Impacted Third MolarNCT07627945
Natural Enzyme Mouthwash After Third Molar Surgery
A study testing ORAL7® Mouthwash and 0.2% Chlorhexidine Gluconate Mouthwash in people with Impacted Third Molar and Postoperative Pain, run by MBD MARKETING SDN. BHD. at 1 site in Malaysia.
Trial summary
This clinical study investigates whether a natural enzyme-containing mouthwash (ORAL7®) can improve healing, pain and mouth opening after the surgical removal of impacted lower wisdom teeth (mandibular third molars), compared to a commonly used antiseptic mouthwash (0.2% chlorhexidine gluconate). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Impacted Third Molar, Postoperative Pain, Trismus
- What is being tested?
- ORAL7® Mouthwash and 0.2% Chlorhexidine Gluconate Mouthwash
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteMalaysia
- Study dates
- 6 Oct 2025to 22 Jun 2026
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years old and older until required number of samples has been obtained
- Impacted mandibular third molar required bone removal
- Absence of acute infection in impacted mandibular third molar
- Absence of deep caries in the adjacent tooth
- No known medical illness
- No known drug allergy
- Not on medication (prescribed or over the counter)
Who cannot join
- 1 Mandibular third molar with soft tissue impaction only
- Distoangulated tooth with deep impaction.
- Active smoker
- Pregnant women
- Patients undergoing removal of impacted mandibular third molar due to trauma justification, such as the impacted tooth is at the fractured site.
- Mentally challenged patient
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
Oral and Maxillofacial Surgery Unit, School of Dental Sciences, Universiti Sains Malaysia
Kota Bharu, Kelantan, 16150
About this study
Official title: The Effects of Natural Enzyme-Containing Mouthwash in Wound Healing After Surgical Removal of Impacted Mandibular Third Molar
This clinical study investigates whether a natural enzyme-containing mouthwash (ORAL7®) can improve healing, pain and mouth opening after the surgical removal of impacted lower wisdom teeth (mandibular third molars), compared to a commonly used antiseptic mouthwash (0.2% chlorhexidine gluconate).
Wisdom tooth removal is a routine dental surgery, but it can lead to common postoperative problems such as pain, swelling, difficulty in opening the mouth, and delayed healing of the surgical wound. After surgery, patients are usually advised to use an antiseptic mouthwash to reduce bacteria in the mouth and support healing. Chlorhexidine mouthwash is widely used for this purpose, but it may cause side effects such as tooth staining, taste disturbance, and irritation in some patients.
Read more
ORAL7® is a newer type of mouthwash that contains natural enzymes similar to those found in saliva, including lactoperoxidase, lysozyme, lactoferrin, and glucose oxidase. These enzymes help the mouth's natural defense system by reducing harmful bacteria, controlling inflammation, and supporting tissue repair. Because of these properties, ORAL7® may offer a gentler alternative to chlorhexidine while still promoting good healing.
The study will involve patients undergoing surgical removal of impacted lower wisdom teeth. After surgery, participants will be randomly assigned to use either ORAL7® mouthwash or 0.2% chlorhexidine mouthwash for one week. Neither group will know which mouthwash they are using in order to reduce bias. The researchers will then monitor healing by measuring wound recovery, pain levels, and how easily patients can open their mouths during the first week after surgery.
The main outcome being studied is how well the surgical wound heals after one week. Additional outcomes include the level of pain experienced each day and the degree of mouth opening after surgery.
Study Hypothesis
The study hypothesis is that patients using ORAL7® mouthwash will have similar or better wound healing, less postoperative pain, and improved mouth opening compared to patients using 0.2% chlorhexidine mouthwash after wisdom tooth surgery.
Read the detailed description
This study is a single-blinded, randomized controlled clinical trial designed to evaluate the effects of a natural enzyme-containing mouthwash (ORAL7®) on postoperative outcomes following the surgical removal of impacted mandibular third molars, in comparison with 0.2% chlorhexidine gluconate (CHX) mouthwash.
