Gingivitis
Conditions
Keywords
randomized controlled clinical trial, clinical trial
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.
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)
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.
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.
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.
Sponsors
Oman Dental College
IMU University, Malaysia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Masking description
STATISTICIAN
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Plaque Index (PI) | 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. |
| Change in Gingival Index (GI) | 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. |
Countries
Oman
Contacts
PRINCIPAL_INVESTIGATORTriveni Mohan Nalawade, PhD
Oman Dental College
Outcome results
None listed