ClinicalTrials.gg
CompletedNCT07535229FHEPIGUpdated Sep 2, 2026

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

An interventional study of Frankinscence and coconut Oil based mouthwash and Frankinscence and Thyme essence/ water based mouthwash in Gingivitis, sponsored by Oman Dental College. Completed at 1 site in Oman. Open to participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-02.

Sponsored by Oman Dental College · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
99
Allocation
Randomized
Ages
18 Years to 30 Years
Sex
All
01

Study 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. 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.

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)

02

Conditions studied

  • Gingivitis

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Keywords

  • randomized controlled clinical trial
  • clinical trial
03

In context

Gingivitis

631 studies on the registry are indexed under Gingivitis; 107 are open to participants now.

This study's enrollment of 99 is above the median of 66 across 507 interventional studies indexed under Gingivitis.

Browse Gingivitis studies →

Lead sponsor

Oman Dental College is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 30 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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.

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Care provider, Investigator, Outcomes assessor)
Enrollment
99 participants (actual)

Study arms

  • Experimental
    Frankinscence and coconut Oil based mouthwash

    Participants 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.

    Other: Frankinscence and coconut Oil based mouthwash

  • Experimental
    Frankinscence essence and Thyme essence based mouthwash

    Participants 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.

    Other: Frankinscence and Thyme essence/ water based mouthwash

  • Active comparator
    Chlorhexidine mouthwash

    Participants 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

    Drug: Chlorhexidine (0.2%)

Interventions

  • OtherFrankinscence and coconut Oil based 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.

    Also known as: Mouthwash

  • OtherFrankinscence and Thyme essence/ water based 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.

    Also known as: 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.

    Also known as: mouthwash

06

What researchers measure

Primary outcomes

  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.

    Time frame: 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.

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

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Study locations

1 site
  • Oman Dental College
    Muscat, 0116, Oman
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References and documents

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.

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: 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

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07535229
Lead sponsor
Oman Dental College
Collaborators
IMU University, Malaysia
Responsible party
Sponsor
First posted
Apr 17, 2026
Start date
Apr 19, 2026
Primary completion
May 7, 2026
Completion
May 7, 2026
Last update
Sep 2, 2026

Study contacts

Triveni Mohan Nalawade, PhD
principal investigator · Oman Dental College

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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