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

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.

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Gingivitis
• Intervention / Treatment: Other: Frankinscence and coconut Oil based mouthwash; Other: Frankinscence and Thyme essence/ water based mouthwash; Drug: Chlorhexidine (0.2%)

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)

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Oman
  • Muscat, Oman, 0116
    • Oman Dental College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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.; Other Names: 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; 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.; Other Names: 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%); 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.; Other Names: mouthwash

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Difference for the mean gingival score from baseline to 21 days.
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.	Difference in the mean reduction of Plaque score from baseline to 21 days.

Collaborators and Investigators

• Sponsor: Oman Dental College
• Investigators: Principal Investigator: Triveni Mohan Nalawade, PhD, Oman Dental College

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): April 15, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: April 7, 2026
• First Submitted That Met QC Criteria: April 14, 2026
• First Posted (Actual): April 17, 2026

Study Record Updates

• Last Update Posted (Actual): April 23, 2026
• Last Update Submitted That Met QC Criteria: April 18, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: clinical trial; randomized controlled clinical trial
• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Infections; Gingival Diseases; Gingivitis; Organic Chemicals; Chemical Actions and Uses; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Specialty Uses of Chemicals; Biguanides; Guanidines; Amidines; Cosmetics; Chlorhexidine; Mouthwashes
• Other Study ID Numbers: ODC-2024-AE-220B; BFP/URG/HSS25/293 (Other Identifier: Ministry of Higher Education, Research and Innovation, Oman)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No