Postoperative management following third molar surgery typically includes antiseptic mouth rinses to reduce microbial load and support soft tissue healing. While chlorhexidine remains the standard adjunctive mouthwash due to its broad-spectrum antimicrobial activity, its use is associated with well-documented adverse effects, including tooth staining, taste alteration, and potential cytotoxic effects on oral tissues. These limitations have prompted increasing interest in alternative agents that can support oral wound healing while maintaining antimicrobial efficacy.
ORAL7® is an enzyme-based oral rinse formulated to mimic components of the innate salivary defense system. It contains lactoperoxidase, lysozyme, lactoferrin, and glucose oxidase, which collectively contribute to antimicrobial activity through enhancement of the lactoperoxidase-thiocyanate-hydrogen peroxide system. This enzymatic system supports microbial homeostasis, limits pathogenic bacterial growth, and may contribute to a more favorable environment for tissue repair without disrupting normal oral microflora to the same extent as conventional antiseptics.
The biological rationale for this intervention is based on the role of salivary enzymes in regulating inflammation, microbial colonization, and tissue regeneration. Lactoperoxidase generates antimicrobial hypothiocyanite ions, lysozyme disrupts bacterial cell walls and modulates inflammatory activity, lactoferrin regulates iron availability while supporting immune modulation and tissue repair, and glucose oxidase contributes to controlled hydrogen peroxide production that sustains enzymatic antimicrobial activity. Collectively, these mechanisms may influence early wound healing dynamics, postoperative discomfort, and functional recovery.
Eligible participants undergoing surgical extraction of impacted mandibular third molars under local anesthesia will be allocated into either the ORAL7® group or the CHX group using a randomized allocation method with allocation concealment. Postoperative care will be standardized across both groups except for the assigned mouthwash regimen.
Participants will be instructed to use the allocated mouthwash for a fixed period following surgery, and postoperative recovery will be monitored over the first week. Clinical assessments will focus on soft tissue healing status at the surgical site, patient-reported pain intensity, and functional limitation related to mouth opening. These outcomes reflect key domains of postoperative recovery in oral surgery, including tissue repair, inflammation-related discomfort, and functional impairment.
The study is designed to generate comparative clinical evidence regarding whether an enzyme-based oral rinse can provide equivalent or improved postoperative outcomes compared to chlorhexidine, particularly in terms of wound healing quality, pain reduction, and recovery of mandibular function. Findings may contribute to optimizing postoperative oral care protocols and reducing reliance on antiseptic agents with known side-effect profiles.
- Conditions
- Impacted Third Molar, Postoperative Pain, Trismus, Wound Healing
- Being tested
- ORAL7® Mouthwash, 0.2% Chlorhexidine Gluconate Mouthwash
- Keywords
- impacted mandibular third molar, ORAL7®, Chlorhexidine, wound healing, pain score, mouth opening
- Medical subject headings
- Pain, Postoperative, Trismus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ORAL7® MouthwashDrug
Enzyme-containing mouthwash used postoperatively after surgical removal of impacted mandibular third molars. Contains lactoperoxidase, lysozyme, lactoferrin, and glucose oxidase. Used as a 10 mL rinse for 30 seconds, three times daily for 7 days starting from postoperative day 1.
0.2% Chlorhexidine Gluconate MouthwashDrug
Standard antiseptic mouth rinse used following oral surgery. Participants rinse with 10 mL for 30 seconds, three times daily for 7 days starting from postoperative day 1.
