AzTrials
AzTrials

GingivitisFHEPIGNCT07535229

Frankincense and Herbal Extracts for Plaque-Induced Gingivitis: A Double-Blind RCT

A study testing Frankinscence and coconut Oil based mouthwash, Frankinscence and Thyme essence/ water based mouthwash and Chlorhexidine (0.2%) in people with Gingivitis, run by Oman Dental College at 1 site in Oman.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Frankincense, a natural resin obtained from trees of the Boswellia genus, has been traditionally used for its medicinal properties. It is well-documented for its antibacterial, anti-inflammatory, and analgesic effects, making it a candidate for therapeutic applications beyond its conventional uses. Read more about this study

Who is it for?
Ages 18 to 30 yearsHealthy volunteers can take part
Conditions the study is for
Gingivitis
What is being tested?
Frankinscence and coconut Oil based mouthwash, Frankinscence and Thyme essence/ water based mouthwash and Chlorhexidine (0.2%)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
99 participants
Where
1 siteOman
Study dates
19 Apr 2026to 7 May 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 to 30 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Gingival index >1
  • Periodontal pocket depth ≤ 3 mm
  • Clinical attachment loss "0"
  • Provision of written informed consent
  • Good systemic health.

Who cannot join

  • Severe periodontal disease, as characterized by purulent exudates, generalized mobility, and/or severe recession Any condition that requires antibiotic premedication for the administration of a dental prophylaxis.
  • Self-reported pregnancy, intent to become pregnant during the study, or breast-feeding.
  • Any diseases or condition that could be expected to interfere with the safe completion of the study.
  • History of antibiotic use in the previous 3 months. Individuals with orthodontic appliances or prosthetic appliances that would interfere with evaluation.

Trial locations and contacts

1 site in 1 country.

Oman1 site
  • Oman Dental College

    Muscat, 0116

Other trials in Oman

About this study

Official title: The Efficiency of Frankincense and Other Extracts in the Treatment of Mild to Moderate Plaque Biofilm Induced Gingivitis: a Double Blinded Randomized Controlled Trial.

Frankincense, a natural resin obtained from trees of the Boswellia genus, has been traditionally used for its medicinal properties. It is well-documented for its antibacterial, anti-inflammatory, and analgesic effects, making it a candidate for therapeutic applications beyond its conventional uses. Despite its known pharmacological benefits, scientific evidence supporting the use of frankincense in oral health care, particularly in the management of periodontal diseases, remains limited.

Gingivitis is one of the most common forms of gum disease, characterized by inflammation of the gingival tissues due to dental biofilm (plaque) accumulation. If left untreated, it can progress to periodontitis, leading to irreversible damage to the supporting structures of the teeth. Standard treatment approaches typically involve mechanical plaque control and the use of fluoride-based oral health care products, which are effective but may not be well-tolerated or preferred by all individuals.

Read more

This study aims to explore the potential of frankincense-based oral care products as a natural alternative or adjunct to conventional oral products in the management of gingivitis. By comparing the clinical outcomes of patients using a frankincense-containing oral health care product with those using a commercially available oral care product, the study seeks to evaluate the effectiveness of frankincense in reducing gingival inflammation, dental biofilm (plaque) accumulation, and associated symptoms. Thus, improve oral health mainly by reducing gum inflammation.

The findings could provide insights into the viability of incorporating natural products like frankincense into routine oral hygiene practice.

Read the detailed description

The Randomized Controlled Clinical study with parallel design would be used to assess and compare the efficacy of Frankinscence and coconut oil-based, Frankinscence and Thyme essence-based, and Chlorhexidine mouthwash on gingivitis. Subjects with gingivitis with age group of 18-40 years will be selected for the study as the target population. Subjects who meet the inclusion and exclusion criteria will be selected and screened for the plaque and gingival status before including them in the study. They will be randomly divided into three groups.

