GingivitisSJW-CHX-RMENCT07882771
St. John's Wort Oil Versus Chlorhexidine Mouthwash for Gingival Problems After Rapid Maxillary Expansion
A study testing St. John's Wort Oil and Chlorhexidine in people with Gingivitis and Maxillary Transversal Deficiency, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial was to learn whether St. John's wort (Hypericum perforatum) oil helps gum healing in children and adolescents aged 11 to 16 years after treatment with a rapid maxillary expansion appliance. Read more about this study
- Who is it for?
- Ages 11 to 16 years
- Conditions the study is for
- Gingivitis, Maxillary Transversal Deficiency
- What is being tested?
- St. John's Wort Oil and Chlorhexidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jun 2019to 10 Nov 2020
- 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 11 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age between 11 and 16 years Maxillary transverse deficiency with bilateral posterior crossbite requiring rapid maxillary expansion No systemic disease Ability to read and understand the informed consent form Voluntary participation with written informed consent from the participant and parent/legal guardian
Who cannot join
- Presence of systemic disease Severe facial deformity Not meeting the inclusion criteria
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Van Yuzuncu Yil University Faculty of Dentistry, Department of Orthodontics
Van, Van, 65080
About this study
Official title: Comparison of the Effectiveness of Different Mouthwashes on Gingival Problems Following Rapid Maxillary Expansion
The goal of this clinical trial was to learn whether St. John's wort (Hypericum perforatum) oil helps gum healing in children and adolescents aged 11 to 16 years after treatment with a rapid maxillary expansion appliance. This appliance widens the upper jaw, but it covers a large part of the palate and makes cleaning difficult, which can cause gum redness, bleeding, swelling and pain after the appliance is removed.
The main questions it aimed to answer were:
Read more
Does St. John's wort oil improve gum health after the appliance is removed? Does it reduce pain in the days after appliance removal?
Researchers compared St. John's wort oil with chlorhexidine mouthwash, a commonly used oral antiseptic, and with a control group that used no antiseptic product.
Participants:
Were randomly assigned to one of three groups after removal of the expansion appliance Used St. John's wort oil as a mouthrinse or chlorhexidine three times a day for 7 days, or used no product (control group) Had their gums examined before the appliance was placed, when it was removed, and 7, 14 and 30 days later Recorded their pain level on a 0-10 scale on several days after appliance removal
- Conditions
- Gingivitis, Maxillary Transversal Deficiency
- Being tested
- St. John's Wort Oil, Chlorhexidine
- Keywords
- Rapid maxillary expansion, Hypericum perforatum, St. John's wort oil, Chlorhexidine, Gingival inflammation, Orthodontic appliance
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
St. John's Wort OilOther
St. John's wort (Hypericum perforatum) oil was used as a mouthrinse three times daily for 7 days, starting after removal of the rapid maxillary expansion appliance. The product was dispensed in an identical, unlabeled bottle.
ChlorhexidineDrug
Chlorhexidine gluconate mouthwash was used as a mouthrinse three times daily for 7 days, starting after removal of the rapid maxillary expansion appliance. The product was dispensed in an identical, unlabeled bottle.
| Study group | Role | What they receive |
|---|---|---|
| St. John's Wort Oil | Experimental | Participants rinsed with St. John's wort (Hypericum perforatum) oil three times daily for 7 days after removal of the rapid maxillary expansion appliance. Receives: Other: St. John's Wort Oil |
| Chlorhexidine | Active comparator | Participants rinsed with chlorhexidine mouthwash three times daily for 7 days after removal of the rapid maxillary expansion appliance. Receives: Drug: Chlorhexidine |
| Control | No intervention | Participants received no mouthwash after removal of the rapid maxillary expansion appliance. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gingival Index (Löe & Silness)
Gingival inflammation was assessed using the Löe and Silness gingival index (score 0-3; 0 = normal gingiva, 3 = severe inflammation with tendency to spontaneous bleeding). Higher scores indicate worse gingival health.
Measured: Before appliance placement (baseline), at appliance removal, and 7, 14 and 30 days after appliance removal
Secondary outcomes (3)
Plaque Index (Silness & Löe)
Plaque accumulation was assessed using the Silness and Löe plaque index (score 0-3; 0 = no plaque, 3 = abundant plaque). Higher scores indicate more plaque accumulation.
Measured: Before appliance placement (baseline), at appliance removal, and 7, 14 and 30 days after appliance removal
Bleeding on Probing
Percentage of sites showing bleeding within 15 seconds after gentle probing. Higher percentages indicate more gingival inflammation.
Measured: Before appliance placement (baseline), at appliance removal, and 7, 14 and 30 days after appliance removal
Pain Intensity (Visual Analogue Scale)
Pain was self-reported by participants on a 10 cm visual analogue scale (0 = no pain, 10 = worst imaginable pain). Higher scores indicate more pain.
Measured: Days 2, 4, 5 and 6 after appliance removal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study start10 Jun 2019
- Primary completion10 Nov 2020
- Study completion10 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GingivitisStudies 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
- Model description
- Participants were randomly allocated to three parallel groups after removal of the rapid maxillary expansion appliance: St. John's wort oil mouthrinse, chlorhexidine spray, or no antiseptic agent (control).
