 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.
- Individual participant dataSharing planned: No
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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.
Julio Plata, DDS MSc principal investigator
Universidad El Bosque
Gloria Lafaurie, DDS MSc study director
Unit of Basic Oral Investigation (UIBO) - Universidad El Bosque
David Díaz-Báez, DDS MSc principal investigator
Unit of Basic Oral Investigation (UIBO) - Universidad El Bosque
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mouthwash and Chlorhexidine in people with Periodontal Diseases and Chronic Periodontitis, run by Universidad El Bosque, Bogotá at 1 site in Colombia.
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 6 inclusion and 6 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 19 Jul 2023. 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 Colombia. 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?
Plaque Index (PI) (time frame: Baseline). The study lists 18 primary outcomes in all. 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 NCT05952921, which also lists 2 linked publications.
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 19 Jul 2023.