Group 1: 30 participants (Frankinscenceand coconut oil-based mouthwash) Group 2: 30 subjects (Frankinscence and Thyme essence-based mouthwash) Group 3: 30 subjects (Chlorhexidine mouthwash)

Conditions
Gingivitis
Being tested
Frankinscence and coconut Oil based mouthwash, Frankinscence and Thyme essence/ water based mouthwash, Chlorhexidine (0.2%)
Keywords
randomized controlled clinical trial, clinical trial
Medical subject headings
Gingivitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Frankinscence and coconut Oil based mouthwashOther

    Also called Mouthwash

    This intervention consists of Frankinscence oil and coconut oil and other herbal extracts. Frankinscence is supposed to have antiinflammatory activity and has been studied for its application in medical sciences for arthritis. Similarly organic virgin and extra virgin coconut oil has shown some inhibitory activity against streptococcus mutans. As per our review of literature and to the best of our knowledge no one has tried a combination of these 2 oils alongwith addition of some other oils to improve palability.

  • Frankinscence and Thyme essence/ water based mouthwashOther

    Also called mouthwash

    This intervention consists of Frankinscence essence and Thyme essence and other herbal extracts. Frankinscence is supposed to have antiinflammatory activity and similarly Thyme is widely used in the pharmaceutical field, mainly due to its germicidal and antiseptic properties of phenolic components. . As per our review of literature and to the best of our knowledge no one has tried a combination of these 2 essences alongwith addition of some other oils to improve palability.

  • Chlorhexidine (0.2%)Drug

    Also called mouthwash

    Chlorhexidine 0.2% mouthwash is considered the gold standard in dentistry for chemical plaque control and oral health care. It is a broad-spectrum antimicrobial agent effective against Gram-positive and Gram-negative bacteria, fungi, and some viruses. Its key advantage is substantivity, allowing it to bind to oral tissues and release slowly, providing prolonged action for up to 12 hours. This makes it highly effective in reducing plaque accumulation and gingival inflammation, especially in cases where mechanical cleaning is inadequate. It is commonly used in managing gingivitis, periodontitis, and in pre- and post-operative care to reduce infection risk. Despite its effectiveness, it may cause tooth staining and temporary taste alteration, so it is usually recommended for short-term use under professional guidance. Overall, its proven efficacy and reliability make it an essential adjunct in oral hygiene.

Study groups in NCT07535229
Study groupRoleWhat they receive
Frankinscence and coconut Oil based mouthwashExperimentalParticipants randomized to this arm will receive a herbal mouthwash formulated from frankincense oil, coconut oil and other herbal additives. Dosage and Administration: Participants will be instructed to use 10mL of the mouthwash Rinse for 30-60 seconds, twice daily (morning and evening) Avoid eating or drinking for at least 30 min. Duration of study: 21 days Instructions to Participants: Shake the bottle well before use (if phase separation occurs) Do not swallow the mouthwash Maintain regular oral hygiene practices (tooth brushing) but avoid using other mouth Outcome Relevance: This arm evaluates the anti-inflammatory, and oral health-promoting properties of frankincense and coconut oil, particularly their potential effects on: Plaque accumulation Gingival inflammation Safety Monitoring: Participants will be monitored for adverse effects such as: Oral irritation Allergic reactions Changes in taste perception.
Receives: Other: Frankinscence and coconut Oil based mouthwash
Frankinscence essence and Thyme essence based mouthwashExperimentalParticipants randomized to this arm will receive a herbal mouthwash formulated from frankincense essence, Thyme essence and other herbal additives. Dosage and Administration: Participants will be instructed to use 10mL of the mouthwash Rinse for 30-60 seconds, twice daily (morning and evening) Avoid eating or drinking for at least 30 min. Duration of study: 21 days Instructions to Participants: Shake the bottle well before use Do not swallow the mouthwash Maintain regular oral hygiene practices (tooth brushing) but avoid using other mouth Outcome Relevance: This arm evaluates the anti-inflammatory, and oral health-promoting properties of frankincense and thyme essences particularly their potential effects on: Plaque accumulation Gingival inflammation Safety Monitoring: Participants will be monitored for adverse effects such as: Oral irritation Allergic reactions Changes in taste perception.
Receives: Other: Frankinscence and Thyme essence/ water based mouthwash
Chlorhexidine mouthwashActive comparatorParticipants randomized to this arm will receive a commercially sourced standard antimicrobial mouthwash containing 0.2 % Chlorhexidine. Dosage and Administration: Use 10 mL of the mouthwash Rinse for 30-60 seconds, twice daily (morning and evening) Not to rinse with water immediately after use to allow sustained action Avoid eating or drinking for at least 30 minutes after rinsing Duration of intervention: 21 days Instructions to Participants: Use after routine tooth brushing Do not swallow the mouthwash Avoid concurrent use of other mouthwashes or oral antiseptic products during the study period Outcome Relevance: This arm serves as the active comparator (gold standard) to evaluate the efficacy of the experimental intervention for: Plaque inhibitory effects Reduction of gingival inflammation Participants will be monitored for: Tooth and tongue staining Altered taste sensation(Dysgeusia) Oral mucosal irritation or dryness Rare hypersensitivity reactions
Receives: Drug: Chlorhexidine (0.2%)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Plaque Index (PI)

