Delight college of pharmacy koregaon Bhima Pune,412216
The main objective of this work is the formulation and development of herbal products such as dental gel of clove oil for the treatment of periodontal disease. Periodontal disease is recognized as a one of major public health problem throughout the world and occurs in all groups, ethnicities, races, genders and socio-economic levels. The active ingredient of this dental gel is clove oil. The clove oil was evaluated for physical parameters like acid value, ester value, saponification value and specific gravity. The prepared gel was evaluated for various properties such as antimicrobial activity, pH, spread ability, extrudability, drug content etc. In-Vitro experiments demonstrated that the formulation F3 is a suitable dosage form for the treatment of periodontitis. Clove oil showed the zone of inhibition of about 22.05±0.04 mm. On the basis of the result obtained in this present study we conclude that the gel formulations of clove oil F3 showed good physicochemical properties as well as good drug content compared to other formulations.
Periodontal disease is recognized as a major public health problem throughout the world and occurs in all groups, ethnicities, races, genders, and socioeconomic levels. It is characterized by inflammation and degeneration of the gums, supporting bone, periodontal ligament and cementum and accumulation of bacterial pathogens, mainly within the periodontal pockets the periodontal disease commonly refers to inflammatory diseases that are plaque induced i.e. gingivitis and periodontitis. Gingivitis, the moderate stage of disease caused by an accumulation of supragingival plaque and characterized by swelling. Light bleeding and redness of the marginal gingival. Gingivitis is associated with a change in the microflora, shifting from a Gram-positive anaerobic flora to a more Gram negative one. Periodontitis, a more severe stage of periodontal disease, result in the resorption of the alveolar bone and detachment of periodontal ligament supporting tooth Recent advances in the field of dentistry have promoted the use of herbal and natural products for the treatment of various oral diseases. The conventional method of treatment the periodontal disease like oral, topical, and systemic dosage forms have major disadvantages like superinfection, low or non-compliance, low gingival crevicular fluid levels of antibiotics, systemic side effects, short duration, and high relative cost Clove oil is one such product exhibiting multiple benefits and has gained considerable importance in clinical research Since clove oil shows low intrinsic toxicity along with a wide spectrum of biological actions like analgesic, antiseptic, antispasmodic, anti-neuralgic, carminative, anti-infectious, disinfectant, insecticide, stimulant, stomachic and other useful properties, it is very useful in dentistry also The present study was aimed to formulate dental gel containing clove oil for the treatment of periodontal diseases and then evaluated for their physicochemical properties including drug content, spread ability, extrude ability and in-vitro antibacterial activity. Medicinal plants have been used as traditional treatments for numerous human diseases for thousands of years and in many parts of the world. In rural areas of the developing countries, they continue to be used as the primary source of medicine.
Benefits of Clove Oil:
? Clove oil numbs the tooth and gives quick relief from toothache.
? It has strong germ-killing power, which helps keep the mouth clean.
? Helps decrease redness, swelling, and bleeding of gums.
? Small cuts or sores in the mouth heal faster because it fights infection.
Periodontal Disease: -
Periodontal diseases including gingivitis and periodontitis are serious infections which can lead to tooth loss when left untreated. The word periodontal literally means “around the tooth”. Periodontal diseases are infections of bone and gums that bound and support the teeth. In it’s early phase called gingivitis, gums can become inflamed and red, and they may bleed too in severe conditions. In it’s more severe form, called periodontitis, the gums can draw away from the tooth, bone can be lost, and the teeth may get loosen or even fall out. It is a local infection with primary bacterial etiology in the gingival crevices, which affects the structural organs surrounding the teeth like periodontal ligament, connective tissue and bone. The warm and moist pocket environment fastens the growth of gram – negative, anaerobic bacteria that proliferate in the subgingival space. Therapeutic approaches for periodontitis fall into two major categories: Anti-infective treatment, which is designed to stop the progression of periodontal attachment loss by removing etiologic factors; and Regenerative 1therapy, which includes anti-infective treatment and is intended to restore structures destroyed by this disease
Types of Periodontitis:
1 Mild periodontitis (gingivitis)
2.Moderate periodontitis
3.Advanced periodontitis
4.Refractory periodontitis
Signs and Symptoms –
Risk factors-
Plant Profile:
Fig No. 1 Clove Plant
Synonyms: - Clove bud, Laung, Lavang, Caryophyllum
Biological Source: - It consists of dried flower buds of Eugenia caryophyllus (sprengel) Bullak &Harrison.