| Study group | Role | What they receive |
|---|---|---|
| ORAL7® Enzyme-Containing Mouthwash Group | Experimental | ORAL7® Enzyme-Containing Mouthwash Group
Participants in this arm will receive ORAL7® mouthwash as the postoperative rinse following surgical removal of impacted mandibular third molars. ORAL7® is an enzyme-based oral rinse containing lactoperoxidase, lysozyme, lactoferrin, and glucose oxidase, which support the natural salivary antimicrobial system. Participants will be instructed to rinse with approximately 10 mL of the mouthwash for 30 seconds, three times daily for 7 days starting on the first postoperative day. Receives: Drug: ORAL7® Mouthwash |
| 0.2% Chlorhexidine Gluconate Mouthwash Group | Active comparator | 0.2% Chlorhexidine Gluconate Mouthwash Group
Participants in this arm will receive 0.2% chlorhexidine gluconate mouthwash as the postoperative rinse following surgical removal of impacted mandibular third molars. Chlorhexidine is a broad-spectrum antiseptic commonly used in oral surgery to reduce microbial load and support wound healing. Participants will be instructed to rinse with approximately 10 mL of the solution for 30 seconds, three times daily for 7 days starting on the first postoperative day. Receives: Drug: 0.2% Chlorhexidine Gluconate Mouthwash |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Score
Assessment of postoperative pain intensity using the Visual Analogue Scale (VAS) ranging from 0 to 10 following surgical removal of impacted mandibular third molars.
Measured: Daily from Postoperative Day 1 to Postoperative Day 7
Landry Wound Healing Index Score
Assessment of postoperative soft tissue healing using the Landry Wound Healing Index following surgical removal of impacted mandibular third molars. Healing will be evaluated based on tissue color, bleeding on palpation, granulation tissue, incision margin condition, and suppuration.
Measured: Postoperative Day 7
Postoperative Mouth Opening
Assessment of postoperative mouth opening measured in millimeters between the maxillary and mandibular incisal reference points following surgical removal of impacted mandibular third molars.
Measured: Preoperative baseline and Postoperative Day 7
Secondary outcomes (1)
Analgesic Consumption
Assessment of the total number of analgesic medications consumed following surgical removal of impacted mandibular third molars. Analgesic use will include prescribed celecoxib and rescue paracetamol intake recorded daily by participants.
Measured: Daily from Postoperative Day 1 to Postoperative Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start6 Oct 2025
- Primary completion15 Jun 2026
- Study completion22 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impacted Third MolarStudies 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
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- MBD MARKETING SDN. BHD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Dr. Nabeel Reza, MBD MARKETING SDN. BHD.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07627945
- Sponsor's protocol ID
- GAL007-0000000619-M206
- Status last verified
- Jun 2026
- First submitted
- 21 May 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Natural Enzyme-Containing Mouthwash in Wound Healing After Surgical Removal of Impacted Mandibular Third Molar
- ClinicalTrials.gov ID
- NCT07627945
- Acronym / sponsor ID
- GAL007-0000000619-M206
- Conditions
- Impacted Third Molar, Postoperative Pain, Trismus, Wound Healing
- Keywords
- impacted mandibular third molar, ORAL7®, Chlorhexidine, wound healing, pain score, mouth opening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- MBD MARKETING SDN. BHD.Industry (pharma, biotech, devices)
- Study start
- 6 Oct 2025 (actual)
- Primary completion
- 15 Jun 2026 (actual)
- Study completion
- 22 Jun 2026 (actual)
- First posted
- 4 Jun 2026 (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.
This clinical study investigates whether a natural enzyme-containing mouthwash (ORAL7®) can improve healing, pain and mouth opening after the surgical removal of impacted lower wisdom teeth (mandibular third molars), compared to a commonly used antiseptic mouthwash (0.2% chlorhexidine gluconate).
Wisdom tooth removal is a routine dental surgery, but it can lead to common postoperative problems such as pain, swelling, difficulty in opening the mouth, and delayed healing of the surgical wound. After surgery, patients are usually advised to use an antiseptic mouthwash to reduce bacteria in the mouth and support healing. Chlorhexidine mouthwash is widely used for this purpose, but it may cause side effects such as tooth staining, taste disturbance, and irritation in some patients.
