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Enrolling by Invitation

NCT Number: NCT07535229

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

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.

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Key information

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oman Dental College

Muscat, 0116, Oman

About this study

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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: 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.

Other names: 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.

Other names: mouthwash

Primary outcomes

  1. Change in Plaque Index (PI)

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

    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.

  2. Change in Gingival Index (GI)

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

    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.

Sponsors and collaborators

Lead sponsor

Oman Dental College

Other

Registry information

Official study 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.

Acronym: FHEPIG

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 17, 2026
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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