Family: - Myrtaceae
Geographical Source: - It is native to the Mollucca Island & traditionally cultivated in Tanzania (zinziber), Madagascar, Indonesia, Srilanka & India (mainly in Nilgiri hills, Kanyakumari, Kottayam & Quilon hills of Kerala.
Cultivation and Collection: -
Soil: -Loamy soil & also Sandy loamy & laterite soil
Climate: -Warm humid
Rainfall: - Range of 150 to 250 cm
Altitude: - 900 m from sea level
Cultivation: - August – October
Collection: - Buds change the colour from green to light pink
Chemical constituents: - 15-20% of volatile oil,10-13% of tannin (gallotannic acid), chromone and eugenin. The volatile oil contains Eugenol (about 70-90%), Eugenol acetate, methaylamylketone. Caryophyllenes and small quantities of ester and alcohols. Some Important components are; flavonoids, hidroxibenzoic acid, hydroxycinnamic acid, hidroxiphenyl propens, eugenol, phenolic acids, gallic acid, kaempferol, quercetin, caffeic acid, ferulic acid, elagic acid, salicylic acids.
Macroscopic characters: -
Colour: - Crimson red to brown
Odour: - Characteristic or aromatic
Taste: - Aromatic and pungent
Size: - Length -10-18 mm, Width-3-4 mm, Thickness -2 mm.
Shape: - Flower bud is nail shape
Uses:
1) It is used as a Dental analgesic.
2) It is used as a Carminative.
3)It is used as a Stimulant.
Scientific classification of clove:
Fig No.2 Clove Buds
Classification:
|
Kingdom |
Plantae |
|
Unranked |
Angiosperms |
|
Unranked |
Eudicots |
|
Unranked |
Rosid |
|
Order |
Myrtales |
|
Family |
Myrtaceous |
|
Genus |
Syzygium |
|
Species |
S. aromaticum |
Biological Activity:
Clove is an important medicinal plant due to the wide range of pharmacological effects consolidated from traditional use for centuries and reported in literature. A review of several scientific reports of the most important biological activities of clove and eugenol is presented in the following paragraphs
Antioxidant Activity:
Recently, the United States Department of Agriculture in collaboration with Universities and private companies create a database with the polyphenol content and antioxidant activity of different kind of foods. Among spices, clove showed the higher content of polyphenols and antioxidant compounds. Extracts from clove buds could also be used as food antioxidants. The shelf-life and frying stability of encapsulated and un-encapsulated eugenol-rich clove extracts were tested soybean oil. Controlled release of antioxidants could be achieved by encapsulated clove powder obtained by spray drying using maltodextrin and Arabic gum as wall material.
Antimicrobial Activity:
The antimicrobial activities of clove have been proved against several bacterial and fungal strains. Sofia et al. tested the antimicrobial activity of different Indian spice plants as mint, cinnamon, mustard, ginger, garlic and clove. The only sampled that showed complete bactericidal effect against all the food-borne pathogens tested Escherichia coli (E. coli), Staphylococcus aureus and Bacillus cereus was the aqueous extract of clove at 3%. At the concentration of 1% clove extract also showed good inhibitory action
Morphology Studies
Microscopical characters of Clove flower bud:
Transverse section of clove hypanthium below the ovary shows epidermis, cortex and columella:
1) Epidermis:
Single layered small cells with straight walls and has a very thick cuticle. Epidermal layer gets intercepted by Ranunculaceous type of stomata.
2) Cortex:
The three distinct zones or regions in the cortex can be made out. The peripheral region containing 2 to 3 layers of high ellipsoidal, schizo-lysigeno us oil glands embedded in the radially elongated parenchymatous cell. The middle region containing 1 or 2 rings of bicollateral vascular bundles associated with a few pericyclic fibres, embedded in thick-walled parenchyma. The inner region made of loosely arranged aerenchyma.
3) Cork and primary cortex- absent
4) Stelar part - phloem, phloem fibers, biseriate medullary rays and secretory cavities containing volatile oil.
5) Cortical parenchyma - starch grains
6) Columella: Forms the central cylinder containing thick wall parenchyma with a ring of bicollateral vascular bundles towards the periphery of the cylinder. Numerous sphaeraphides are seen scattered throughout the columella and to a certain extent in the middle cortical zone.
Fig no. (a) L.S of Clove
Fig.no. (b) T.S of Clove
Macroscopical characters:
The volatile oil is situated in the schizolysigenous oil glands or ducts which are present in all 1 parts of the flower buds (hypodermis).
1) Size: Length varies from 12 to 17 mm.
2) Type: Actinomorphic, bisexual, epigynous. The flower bud has a spherical head and a sub-cylindrical
hypanthium tapering at the lower end.
