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

Oman Dental College

Status: Invitation-only

Conditions: Gingivitis

Treatments: Other: Frankinscence and Thyme essence/ water based mouthwash; Drug: Chlorhexidine (0.2%); Other: Frankinscence and coconut Oil based mouthwash

Study type: Interventional

Funder types: Other

Identifiers

NCT07535229

BFP/URG/HSS25/293 (Other Identifier)

ODC-2024-AE-220B

Details and patient eligibility

About

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.

Full 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)

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 30 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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90 participants in 3 patient groups

Frankinscence and coconut Oil based mouthwash

Experimental group

Description:

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.

Treatment:

Other: Frankinscence and coconut Oil based mouthwash

Frankinscence essence and Thyme essence based mouthwash

Experimental group

Description:

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.

Treatment:

Other: Frankinscence and Thyme essence/ water based mouthwash

Chlorhexidine mouthwash

Active Comparator group

Description:

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

Treatment:

Drug: Chlorhexidine (0.2%)