    The primary outcome variable was the differences for the mean plaque score from baseline to 21 days.

    The plaque index ranges from 0-3 which is a continuous scale. '0' indicates no plaque on teeth (better score) ; and score '3' indicates abundance of plaque on the teeth (worst score).

    The index teeth of each participant were examined and plaque score is recorded. The score for each subject is added and divided by the total number of teeth examined.

    The average/mean plaque score obtained from each subject is added for all the subjects and divided by the total number of participants. Higher score indicates worst score.

    Measured: Difference in the mean reduction of Plaque score from baseline to 21 days.

  2. Change in Gingival Index (GI)

    The primary outcome variable was the differences for the mean gingival score from baseline to 21 days.

    The gingival index ranges from 0-3 which is a continuous scale. '0' indicates normal healthy gingiva without inflammation (better score) ; and score '3' indicates severe gingival inflammation (worst score).

    The index teeth of each participant were examined and gingival status is scored. The score for each subject is added and divided by the total number of teeth examined.

    The average/mean gingival score obtained from each subject is added for all the subjects and divided by the total number of participants. Higher score indicates worst score.

    Measured: Difference for the mean gingival score from baseline to 21 days.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Apr 2026
  2. Study start19 Apr 2026
  3. Primary completion7 May 2026
  4. Study completion7 May 2026

Resources

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 will be randomly assigned into three groups: Test Group 1: Frankinscence Oil-based mouthwash Test Group 2: Frankinscence Essence / Water-based mouthwash Control Group: Commercial chlorhexidine mouthwash (CHX) Blinding All products will be dispensed in identical, unlabelled black colored containers. Both participants and clinical examiners will be blinded to group allocation to reduce bias. The above specified 3 groups will be assigned with the respective interventions for 3 weeks. other factors that influence gingival health will be standardized by giving them brushing technique demo and us eof standardized brushes, toothpastes aand dental floss. Records of plaque and gingival indices will be recorded at baseline, 14 th day and 21st day.
Masking
Triple blind
Who is masked
Care provider, Investigator, Outcomes assessor
Enrolment
99 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07535229
Sponsor's protocol ID
ODC-2024-AE-220B
Other IDs
BFP/URG/HSS25/293
Acronym
FHEPIG
Status last verified
Apr 2026
First submitted
7 Apr 2026
Last updated
2 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Data privacy of the patients. Patient data privacy is essential in dentistry to protect sensitive personal and medical information from unauthorized access or misuse. Dental professionals handle records such as medical histories, treatment plans, and personal details, making confidentiality a key responsibility. Information should only be accessed by authorized staff and shared with third parties, like insurance providers, with patient consent or legal obligation. With digital records, strong security measures are vital, including encryption, secure systems, and controlled access. Regular staff training helps prevent data breaches and accidental disclosure. Legal frameworks such as HIPAA and GDPR ensure that patient information is handled responsibly and securely. Patients also have rights to access, review, and request corrections to their data, promoting transparency and trust. Overall, maintaining data privacy ensures ethical practice and strengthens patient confidence in dental c

Publications

  • Soltani R, Saberi Z, Ghanadian SM, Taheri A, Entezarhojjat A. The effectiveness of olibanum orally disintegrating tablet in the treatment of oral aphthous ulcers: A randomized, double-blind, placebo-controlled clinical trial. J Res Med Sci. 2022 Jan 29;27:8. doi: 10.4103/jrms.jrms_247_21. eCollection 2022.