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gönül Dinç, Yuzuncu Yil University
- Investigators
- SAADET ÇINARSOY CİĞERİM, assoc. prof., Principal investigator, Yuzuncu Yil University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07882771
- Sponsor's protocol ID
- 17.04.2019-08
- Acronym
- SJW-CHX-RME
- Status last verified
- Oct 2026
- First submitted
- 13 Oct 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made publicly available because the participants were minors and the informed consent forms did not include permission for public data sharing. De-identified data are available from the corresponding author upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of Different Mouthwashes on Gingival Problems Following Rapid Maxillary Expansion
- ClinicalTrials.gov ID
- NCT07882771
- Acronym / sponsor ID
- SJW-CHX-RME / 17.04.2019-08
- Conditions
- Gingivitis, Maxillary Transversal Deficiency
- Keywords
- Rapid maxillary expansion, Hypericum perforatum, St. John's wort oil, Chlorhexidine, Gingival inflammation, Orthodontic appliance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 10 Jun 2019 (actual)
- Primary completion
- 10 Nov 2020 (actual)
- Study completion
- 10 Nov 2020 (actual)
- First posted
- 20 Oct 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.
The goal of this clinical trial was to learn whether St. John's wort (Hypericum perforatum) oil helps gum healing in children and adolescents aged 11 to 16 years after treatment with a rapid maxillary expansion appliance. This appliance widens the upper jaw, but it covers a large part of the palate and makes cleaning difficult, which can cause gum redness, bleeding, swelling and pain after the appliance is removed.
The main questions it aimed to answer were:
Does St. John's wort oil improve gum health after the appliance is removed? Does it reduce pain in the days after appliance removal?
Researchers compared St. John's wort oil with chlorhexidine mouthwash, a commonly used oral antiseptic, and with a control group that used no antiseptic product.
Participants:
Were randomly assigned to one of three groups after removal of the expansion appliance Used St. John's wort oil as a mouthrinse or chlorhexidine three times a day for 7 days, or used no product (control group) Had their gums examined before the appliance was placed, when it was removed, and 7, 14 and 30 days later Recorded their pain level on a 0-10 scale on several days after appliance removal
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Participants were randomly allocated to three parallel groups after removal of the rapid maxillary expansion appliance: St. John's wort oil mouthrinse, chlorhexidine spray, or no antiseptic agent (control).
| Arm | Type | Receives |
|---|---|---|
| St. John's Wort Oil | Experimental | Other: St. John's Wort OilParticipants rinsed with St. John's wort (Hypericum perforatum) oil three times daily for 7 days after removal of the rapid maxillary expansion appliance. |
| Chlorhexidine | Active comparator | Drug: ChlorhexidineParticipants rinsed with chlorhexidine mouthwash three times daily for 7 days after removal of the rapid maxillary expansion appliance. |
| Control | No intervention | –Participants received no mouthwash after removal of the rapid maxillary expansion appliance. |
Who may qualify
- Ages
- 11 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Age between 11 and 16 years Maxillary transverse deficiency with bilateral posterior crossbite requiring rapid maxillary expansion No systemic disease Ability to read and understand the informed consent form Voluntary participation with written informed consent from the participant and parent/legal guardian
Key exclusion criteria (1 listed)
- Presence of systemic disease Severe facial deformity Not meeting the inclusion criteria
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 |
|---|---|---|
| St. John's Wort OilSt. John's wort (Hypericum perforatum) oil was used as a mouthrinse three times daily for 7 days, starting after removal of the rapid maxillary expansion appliance. The product was dispensed in an identical, unlabeled bottle. | Other | St. John's Wort Oil |
| ChlorhexidineChlorhexidine gluconate mouthwash was used as a mouthrinse three times daily for 7 days, starting after removal of the rapid maxillary expansion appliance. The product was dispensed in an identical, unlabeled bottle. | Drug | Chlorhexidine |
Primary outcome
Gingival Index (Löe & Silness)
Time frame: Before appliance placement (baseline), at appliance removal, and 7, 14 and 30 days after appliance removal
Gingival inflammation was assessed using the Löe and Silness gingival index (score 0-3; 0 = normal gingiva, 3 = severe inflammation with tendency to spontaneous bleeding). Higher scores indicate worse gingival health.
3 secondary outcomes
Plaque Index (Silness & Löe)
Time frame: Before appliance placement (baseline), at appliance removal, and 7, 14 and 30 days after appliance removal
Bleeding on Probing
Time frame: Before appliance placement (baseline), at appliance removal, and 7, 14 and 30 days after appliance removal
Pain Intensity (Visual Analogue Scale)
Time frame: Days 2, 4, 5 and 6 after appliance removal
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 20 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be made publicly available because the participants were minors and the informed consent forms did not include permission for public data sharing. De-identified data are available from the corresponding author upon reasonable request.
Related trials for Gingivitis
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Comparison of the Effects of Oral Hygiene Regimens on Clinical, Immunomodulatory, and Microbial Outcomes and Oral Tolerance in People With Gingivitis
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Active, not recruitingPhase 3
A Study to Assess the Efficacy of Two Brushing Regimens in the Reduction of Established Dental Plaque and Gingivitis
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Effectiveness of Personalized Digital Oral Health Intervention in Patients With Fixed Orthodontic Appliances.
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Not yet recruitingPhase 2
Efficacy of Thymus Vulgaris Mouthwash in the Management of Biofilm-Induced Gingivitis
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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.
SAADET ÇINARSOY CİĞERİM, assoc. prof. principal investigator
Yuzuncu Yil 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 St. John's Wort Oil and Chlorhexidine in people with Gingivitis and Maxillary Transversal Deficiency, run by Yuzuncu Yil 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 1 inclusion and 1 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 20 Oct 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 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. 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?
Gingival Index (Löe & Silness) (time frame: Before appliance placement (baseline), at appliance removal, and 7, 14 and 30 days after appliance removal). 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 20 Oct 2026.