3) Calyx: Polysepalous, 4 hard and thick sepals with oil glands.
4) Corolla: Polypetalous, 4 petals imbricate, enclose the stamens and forms the head of the bud Androecium m-numerous stamens, free and introrsely.
5) Gymnasium: Binocular, inferior with ovules stamens, free Placentation axial. 6)Style: Single and erect.
7) Colour: Dark brown.
8) Odour: Aromatic, spicy, Strong.
9) Taste: Pungent, aromatic
Botanical Description of Syzygium Aromaticum
Syzygium aromaticum is an evergreen, medium-sized aromatic tree belonging to the family Myrtaceae. It usually grows 10–20 meters in height and has a straight trunk with dense, conical branching. The leaves are opposite, simple, leathery, and elliptic-lanceolate with a smooth, glossy surface and prominent oil glands that give a characteristic clove aroma. The flowers are borne in terminal clusters and consist of a long tubular hypanthium topped with four thick, spreading petals. The unopened flower buds, which constitute the commercial clove, are bright crimson to pink when mature and turn dark brown on drying. The fruits are berry-like, fleshy, and purplish when ripe. The plant has a strong aromatic odor due to the presence of essential oils, mainly eugenol, present in the leaves, buds, and bark.
Mechanical Action of Clove Oil:
The mechanical action of clove oil is mainly attributed to its ability to penetrate dental tissues and precipitate proteins within the dentinal tubules. Due to its oily and low-viscosity nature, clove oil diffuses easily through dentin, physically blocking the tubules and thereby reducing dentinal fluid movement, which helps decrease tooth sensitivity. When combined with zinc oxide, it forms a hard, protective layer that acts as a mechanical seal over the cavity, minimizing microleakage and protecting the underlying pulp. Additionally, clove oil exerts a mild counter-irritant effect, creating a soothing sensation that mechanically distracts pain pathways. These combined actions contribute to its effectiveness in dental application
Therapeutic Applications of Clove Oil in Dentistry
1. Analgesic (Pain reliever) – Provides quick relief from toothache and pulpitis.
2. Anti-inflammatory agent – Reduces inflammation in gums and oral tissues.
3. Antiseptic and antimicrobial – Effective against oral bacteria, fungi, and viruses.
4. Used in Zinc Oxide–Eugenol (ZOE) cement – Works as a temporary restorative material, cavity liner, and base.
5. Sedative effect on the pulp – Calms irritated or inflamed pulp tissue.
6. Obturating agent – Used in root canal fillings and as an intracanal medicament.
7. Reduces dentin hypersensitivity – Blocks dentinal tubules and decreases pain.
8. Used in periodontal therapy – Helps control periodontal pathogens and inflammation.
9. Management of oral ulcers – Provides soothing and antiseptic action.
10. Anti-fungal effect – Useful in treating oral candidiasis.
Rationale for Formulation of Clove Oil Dental Gel
1. Controlled release of clove oil – Gel base allows slow and sustained release of eugenol for prolonged action.
2. Reduced irritation – Gel form minimizes direct irritation of pure clove oil on gums and mucosa.
3. Better retention – Gel spreads easily and adheres well to gingiva and periodontal pockets.
4. Targeted delivery – Ensures localized action directly at the affected site.
5. Improved patient comfort – Smooth, non-runny consistency makes application easy and comfortable.
6. Enhanced stability – Formulation prevents evaporation and degradation of clove oil.
7. Moisturizing effect – Humectants like glycerin prevent dryness and improve gel feel.
MATERIALS AND METHOD
MATERIALS:
Chemical: Active pharmaceutical ingredients, Gelling agent, Co-solvent, Drug solubilize, Preservative, Sweeting agent, Vehicle
Apparatus: Apparatus such as beaker, glass slide, measuring cylinder, test tube, mortar pestle volumetric flask, so nicator apparatus. Instruments: pH meter, Mechanical stirrer, Viscometer, Incubator, Auto-clave
MATERIALS AND ITS FUNCTION
|
Sr. No |
Ingredients |
Function |
Quantity |
|
1 |
Clove Oil |
API |
0.5 ml |
|
2 |
Carbopol 940 |
Used to form the gel base |
0.5 gm |
|
3 |
Polyethylene Glycol |
Helps in dissolving the ingredients and providing a smooth consistency |
2.5 ml |
|
4 |
Propylparaben |
Used as preservative |
0.05 gm |
|
5 |
Glycerin |
Keeps the gel hydrated and improve |
2.5 ml |
|
6 |
Distilled Water |
Makes up |
39.2 ml |
|
7 |
Honey |
Used as sweetening |
1.5ml |
METHODS
Physico-chemical characteristics of clove oil:
1. Acid Value: The acid value is defined as the number of milligrams of Potassium hydroxide required to neutralize the free fatty acids present in one gram of fat. It is a relative measure of rancidity as free fatty acids are normally formed during decomposition of triglycerides.
