Wound HealingNCT06760403
Efficacy of Hypochlorous Acid as a Postoperative Wound Antiseptic
A study testing Hypochlorous acid in people with Wound Healing, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
The aim was to examine the effectiveness of hypochlorous acid on postoperative wound healing in 24 systemically healthy gingivectomy participants aged 12-30. The participants were divided into 3 groups as hypochlorous acid group, chlorhexidine group and saline group and their wound healing was evaluated on the 1st… Read more about this study
- Who is it for?
- Ages 12 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Wound Healing
- What is being tested?
- Hypochlorous acid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 May 2023to 1 Dec 2023
- 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 12 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Gingival overgrowth affecting at least six teeth symmetrically in the mandibular or maxillary anterior area
- No attachment and bone loss
- 7 days before the surgery, full-mouth plaque index (PI) < 25% and a full-mouth gingival bleeding index (GBI) < 25%.
- the keratinized tissues surrounding the teeth are at least 2 mm wide.
Who cannot join
- Smoking or alcohol use
- Patients who have undergone systemic antimicrobial therapy and surgical procedures within the last 3 months
- Pregnancy or lactation
- Immunodeficiency or immunosuppressive drug therapy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Atatürk University Faculty of Dentistry
Erzurum, 25240
About this study
Official title: Investigation of the Efficacy of Hypochlorous Acid as a Postoperative Wound Antiseptic: A Randomized Controlled Pilot Study
The aim was to examine the effectiveness of hypochlorous acid on postoperative wound healing in 24 systemically healthy gingivectomy participants aged 12-30. The participants were divided into 3 groups as hypochlorous acid group, chlorhexidine group and saline group and their wound healing was evaluated on the 1st, 3rd and 7th days.
Read the detailed description
The aim of this study was to investigate the effectiveness of hypochlorous acid on postoperative wound healing in 24 participants aged 12-30 who underwent gingivectomy involving the 6 anterior teeth of the upper or lower jaw with chronic inflammatory gingival overgrowth. The participants were divided into 3 groups as hypochlorous acid group, chlorhexidine group and saline group and were called for control on the 1st, 3rd and 7th days to evaluate wound healing. Periodontal indexes, visual analog scale (VAS), H2O2, plaque staining agent test, and histological analyzes were used to evaluate wound healing. The data were analyzed statistically.
- Conditions
- Wound Healing
- Being tested
- Hypochlorous acid
- Keywords
- gingival overgrowth, gingivoplasty, gingivectomy, hypochlorous acid, chlorhexidine
- Medical subject headings
- Gingival Overgrowth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypochlorous acidDrug
Hypochlorous acid, chlorhexidine and saline groups were compared as postoperative gargles after gingivectomy surgery.
| Study group | Role | What they receive |
|---|---|---|
| Hypochlorous Group | Experimental | In the hypochlorous acid group, 15 ml was used as a postoperative gargle, 2 times * 7 days. Receives: Drug: Hypochlorous acid |
| Chlorhexidine Group | Active comparator | In the clorhexidine group, 15 ml was used as a postoperative gargle, 2 times * 7 days. Receives: Drug: Hypochlorous acid |
| Saline Group | Placebo comparator | In the saline group, 15 ml was used as a postoperative gargle, 2 times * 7 days. Receives: Drug: Hypochlorous acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plaque index
The amount of plaque was scored.
Measured: Baseline, Day 7
Gingival index
The gingival status was scored.
Measured: Baseline, Day 7
Probing depth
The periodontal pocket depth was performed (mm).
Measured: Baseline, Day 7
Clinical attachment level
The clinical attachment level was measured (mm).
Measured: Baseline, Day 7
Bleeding on probing
The gingival status was scored.(%)
Measured: Baseline, Day 7
Epithelialization with plaque staining agent
The wound surface epithelialization was observed with plaque staining agent. The wound surface was stained with plaque staining dye and the dark colored area is calculated as mm2.
Measured: Day 1, 3, and 7
Epithelialization with H2O2
The wound surface epithelialization was observed with H2O2. Scored as foaming present/absent after application with H2O2
Measured: Day 3 and 7
Histological analysis
Histological analysis evaluated epithelial keratinization, regeneration, and/or degeneration during the healing process and to obtain epithelial samples repeatedly. The number of keratinocytes was counted.
Measured: Day 1, 3, and 7
postoperative pain with Visiual Analogue Scale (VAS)
VAS scores were taken on the 3rd and 7th days without any intervention to the patient. Scored between 1-10 as 1 was no pain, 10 was pain.
Measured: Day 3 and 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2025
- Study start2 May 2023
- Primary completion2 Oct 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Wound HealingStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- 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
- Model description
- The study included 24 systemically healthy individuals who were randomly divided into three groups: 1) Hypochlorous acid, 2) Chlorhexidine, and 3) Saline.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sema Nur Sevinc, Ataturk University
- Investigators
- Sema Nur Sevinç Gül, Dr., Principal investigator, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06760403
- Sponsor's protocol ID
- MCT4
- Status last verified
- Jan 2025
- First submitted
- 24 Dec 2024
- Last updated
- 6 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Burian EA, Sabah L, Kirketerp-Moller K, Gundersen G, Agren MS. Effect of Stabilized Hypochlorous Acid on Re-epithelialization and Bacterial Bioburden in Acute Wounds: A Randomized Controlled Trial in Healthy Volunteers. Acta Derm Venereol. 2022 May 31;102:adv00727. doi: 10.2340/actadv.v102.1624.