ORAL7® is a newer type of mouthwash that contains natural enzymes similar to those found in saliva, including lactoperoxidase, lysozyme, lactoferrin, and glucose oxidase. These enzymes help the mouth's natural defense system by reducing harmful bacteria, controlling inflammation, and supporting tissue repair. Because of these properties, ORAL7® may offer a gentler alternative to chlorhexidine while still promoting good healing.
The study will involve patients undergoing surgical removal of impacted lower wisdom teeth. After surgery, participants will be randomly assigned to use either ORAL7® mouthwash or 0.2% chlorhexidine mouthwash for one week. Neither group will know which mouthwash they are using in order to reduce bias. The researchers will then monitor healing by measuring wound recovery, pain levels, and how easily patients can open their mouths during the first week after surgery.
The main outcome being studied is how well the surgical wound heals after one week. Additional outcomes include the level of pain experienced each day and the degree of mouth opening after surgery.
Study Hypothesis
The study hypothesis is that patients using ORAL7® mouthwash will have similar or better wound healing, less postoperative pain, and improved mouth opening compared to patients using 0.2% chlorhexidine mouthwash after wisdom tooth surgery.
Detailed description
This study is a single-blinded, randomized controlled clinical trial designed to evaluate the effects of a natural enzyme-containing mouthwash (ORAL7®) on postoperative outcomes following the surgical removal of impacted mandibular third molars, in comparison with 0.2% chlorhexidine gluconate (CHX) mouthwash.
Postoperative management following third molar surgery typically includes antiseptic mouth rinses to reduce microbial load and support soft tissue healing. While chlorhexidine remains the standard adjunctive mouthwash due to its broad-spectrum antimicrobial activity, its use is associated with well-documented adverse effects, including tooth staining, taste alteration, and potential cytotoxic effects on oral tissues. These limitations have prompted increasing interest in alternative agents that can support oral wound healing while maintaining antimicrobial efficacy.
ORAL7® is an enzyme-based oral rinse formulated to mimic components of the innate salivary defense system. It contains lactoperoxidase, lysozyme, lactoferrin, and glucose oxidase, which collectively contribute to antimicrobial activity through enhancement of the lactoperoxidase-thiocyanate-hydrogen peroxide system. This enzymatic system supports microbial homeostasis, limits pathogenic bacterial growth, and may contribute to a more favorable environment for tissue repair without disrupting normal oral microflora to the same extent as conventional antiseptics.
The biological rationale for this intervention is based on the role of salivary enzymes in regulating inflammation, microbial colonization, and tissue regeneration. Lactoperoxidase generates antimicrobial hypothiocyanite ions, lysozyme disrupts bacterial cell walls and modulates inflammatory activity, lactoferrin regulates iron availability while supporting immune modulation and tissue repair, and glucose oxidase contributes to controlled hydrogen peroxide production that sustains enzymatic antimicrobial activity. Collectively, these mechanisms may influence early wound healing dynamics, postoperative discomfort, and functional recovery.
Eligible participants undergoing surgical extraction of impacted mandibular third molars under local anesthesia will be allocated into either the ORAL7® group or the CHX group using a randomized allocation method with allocation concealment. Postoperative care will be standardized across both groups except for the assigned mouthwash regimen.
Participants will be instructed to use the allocated mouthwash for a fixed period following surgery, and postoperative recovery will be monitored over the first week. Clinical assessments will focus on soft tissue healing status at the surgical site, patient-reported pain intensity, and functional limitation related to mouth opening. These outcomes reflect key domains of postoperative recovery in oral surgery, including tissue repair, inflammation-related discomfort, and functional impairment.