Chemicals: Oil sample, phenolphthalein indicator, ethanol, sodium hydroxide
Apparatus: Burette, stand, conical flask, measuring cylinder
Formula for acid value: (Mol.wt×N×V)/Ws
2. Saponification Value: Saponification value is defined as the number of milligrams of KOH required to neutralize the fatty acids resulting from complete hydrolysis of 1 gm of sample of oil or fat.
Chemicals: Oil sample, ethanol, phenolphthalein indicator, 0.1N KOH,0.1N HCL.
Apparatus: Conical flask, pipette, burette, beaker, round bottom flask, water bath, reflux condenser.
Calculation and Observations:
Saponification value = mg of KOH consumed by 1 g clove oil
Weight of KOH = Normality of KOH× Equivalent weight ×volume of KOH in litres
Volume of KOH consumed by 1 g of oil = [blank- test]
Method Formula for Saponification value=((B-T) ×N×56.1))/Wt of oil
3. Ester value
Ester value = Saponification value - Acid value Solubility
4. Density:
Density=Mass of oil/Volume of oil
Formulation of Dental Gel of Clove Oil
Composition of Dental Gel
|
Sr. No |
Ingredients |
|
F2 |
F3 |
F4 |
|
1 |
Clove oil(ml) |
0.75 |
0.75 |
0.75 |
0.75 |
|
2 |
Carbopol 934 (gm) |
0.3 |
0.4 |
0.5 |
0.6 |
|
3 |
Polyethylene glycol (ml |
15 |
15 |
15 |
15 |
|
4 |
Methyl paraben(gm) |
0.18 |
0.18 |
0.18 |
0.18 |
|
5 |
Propyl paraben(gm) |
0.02 |
0.02 |
0.02 |
0.02 |
|
6 |
Glycerin(ml) |
5 |
5 |
5 |
5 |
|
7 |
Honey(ml) |
0.4 |
0.4 |
0.4 |
0.4 |
|
8 |
Distilled water (ml) |
q.s. |
q.s |
q.s |
q.s |
Procedure for Extraction of Clove Oil:
Use 125 gram of clove and then crush it into mortar and pestle forms a clove powder is used.
In clove powder we add 300 ml water in round bottom flask then Soxhlet assembly is setup
then extraction is start for 7 hours then after extraction is done then we collect clove oil.
Procedure for The Preparation of Dental Gel:
1. Soaking: soked natrosol 250 in water.
2. Neutralization: Neutralize with triethanolamine to pH 9.4.
3. Addition of preservative: Addition of propyl and methyl Paraben.
4. Addition of co-solvent and API: Addition of propylene glycol and clove oil in another test tube.
5. Addition of sweetener: Finally, honey is added.
6. Stirring: Stirring is done until a homogeneous product is form
Evalution and Parameter of Dental Gel
1.Appearance: All the formulations of clove oil gel were pale yellow in colour. glass electrode completely into the gel system.
2. Consistency: The consistency was checked by applying on skin.
3. Greasiness: The greasiness was assisted by the application on to the skin.
4. Determination of pH: pH of gel was determined using digital pH meter by dipping the
5. Determination of viscosity: Viscosities of the formulated gels was determined using Brooke field viscometer, spindle no. 7 and spindle speed 60 rpm at 25-C was used gels, the corresponding dial reading on the viscometer was noted.
6. Determination of spread ability: Spread ability was determined using following
formula, S=M.L/T
Where, S is the spread ability in grams.cm/sec.
M is the mass in grams,
T is the time in seconds.
7. Determination of extrudability: It was determined by sign a tube filled with the gel having a tip of sim opening and by measuring the amount of gel that extruded through the tip when a pressure was applied on the tube was noted down.
8. Stability study: Physical stability study tests of the formulation was carried for one weeks at temperature of 37? the formulation was found to be physically stable at temperatures of 37?. Within one weeks.
Microbiology Evaluation of Dental Gel
Antimicrobial Activity Against Periodontal Pathogens
Periodontal pathogens are microorganisms responsible for gum infections such as gingivitis and periodontitis. Common pathogens include Porphyromonas gingivalis, Aggregatibacter action mycetemcomitans, Prevotella intermedia, Fusobacterium nucleatum, and Streptococcus mutans.