PubMed 35578822
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Efficacy of Hypochlorous Acid as a Postoperative Wound Antiseptic: A Randomized Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT06760403
- Acronym / sponsor ID
- MCT4
- Conditions
- Wound Healing
- Keywords
- gingival overgrowth, gingivoplasty, gingivectomy, hypochlorous acid, chlorhexidine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 2 May 2023 (actual)
- Primary completion
- 2 Oct 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 6 Jan 2025 (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 was to examine the effectiveness of hypochlorous acid on postoperative wound healing in 24 systemically healthy gingivectomy participants aged 12-30. The participants were divided into 3 groups as hypochlorous acid group, chlorhexidine group and saline group and their wound healing was evaluated on the 1st, 3rd and 7th days.
Detailed description
The aim of this study was to investigate the effectiveness of hypochlorous acid on postoperative wound healing in 24 participants aged 12-30 who underwent gingivectomy involving the 6 anterior teeth of the upper or lower jaw with chronic inflammatory gingival overgrowth. The participants were divided into 3 groups as hypochlorous acid group, chlorhexidine group and saline group and were called for control on the 1st, 3rd and 7th days to evaluate wound healing. Periodontal indexes, visual analog scale (VAS), H2O2, plaque staining agent test, and histological analyzes were used to evaluate wound healing. The data were analyzed statistically.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- The study included 24 systemically healthy individuals who were randomly divided into three groups: 1) Hypochlorous acid, 2) Chlorhexidine, and 3) Saline.
| Arm | Type | Receives |
|---|---|---|
| Hypochlorous Group | Experimental | Drug: Hypochlorous acidIn the hypochlorous acid group, 15 ml was used as a postoperative gargle, 2 times * 7 days. |
| Chlorhexidine Group | Active comparator | Drug: Hypochlorous acidIn the clorhexidine group, 15 ml was used as a postoperative gargle, 2 times * 7 days. |
| Saline Group | Placebo comparator | Drug: Hypochlorous acidIn the saline group, 15 ml was used as a postoperative gargle, 2 times * 7 days. |
Who may qualify
- Ages
- 12 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Gingival overgrowth affecting at least six teeth symmetrically in the mandibular or maxillary anterior area
- No attachment and bone loss
- 7 days before the surgery, full-mouth plaque index (PI) < 25% and a full-mouth gingival bleeding index (GBI) < 25%.
- the keratinized tissues surrounding the teeth are at least 2 mm wide.
Key exclusion criteria (4 listed)
- Smoking or alcohol use
- Patients who have undergone systemic antimicrobial therapy and surgical procedures within the last 3 months
- Pregnancy or lactation
- Immunodeficiency or immunosuppressive drug therapy
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 |
|---|---|---|
| Hypochlorous acidHypochlorous acid, chlorhexidine and saline groups were compared as postoperative gargles after gingivectomy surgery. | Drug | Chlorhexidine Group, Hypochlorous Group, Saline Group |
Primary outcome
Plaque index
Time frame: Baseline, Day 7
The amount of plaque was scored.
Gingival index
Time frame: Baseline, Day 7
The gingival status was scored.
Probing depth
Time frame: Baseline, Day 7
The periodontal pocket depth was performed (mm).
Clinical attachment level
Time frame: Baseline, Day 7
The clinical attachment level was measured (mm).
Bleeding on probing
Time frame: Baseline, Day 7
The gingival status was scored.(%)
Epithelialization with plaque staining agent
Time frame: Day 1, 3, and 7
The wound surface epithelialization was observed with plaque staining agent. The wound surface was stained with plaque staining dye and the dark colored area is calculated as mm2.
Epithelialization with H2O2
Time frame: Day 3 and 7
The wound surface epithelialization was observed with H2O2. Scored as foaming present/absent after application with H2O2
Histological analysis
Time frame: Day 1, 3, and 7
Histological analysis evaluated epithelial keratinization, regeneration, and/or degeneration during the healing process and to obtain epithelial samples repeatedly. The number of keratinocytes was counted.
postoperative pain with Visiual Analogue Scale (VAS)
Time frame: Day 3 and 7
VAS scores were taken on the 3rd and 7th days without any intervention to the patient. Scored between 1-10 as 1 was no pain, 10 was pain.
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 6 Jan 2025.
- Background: PubMed 35578822Burian EA, Sabah L, Kirketerp-Moller K, Gundersen G, Agren MS. Effect of Stabilized Hypochlorous Acid on Re-epithelialization and Bacterial Bioburden in Acute Wounds: A Randomized Controlled Trial in Healthy Volunteers. Acta Derm Venereol. 2022 May 31;102:adv00727. doi: 10.2340/actadv.v102.1624.
- 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.
Sema Nur Sevinç Gül, Dr. principal investigator
Ataturk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypochlorous acid in people with Wound Healing, run by Ataturk University at 1 site in Turkey (Türkiye).
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 4 inclusion and 4 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 6 Jan 2025. 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 Turkey (Türkiye). 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. Some participants in this study may receive a placebo. 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 (time frame: Baseline, Day 7). The study lists 9 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 NCT06760403, which also lists 1 linked publication.
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 6 Jan 2025.