The study is designed to generate comparative clinical evidence regarding whether an enzyme-based oral rinse can provide equivalent or improved postoperative outcomes compared to chlorhexidine, particularly in terms of wound healing quality, pain reduction, and recovery of mandibular function. Findings may contribute to optimizing postoperative oral care protocols and reducing reliance on antiseptic agents with known side-effect profiles.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ORAL7® Enzyme-Containing Mouthwash Group | Experimental | Drug: ORAL7® MouthwashORAL7® Enzyme-Containing Mouthwash Group Participants in this arm will receive ORAL7® mouthwash as the postoperative rinse following surgical removal of impacted mandibular third molars. ORAL7® is an enzyme-based oral rinse containing lactoperoxidase, lysozyme, lactoferrin, and glucose oxidase, which support the natural salivary antimicrobial system. Participants will be instructed to rinse with approximately 10 mL of the mouthwash for 30 seconds, three times daily for 7 days starting on the first postoperative day. |
| 0.2% Chlorhexidine Gluconate Mouthwash Group | Active comparator | Drug: 0.2% Chlorhexidine Gluconate Mouthwash0.2% Chlorhexidine Gluconate Mouthwash Group Participants in this arm will receive 0.2% chlorhexidine gluconate mouthwash as the postoperative rinse following surgical removal of impacted mandibular third molars. Chlorhexidine is a broad-spectrum antiseptic commonly used in oral surgery to reduce microbial load and support wound healing. Participants will be instructed to rinse with approximately 10 mL of the solution for 30 seconds, three times daily for 7 days starting on the first postoperative day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 years old and older until required number of samples has been obtained
- Impacted mandibular third molar required bone removal
- Absence of acute infection in impacted mandibular third molar
- Absence of deep caries in the adjacent tooth
- No known medical illness
Key exclusion criteria (6 listed)
- 1 Mandibular third molar with soft tissue impaction only
- Distoangulated tooth with deep impaction.
- Active smoker
- Pregnant women
- Patients undergoing removal of impacted mandibular third molar due to trauma justification, such as the impacted tooth is at the fractured site.
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 |
|---|---|---|
| ORAL7® MouthwashEnzyme-containing mouthwash used postoperatively after surgical removal of impacted mandibular third molars. Contains lactoperoxidase, lysozyme, lactoferrin, and glucose oxidase. Used as a 10 mL rinse for 30 seconds, three times daily for 7 days starting from postoperative day 1. | Drug | ORAL7® Enzyme-Containing Mouthwash Group |
| 0.2% Chlorhexidine Gluconate MouthwashStandard antiseptic mouth rinse used following oral surgery. Participants rinse with 10 mL for 30 seconds, three times daily for 7 days starting from postoperative day 1. | Drug | 0.2% Chlorhexidine Gluconate Mouthwash Group |
Primary outcome
Postoperative Pain Score
Time frame: Daily from Postoperative Day 1 to Postoperative Day 7
Assessment of postoperative pain intensity using the Visual Analogue Scale (VAS) ranging from 0 to 10 following surgical removal of impacted mandibular third molars.
Landry Wound Healing Index Score
Time frame: Postoperative Day 7
Assessment of postoperative soft tissue healing using the Landry Wound Healing Index following surgical removal of impacted mandibular third molars. Healing will be evaluated based on tissue color, bleeding on palpation, granulation tissue, incision margin condition, and suppuration.
Postoperative Mouth Opening
Time frame: Preoperative baseline and Postoperative Day 7
Assessment of postoperative mouth opening measured in millimeters between the maxillary and mandibular incisal reference points following surgical removal of impacted mandibular third molars.
1 secondary outcome
Analgesic Consumption
Time frame: Daily from Postoperative Day 1 to Postoperative Day 7
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 1 Jul 2026.
- 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.
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 ORAL7® Mouthwash and 0.2% Chlorhexidine Gluconate Mouthwash in people with Impacted Third Molar and Postoperative Pain, run by MBD MARKETING SDN. BHD. at 1 site in Malaysia.
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 7 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 1 Jul 2026. 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 Malaysia. 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?
Postoperative Pain Score (time frame: Daily from Postoperative Day 1 to Postoperative Day 7). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jul 2026.