    PubMed 35342437
  • Muresan, S.M., Muresan, C.C., Mironescu, A., Surlin, P., Popescu, S.M. and Popescu, D.M., 2023. Dental hydrogels with essential oils with potential activity in periodontitis. Applied Sciences, 13(3), p.1787. https://doi.org/10.3390/app13031787.

  • Mohsenzadeh A, Karimifar M, Soltani R, Hajhashemi V. Evaluation of the effectiveness of topical oily solution containing frankincense extract in the treatment of knee osteoarthritis: a randomized, double-blind, placebo-controlled clinical trial. BMC Res Notes. 2023 Mar 4;16(1):28. doi: 10.1186/s13104-023-06291-5.

    PubMed 36869332
  • Khosravi Samani M, Mahmoodian H, Moghadamnia A, Poorsattar Bejeh Mir A, Chitsazan M. The effect of Frankincense in the treatment of moderate plaque-induced gingivitis: a double blinded randomized clinical trial. Daru. 2011;19(4):288-94.

    PubMed 22615671
  • Daly S, Seong J, Newcombe R, Davies M, Nicholson J, Edwards M, West N. A randomised clinical trial to determine the effect of a toothpaste containing enzymes and proteins on gum health over 3 months. J Dent. 2019 Jan;80 Suppl 1:S26-S32. doi: 10.1016/j.jdent.2018.12.002.

    PubMed 30696552
  • Almeida-da-Silva CLC, Sivakumar N, Asadi H, Chang-Chien A, Qoronfleh MW, Ojcius DM, Essa MM. Effects of Frankincense Compounds on Infection, Inflammation, and Oral Health. Molecules. 2022 Jun 29;27(13):4174. doi: 10.3390/molecules27134174.

    PubMed 35807419
  • Alghamdi N, Alshamrani L, Alboryah S, Alsenan JF, Alshehri T, Abogazalah NN, Balhaddad AA. The Effect of Coconut and Frankincense Oils on the Biofilm Growth of Streptococcus mutans. F1000Res. 2025 Sep 1;14:846. doi: 10.12688/f1000research.168621.1. eCollection 2025.

    PubMed 41488228
  • Khoshbakht Z, Khashabi E, Khodaie L, Torbati M, Lotfipour F, Hamishehkar H. Evaluation of Herbal Mouthwashes Containing Zataria Multiflora Boiss, Frankincense and Combination Therapy on Patients with Gingivitis: A Double-Blind, Randomized, Controlled, Clinical Trial. Galen Med J. 2019 Jul 15;8:e1366. doi: 10.31661/gmj.v8i0.1366. eCollection 2019.

    PubMed 34466501
  • Yousef, D.A., El Sayed, H.S., Abd El Ghaffar, M.M., and Ramadan, M.F., 2024. The adjunctive effect of frankincense extract gel to nonsurgical treatment of chronic periodontitis: A randomized clinical study. Tanta Dental Journal, 21(3), pp.312-318. https://doi.org/10.4103/tdj.tdj_28_24.

Questions about this trial

What is this clinical trial studying?

A study testing Frankinscence and coconut Oil based mouthwash, Frankinscence and Thyme essence/ water based mouthwash and Chlorhexidine (0.2%) in people with Gingivitis, run by Oman Dental College at 1 site in Oman.

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 5 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 2 Sep 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 Oman. 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?

Change in Plaque Index (PI) (time frame: Difference in the mean reduction of Plaque score from baseline to 21 days.). The study lists 2 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 NCT07535229, which also lists 9 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 2 Sep 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in