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

NCT07535229 | Enrolling By Invitation

• 2 other identifiers: ODC-2024-AE-220BBFP/URG/HSS25/293
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gingivitis

Keywords

randomized controlled clinical trial; clinical trial

Outcome Measures

Primary Outcomes (2)

• 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.

• 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.

Study Arms (3)

Frankinscence and coconut Oil based mouthwash

EXPERIMENTAL

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

Frankinscence essence and Thyme essence based mouthwash

EXPERIMENTAL

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

Chlorhexidine mouthwash

ACTIVE COMPARATOR

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

Frankinscence and coconut Oil based mouthwash OTHER

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

Frankinscence and coconut Oil based mouthwash

Frankinscence and Thyme essence/ water based mouthwash OTHER

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

Frankinscence essence and Thyme essence based mouthwash

Chlorhexidine (0.2%) DRUG

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

Chlorhexidine mouthwash

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oman Dental College: lead

Study Sites (1)

Oman Dental College

Muscat, 0116, Oman

Location

Related Publications (9)

• 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.

  PMID: 35342437 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 36869332 BACKGROUND

• 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.

  PMID: 22615671 BACKGROUND

• 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.

  PMID: 30696552 BACKGROUND

• 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.

  PMID: 35807419 BACKGROUND

• 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.

  PMID: 41488228 RESULT

• 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.

  PMID: 34466501 RESULT

• 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.

  RESULT

MeSH Terms

Conditions

Gingivitis

Interventions

Mouthwashes; Chlorhexidine

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Biomedical and Dental Materials; Specialty Uses of Chemicals; Chemical Actions and Uses; Cosmetics; Manufactured Materials; Technology, Industry, and Agriculture; Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Triveni Mohan Nalawade, PhD

  Oman Dental College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: STATISTICIAN
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 7, 2026
• First Posted: April 17, 2026
• Study Start: April 15, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

OM (1)