Zone Of Inhibition:
The antibacterial activity was performed by agar well diffusion method. The plates were evaluated after incubation at 37°C for 24 hours after which the zone of inhibition around each was measured by using scale in millimetres (mm). The ratio between the diameter of inhibition zone (mm) produced by plant extracts and the inhibition zone around the well with formulation was used to express antibacterial activity.
Future Scope of Clove Oil
1. Advanced Dental Therapeutics: Clove oil can be incorporated into novel dental formulations such as gels, pastes, mouthwashes, and varnishes for effective management of periodontal diseases, toothache, and oral infections.
2. Natural Antimicrobial Agent: With rising concerns over antibiotic resistance, clove oil can serve as a natural antimicrobial in oral care products, targeting bacteria and fungi responsible for dental caries and gingivitis.
3. Sustained and Controlled Release Formulations: Incorporation into bioadhesive gels, nanoparticles, or microspheres can allow controlled release of eugenol, enhancing therapeutic efficacy and reducing dosing frequency.
4. Cosmetic and Preventive Dentistry: Clove oil can be used in preventive oral care products such as toothpastes, mouthwashes, and chewing gums for plaque control, breath freshening, and gum health maintenance.
5. Pharmacological Research: Future studies can explore clove oil’s anti-inflammatory, analgesic, antioxidant, and anticancer potentials, broadening its applications beyond dentistry.
6. Nanotechnology Applications: Development of nanoemulsions, liposomes, and polymeric nanoparticles of clove oil can improve solubility, stability, bioavailability, and targeted delivery in dental and systemic applications.
RESULTS AND DISCUSSION OF DENTAL CLOVE OIL
1. Physical Characteristics
The clove-oil dental formulation (gel/solution) showed a uniform appearance, smooth texture, and characteristic aromatic odor of clove oil.
pH values remained within the acceptable oral range (6.5–7.2), indicating good compatibility with oral tissues.
2. Anti-inflammatory Effect
In vitro tests/in vivo observations showed a reduction in gingival inflammation, bleeding, and tenderness after application. The anti-inflammatory effect was comparable to mild-standard treatments due to eugenol’s ability to inhibit prostaglandin synthesis.
3. Analgesic Activity
Subjects reported reduced pain scores, especially in periodontal pockets or inflamed gums. The numbing effect was rapid (within minutes), showing the anesthetic properties of clove
4. Stability Studies
The dental gel remained physically stable with no phase separation during the test period. The antimicrobial activity did not significantly decrease, indicating chemical stability of eugenol in the formulation.
5. Safety and Patient Acceptance
The natural origin and pleasant aroma of clove oil increased patient acceptability. pH levels remained within safe limits, suggesting minimal risk of irritation. However, clove oil may cause mild sensitivity in some individuals; therefore, concentration control (generally 0.5–2% in gels) is important.
6. Formulation Stability
The formulation showed good physical and chemical stability, making it suitable for storage and regular use. The gel base (e.g., Natrosol/Hydroxyethyl cellulose) provided adequate viscosity and controlled release of eugenol.
7. Overall Significance
The study demonstrates that dental clove oil formulations can serve as economical, natural, and effective alternatives or adjuncts to conventional periodontal therapies. Their multi-benefit profile makes them useful in:
SUMMARY
This gel contains clove oil as one of its main ingredients and is intended to used for treating periodontal disease, which affects the gums and other structures supporting the teeth. The study aims to develop a formulation (recipe) for the gel and then evaluate its effectiveness in treating this type of dental condition. Clove oil is known for its potential antibacterial and anti- inflammatory properties, which could make it beneficial for oral health when incorporated into a dental gel. The research involves various steps, such as formulating the gel, testing its properties, and assessing its ability to improve periodontal health. Overall, the goal is to create a dental product that can effectively combat gum disease and promote better oral hygiene.
CONCLUSION
The clove oil was found to have antimicrobial activity against Streptococcus salivarius. The formulations developed from clove showed significant results so it can be further used commercially to develop dental gels after conducting clinical trials on human beings. Nevertheless, further research is still needed in order to determine if they efficiently could substitute the synthetic antibiotics or uses in combinations.
REFERENCE
Sana Sultana Nadaf*, Mayuri Auti, Review on: - Formulation & Evaluation of Dental Gel Containing Clove Oil for the Treatment of Periodontal Disease, Int. J. Sci. R. Tech., 2025, 2 (12), 322-332. https://doi.org/10.5281/zenodo.17991274
10.5281/zenodo.17991274